BEUDAMED
    Product Code: LCX FDA class 2 21 CFR 862.1155

    Kit, Test, Pregnancy, Hcg, Over The Counter

    Clinical Chemistry

    An over-the-counter pregnancy test kit using human chorionic gonadotropin (hCG) detection is a home-use diagnostic device that detects the presence of hCG in urine to indicate whether a woman is pregnant, providing a rapid, qualitative result without laboratory equipment. It is classified as FDA Class 2, reflecting moderate risk and the requirement for 510(k) premarket clearance. The product code is LCX, regulated under 21 CFR 862.1155, in the Clinical Chemistry specialty. Third-party review eligibility applies.

    View on FDA
    510(k)s
    224
    FEI Numbers
    124
    Registration Numbers
    124
    Unique Applicants
    126
    Years Active
    47

    Basic Information

    Product Code
    LCX
    Device Class
    FDA class 2
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 224 510(k) clearances via K numbers.

    K Number Device Name
    K250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
    K242135 Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
    K243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
    K241394 iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
    K240242 HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
    K241978 Shinetell Digital Pregnancy Test
    K240643 MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    K232715 Distinct® Digital Pregnancy Test
    K233624 HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
    K234152 ACESO Early Pregnancy Test
    K233174 FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream
    K240025 Clearblue® Early Detection Pregnancy Test
    K232864 EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
    K230741 Macro & Micro-Test HCG Pregnancy Test Midstream
    K230038 MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
    K222305 MissLan™ Digital Pregnancy Rapid Test
    K213379 Clearblue ® Early Pregnancy Test
    K212418 hCG One Step Pregnancy Test
    K213808 Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
    K210341 One Step Pregnancy Test
    K212447 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
    K200913 Clearblue® Early Digital Pregnancy Test
    K203246 Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
    K193318 Distinct® Early Detection Pregnancy Test
    K200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
    K193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
    K192843 INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
    K192123 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
    K182328 VeriClear Digital Early Result Pregnancy Test
    K190705 WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
    K181551 DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
    K183097 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
    K180771 Acro HCG Pregnancy Rapid Test
    K172627 David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
    K173229 Preview Digital Pregnancy Test
    K172512 ACRO HCG Pregnancy Rapid Test
    K171136 LIA Pregnancy Test
    K142754 Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
    K150063 One Step hCG Pregnancy Test
    K150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
    K132085 ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
    K131236 UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
    K123567 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
    K123436 FIRST RESPONSE EARLY RESULT PREGNANCY TEST
    K131931 CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
    K123703 HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
    K122907 FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
    K123050 EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
    K112449 QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
    K103487 FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
    K102760 ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
    K103574 PREGNANCY ONE STEP RAPID TEST
    K110889 IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
    K110433 CLEARBLUE EASY PREGNANCY TEST
