Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: JIS FDA class 2

Calibrator, Primary

Clinical Chemistry

View full classification →

This device is a primary calibrator used in clinical chemistry laboratory analyzers to establish an accurate reference baseline for quantitative test measurements, ensuring that analytical instruments produce results traceable to accepted reference standards. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. The product code is JIS, regulated under 21 CFR 862.1150, and belongs to the Clinical Chemistry medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K122126

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

Aug 14, 2012

Substantially Equivalent

RANDOX LABORATORIES LIMITED

K061251

DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

May 31, 2006

Substantially Equivalent

DADE BEHRING, INC.

K060266

DIMENSION IRON CALIBRATOR

Mar 09, 2006

Substantially Equivalent

DADE BEHRING, INC.

K053104

DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

Dec 23, 2005

Substantially Equivalent

DADE BEHRING, INC.

K032697

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

Nov 07, 2003

Substantially Equivalent

DADE BEHRING, INC.

K032608

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

Oct 21, 2003

Substantially Equivalent

GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB

K032296

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS

Aug 13, 2003

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

K030964

CALIBRATION PLASMA LMW HEPARIN

Jun 06, 2003

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K030546

CRP (II) CALIBRATORS

Jun 02, 2003

Substantially Equivalent

DENKA SEIKEN CO., LTD.

K030320

WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET

Apr 11, 2003

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K022682

RANDOX C-REACTIVE PROTEIN CALIBRATOR

Nov 05, 2002

Substantially Equivalent

RANDOX LABORATORIES, LTD.

K022901

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS

Sep 27, 2002

Substantially Equivalent

ORTHO-CLINICAL DIAGNOSTICS

K013126

N LP(A) STANDARD SY

Nov 09, 2001

Substantially Equivalent

DADE BEHRING, INC.

K012878

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609

Oct 16, 2001

Substantially Equivalent

THERMO DMA, INC.

K011568

RANDOX LIPOPROTEIN

Sep 28, 2001

Substantially Equivalent

RANDOX LABORATORIES, LTD.

K010696

BECKMAN COULTER DNASE B CALIBRATOR

May 10, 2001

Substantially Equivalent

BECKMAN COULTER, INC.

K003941

ELECSYS HCG STAT CLASET II

Jan 25, 2001

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K003969

ELECSYS CA 125 II CALSET

Jan 12, 2001

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K002760

ELECSYS DHEA-S CALSET

Oct 05, 2000

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K002353

ELECSYS CA 15-3 CALCHECK

Aug 10, 2000

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K001906

ELECSYS INSULIN CALSET

Jul 13, 2000

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K001004

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

Jun 01, 2000

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K001005

WAKO HDL-C/LDL-C CALIBRATOR

Jun 01, 2000

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K001002

WAKO LIPASE CALIBRATOR

May 24, 2000

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K000331

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

Feb 10, 2000

Substantially Equivalent

BECKMAN COULTER, INC.

K994168

SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR

Feb 03, 2000

Substantially Equivalent

BECKMAN COULTER, INC.

K994169

SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR

Feb 03, 2000

Substantially Equivalent

BECKMAN COULTER, INC.

K994114

DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

Jan 20, 2000

Substantially Equivalent

DADE BEHRING, INC.

K994325

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

Jan 12, 2000

Substantially Equivalent

BECKMAN COULTER, INC.

K994145

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS

Dec 22, 1999

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

K993219

WAKO BILIRUBIN CALIBRATOR

Nov 09, 1999

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K983640

SYNCHRON SYSTEMS LIPID CALIBRATOR

Dec 21, 1998

Substantially Equivalent

BECKMAN COULTER, INC.

K970933

AUTO HDL CHOLESTEROL CALIBRATOR

May 23, 1997

Substantially Equivalent

POINTE SCIENTIFIC, INC.

K963847

WAKO DIRECT HDL-C

Dec 24, 1996

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K964475

CLINICAL BLOOD GAS MIXTURES

Dec 06, 1996

Substantially Equivalent

OXARC, INC.

K954546

BLOOD GAS MIXTURE

Dec 28, 1995

Substantially Equivalent

LIQUID TECHNOLOGY CORP.

K951964

SYNCHRON ENZYME VALIDATOR SET

Jun 29, 1995

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K951585

T-UPTAKE CALIBRATORS

Jun 15, 1995

Substantially Equivalent

DIAGNOSTIC REAGENTS, INC.

K951629

IMX ESTRADIOL

May 17, 1995

Substantially Equivalent

ABBOTT LABORATORIES

K944701

CALIBRATORS

Nov 21, 1994

Substantially Equivalent

DIAGNOSTIC REAGENTS, INC.

K940008

GLYCATED PROTEIN CALIBRATORS

May 09, 1994

Substantially Equivalent

PRIMUS CORP.

K936201

URINARY ALBUMIN CALIBRATOR

Mar 11, 1994

Substantially Equivalent

DUPONT MEDICAL PRODUCTS

K931834

KING SODIUM/POTASSIUM STANDARD MODIFIED

Aug 25, 1993

Substantially Equivalent

KING DIAGNOSTICS, INC.

K932555

DC-LINEATE CAT. NO. SE-091

Aug 19, 1993

Substantially Equivalent

DIAGNOSTIC CHEMICALS, LTD. (USA)

K930501

DU PONT ACA NEV/EEV VERIFIER

Aug 09, 1993

Substantially Equivalent

DUPONT MEDICAL PRODUCTS

K922646

REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM

Jun 25, 1993

Substantially Equivalent

BEHRING DIAGNOSTICS, INC.

K930477

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR

Jun 07, 1993

Substantially Equivalent

ANALYTICAL CONTROL SYSTEMS, INC.

K925877

DC-UIBC-CAL

Mar 18, 1993

Substantially Equivalent

DIAGNOSTIC CHEMICALS, LTD. (USA)

K924904

HDL-CHOLESTEROL STANDARD, MODIFICATION

Jan 13, 1993

Substantially Equivalent

VERICHEM LABORATORIES, INC.

K922699

DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR

Sep 23, 1992

Substantially Equivalent

E.I. DUPONT DE NEMOURS & CO., INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump