Anti-Sm Antibody, Antigen And Control
Anti-Sm Antibody, Antigen and Control is a diagnostic immunoassay system used to detect antibodies against the Smith (Sm) antigen, a nuclear antigen that is highly specific for systemic lupus erythematosus (SLE) and is used as a confirmatory marker for that condition. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKP, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
Research product code LKP in seconds
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Basic Information
- Product Code
- LKP
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 28 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202067 | EliA SmDP-S | Jul 14, 2021 | Substantially Equivalent | Phadia AB |
| K183007 | EliA SmDP Immunoassay | Dec 24, 2018 | Substantially Equivalent | Phadia AB |
| K132631 | EIA SMDP IMMUNOASSAY | Aug 29, 2014 | Substantially Equivalent | Phadia US, Inc. |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | Apr 17, 2013 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K051066 | THERATEST EL-ANA PROFILES | Oct 07, 2005 | Substantially Equivalent | Theratest Laboratories, Inc. |
| K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | Dec 08, 2004 | Substantially Equivalent | Sweden Diagnostics (Germany) GmbH |
| K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | Jan 15, 2003 | Substantially Equivalent | Bio-Rad |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | Jul 29, 2002 | Substantially Equivalent | Fred Hutchinson Cancer Research Center |
| K000755 | RHIGENE MESACUP2 TEST- SM | May 09, 2000 | Substantially Equivalent | Rhigene, Inc. |
| K000312 | VARELISA SM ANTIBODIES | Mar 17, 2000 | Substantially Equivalent | Pharmacia & Upjohn Co. |
| K990625 | AUTOSTAT II ANTI-SM ELISA | Apr 28, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | Dec 22, 1998 | Substantially Equivalent | Bio-Rad |
| K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K980540 | SERAQUEST ANTI-SM | Jun 15, 1998 | Substantially Equivalent | Quest Intl., Inc. |
| K980811 | SERAQUEST ANTI-SM/RNP | May 12, 1998 | Substantially Equivalent | Quest Intl., Inc. |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | May 08, 1996 | Substantially Equivalent | Orgentec |
| K954896 | HYTEC AUTOIMMUNE KITS (SM) | Mar 22, 1996 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | Apr 20, 1994 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K930141 | SYNELISA SM ABS/RNP-SM ABS | May 11, 1993 | Substantially Equivalent | Elias U.S.A., Inc. |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | May 07, 1991 | Substantially Equivalent | General Biometrics, Inc. |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | May 07, 1991 | Substantially Equivalent | General Biometrics, Inc. |
| K905192 | DIASTAT ANTI-SM/RNP | Dec 07, 1990 | Substantially Equivalent | Shield Diagnostics, Ltd. |
| K905191 | DIASTAT ANTI-SM | Dec 07, 1990 | Substantially Equivalent | Shield Diagnostics, Ltd. |
| K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES | Nov 06, 1989 | Substantially Equivalent | Lipogen, Inc. |
| K881379 | WESBLOT RNP-SM TEST | May 16, 1988 | Substantially Equivalent | American Bionetics, Inc. |
| K880254 | SM ANTIBODY TEST KIT | Apr 06, 1988 | Substantially Equivalent | Lipogen, Inc. |
| K873741 | IMMUSTRIP(TM) SM ELISA TEST SYSTEM | Nov 04, 1987 | Substantially Equivalent | Immunomedics, Inc. |
| K841930 | ENZYMATIC ACETAMINOPHEN ASSAY | Jun 25, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.