    K081150 RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
    K083716 FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
    K071930 ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
    K062703 ONE STEP HCG PREGNANCY TEST
    K062096 KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
    K070054 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
    K053236 DAVID PREGNANCY TEST (MIDSTREAM)
    K061769 E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
    K060825 MULTI-USE ELECTRONIC PREGNANCY TEST
    K060128 CLEARBLUE EASY DIGITAL PREGNANCY TEST
    K053452 PURE-AID PREGNANCY TEST
    K053138 MYSET PREGNANCY TEST
    K060019 ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
    K051963 BE-CERTAIN PREGNANCY TEST
    K050305 ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
    K050546 ACON +/- MIDSTREAM PREGNANCY TEST
    K050930 E.P.T. CERTAINTY PREGNANCY TEST
    K043231 PROOF POSITIVE ELECTRONIC PREGNANCY TEST
    K043443 ONE STEP HCG URINE PREGNANCY TEST
    K040866 FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
    K042280 FACT PLUS ONE-STEP PREGNANCY TEST KIT
    K042151 ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
    K041748 AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
    K041404 CLEARBLUE EASY EASY READ PREGNANCY TEST
    K041273 ONE-STEP PREGNANCY TEST
    K040341 CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
    K040329 MODIFICATION TO E.P.T. PREGNANCY TEST
    K033658 E.P.T. PREGNANCY TEST
    K033041 ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
    K032992 UNIMARK HOME PREGNANCY TEST DEVICE
    K031798 GOOD MORNING TEST
    K032939 EPT CERTAINTY PREGNANCY TEST
    K032661 ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
    K032510 ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
    K032159 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
    K031271 ONE-STEP PREGNANCY TEST
    K030659 CLEARBLUE EASY DIGITAL PREGNANCY TEST
    K030533 ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
    K023037 MID STREAM PREGNANCY TEST
    K030258 FIRST RESPONSE PREGNANCY TEST
    K023638 CASSETTE/URINE HCG
    K023027 PREG-Q EARLY PREGNANCY TEST
    K023699 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
    K023126 AMEDITECH IMMUTEST HCG PREGANCY TEST
    K013907 INVERNESS MEDICAL EARLY PREGNANCY TEST
    K013372 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
    K011551 SURE CHECK PREGNANCY TEST
    K012215 QUIK-CHECK HOME PREGNANCY TEST
    K002049 INVERNESS MEDICAL EARLY PREGNANCY TEST
    K993483 ACON ONE STEP HOME PREGNANCY TEST STRIP
    K992232 FIRST RESPONSE 1-STEP PREGNANCY
    K993333 CLEARPLAN EASY II HOME PREGNANCY TEST
    K993141 AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
    K991369 ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
    K991193 SAS HCG-CHECK
    K990262 CLEARPLAN EASY HOME PREGNANCY TEST
    K990576 OSOM CARD PREGNANCY TEST, MODEL 103
    K990373 FACT PLUS ONE STEP PREGNANCY TEST
    K984075 INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
    K983090 ACON MIDSTREAM PREGNANCY TEST
    K981892 QUICK & SURE ONESTEP HOME PREGNANCY TEST
    K981722 QUIDEL HOME PREGNANCY TEST
    K974059 ONE STEP MIDSTREAM HCG PREGNANCY TEST
    K980532 QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
    K974821 BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
    K974154 CHOICE ACCU-TEST PREGNANCY TEST KIT
    K974021 SIGNAL PREGNANCY TEST KIT
    K973570 QUICK CARD HCG ONE STEP PREGNANCY TEST
    K973352 BRAND NAME *1-STEP PREGNANCY
    K973208 FIRST SIGN
    K972682 QUICKSTICK ONE STEP HCG PREGNANCY TEST
    K971286 EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
    K970425 EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
    K970008 ADVANCED QUALITY PREGNANCY TEST
    K965184 PERFECTA PREGNANCY TEST
    K970082 ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
    K963341 MIDSTREAM ONESTEP PREGNANCY HOME TEST
    K964108 FACT PLUS PREGNANCY TEST
    K964002 NATURALE HCG PREGNANCY TES
    K962721 EVIDENCE PREGNANCY TEST
    K962888 AFFIRM ONE-STEP HOME PREGNANCY TEST
    K962580 EZ SURE ONESTEP EARLY PREGNANCY TEST
    K962521 FACTPLUS ONE STEP PREGNANCY TEST
    K962219 QUICKSTICK ONE STEP PREGNANCY TEST(9010)
    K962183 BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
    K961965 SURE CHECK PREGNANCY TEST
    K961712 TBD AT-HOME PREGNANCY TEST
    K960733 MINISTICK PREGNANCY TEST
    K960316 CLEARBLUE EASY
    K960174 UNIMARK MIDSTREAM PREGNANCY TEST STICK
    K953606 BEST PREGNANCY TEST
    K960436 SELFCARE EARLY PREGNANCY TEST
    K960117 PLATFORM ONESTEP PREGNANCY HOME TEST
    K955903 SELFCARE EARLY PREGNANCY TEST
    K954178 OSOM PREGNANCY TEST
    K954364 CAMEO HOME PREGNANCY TEST
    K950354 HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY
    K945514 LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
    K945846 ADVANCE(R) PREGNANCY TEST
    K945568 HCG MIDSTREAM PREGNANCY TEST
    K941765 HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
    K941771 BODYWISE PREGNANCEY TEST
    K941355 PREGNANCY CHECK
    K940637 PREDICTOR HOME PREGNANCY TEST
    K933794 ANI BIOCARD(TM) HCG TEST
    K936013 EVATEST STRIP
    K934516 ADVANCE PREGNANCY TEST MODIFICATION
    K934830 HCG PREGNANCY ONE STEP TEST STRIP
    K931997 HCG MIDSTREAM PREGNANCY TEST
    K930488 BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
    K930640 PRECISE PREGNANCY
    K926308 LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
    K925189 PREGNAGEN 1-STEP PREGNANCY TEST
    K925096 CONCEIVE ONE-STEP PREGNANCY TEST
    K921099 SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
    K921012 PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
    K914990 ADVANCE(R) PREGNANCY TEST
    K914304 FIRST RESPONSE(R) ONE-STEP
    K914254 HOMECLINIC ONE STEP PREGNANCY TEST
    K912316 QUIKPAC-II ONE STEP PREGNANCY HOME TEST
    K911566 CLEARBLUE EASY
    K905742 CLEARBLUE EASY
    K904782 ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
    K901981 ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
    K896482 PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
    K895560 MODIFIED HOMECLINIC PREGNANCY TEST
    K884489 C&T PREGNANCY TEST KIT
    K883430 PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
    K883826 HOME CLINIC PREGNANCY TEST
    K882232 DISCOVER(R)
    K882588 BLUE DOT(TM) TEST FOR PREGNANCY
    K882416 CLEARBLUE EASY
    K880472 ADVANCE* AND DAISY* PREGNANCY TEST
    K874823 FIRST RESPONSE 5 MINUTE PREGNANCY TEST
    K880069 LEECO PREGNASTICK (EIA) CATALOG #003
    K874248 SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
    K871601 ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
    K871996 ABBOTT BIOTELL PREGNANCY TEST
    K863341 CARDS(TM) - EARLY PREGNANCY TEST
    K864373 CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
    K863999 VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
    K863841 TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
    K862207 QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
    K861946 PTK PLUS. HOME PREGNANCY TEST
    K861168 CLEARBLUE PREGNANCY TESTING KIT
    K860451 MUREX (TM), SUDS (TM), HCG ASSAY
    K860090 ANSWER PLUS AT HOME PREGNANCY TEST
    K853269 PREGNA/TEST
    K852274 ANSWER
    K850079 NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
    K844281 PTK HEALTHCHECK PREGNANCY TEST KIT
    K834474 H.P.T. HOME PREG. TEST KIT & A.P.T.
    K843238 ANSWER ONE-DAY
    K842265 ORTHO BRAND HOME PREGNANCY TEST
    K841415 BETA STICK, PREGNANCY TEST
    K841595 HEALTHCHECK HOME PREGNANCY TEST KIT
    K841602 ACCURATE BETA 30 PREGNANCY TEST KIT
    K834270 ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
    K840602 VERIFY PREGNANCY TEST KIT
    K832905 QUALITATIVE ENZYME IMMUNOASSAY-DETECT
    K832593 HOSPITAL LAB IN-HOME EARLY PREG TEST
    K833466 EARLY PREGNANCY DETECTION TEST KIT
    K831108 HOME PREGNANCY TEST KIT
    K831051 HOME PREGNANCY TEST KIT HPK #1
    K823109 GENERIC PREGNANCY TEST
    K822449 TPK 1980/1
    K813272 A-1 IN-HOME PREGNANCY TEST
    K780321 PREGNANCY TEST KIT, OVER-THE-COUNTER
    K780240 PREDICTOR
    K772359 PREGNANCY TEST KIT, ANSWER

    FEI Numbers

    This FDA classification entry is associated with 124 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 124 registration numbers. Click on an entry to view related FDA registrations.