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: CDX FDA class 2

Radioimmunoassay, Total Thyroxine

Clinical Chemistry

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The Total Thyroxine Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody competition to measure total thyroxine (T4) levels in serum, providing essential data for diagnosing and monitoring thyroid function disorders including hypothyroidism and hyperthyroidism. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CDX, regulated under 21 CFR 862.1700, within the Clinical Chemistry medical specialty. No special flags apply to this device.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K961490

ELECSYS T4 ASSAY

Jun 13, 1996

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K954312

ACTIVE THYROXINE RIA

Oct 07, 1995

Substantially Equivalent

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

K943416

DELFIA NEONATAL THYROXINE KIT

Mar 10, 1995

Substantially Equivalent

WALLAC OY

K934384

AXSYM(TM) TOTAL T4

Jun 21, 1994

Substantially Equivalent

ABBOTT LABORATORIES

K932980

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

Oct 18, 1993

Substantially Equivalent

SIGMA DIAGNOSTICS, INC.

K933426

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

Aug 26, 1993

Substantially Equivalent

BAXTER DIAGNOSTICS, INC.

K931295

IQ TT4 ASSAY

Jul 20, 1993

Substantially Equivalent

BECTON DICKINSON ADVANCED DIAGNOSTICS

K926563

AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT

Mar 18, 1993

Substantially Equivalent

BIO-CHEM LABORATORY SYSTEMS, INC.

K925110

ABBOTT IMX T4

Jan 26, 1993

Substantially Equivalent

ABBOTT LABORATORIES

K925109

ABBOTT TDX/TDXFLX TT4

Jan 04, 1993

Substantially Equivalent

ABBOTT LABORATORIES

K922945

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

Oct 14, 1992

Substantially Equivalent

HERAEUS KULZER, INC.

K921935

THYROXINE (T4) COATED TUBE RIA

Jul 07, 1992

Substantially Equivalent

MONOBIND

K920766

T4 EIA BEAD ASSAY

Apr 17, 1992

Substantially Equivalent

TECH-CO, INC.

K915235

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT

Jan 28, 1992

Substantially Equivalent

INCSTAR CORP.

K912541

MILENIA TOTAL T4, CATALOG: MKT41,5

Aug 12, 1991

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K911985

LUMATAG T4 CHEMILUMINESCENCE ASSAY

Aug 02, 1991

Substantially Equivalent

LONDON DIAGNOSTICS, INC.

K904816

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM

Jan 17, 1991

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K905532

CIBA CORNING ACS T4 IMMUNOASSAY

Jan 15, 1991

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K902922

MICROZYME T4 ENZYME IMMUNOASSAY KIT

Jul 27, 1990

Substantially Equivalent

IMMUNOTECH CORP.

K901475

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4

Jun 20, 1990

Substantially Equivalent

BAXTER HEALTHCARE CORP.

K901939

NEOCOAT T4

May 31, 1990

Substantially Equivalent

NEOMETRICS, INC.

K894575

TECHNICON RA SYSTEM THYROXINE T4 METHOD

Oct 04, 1989

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K883559

DELFIA THYROXINE (T4) KIT

Dec 14, 1988

Substantially Equivalent

PHARMACIA, INC.

K874623

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101

Feb 16, 1988

Substantially Equivalent

CYBERFLUOR, INC.

K875081

IMMPULSE T4 ASSAY REAGENTS

Feb 11, 1988

Substantially Equivalent

SCLAVO, INC.

K872286

CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY

Jul 21, 1987

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K871303

DELFIA(TM) THYROXINE (T4) KIT

Jun 17, 1987

Substantially Equivalent

LKB INSTRUMENTS, INC.

K871008

MICROMEDIC NEONATAL T4 KIT

May 26, 1987

Substantially Equivalent

MICROMEDIC SYSTEMS

K870965

CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY

May 14, 1987

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K870573

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT

Apr 22, 1987

Substantially Equivalent

CAMBRIDGE MEDICAL TECHNOLOGY

K864560

IQ T4 IMMUNOASSAY

Dec 16, 1986

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K861320

MMS T4 RIA KIT

Apr 24, 1986

Substantially Equivalent

MICROMEDIC SYSTEMS

K860421

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

Feb 11, 1986

Substantially Equivalent

AMERICAN DADE

K854798

T-4 RIASSAY

Jan 15, 1986

Substantially Equivalent

RIA DIAGNOSTICS

K854324

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

Dec 05, 1985

Substantially Equivalent

PANTEX, DIV. BIO-ANALYSIS, INC.

K840852

IMMPULSE T4 ASSAY REAGENTS

Apr 18, 1984

Substantially Equivalent

PARAGON DIAGNOSTICS, INC.

K834023

BIO-SCIENCE LABORATORIES T4 REAGENT

Jan 24, 1984

Substantially Equivalent

BIOSAN LABORATORIES, INC.

K833850

T4 RIA

Jan 18, 1984

Substantially Equivalent

SYNCOR INTL. CORP.

K833745

RIACOAT T-4

Jan 04, 1984

Substantially Equivalent

IMMUNO ASSAY CORP.

K832468

T4-RIA SINGLE REAGENT

Sep 12, 1983

Substantially Equivalent

FAIRLAKE LABORATORIES

K831533

MAGIC T4 125I RADIOIMMUNOASSAY

Jun 30, 1983

Substantially Equivalent

CORNING MEDICAL & SCIENTIFIC

K831107

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

May 18, 1983

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K830642

PHASE THYROXINE RADIOIMMUNOASSAY KIT

Apr 05, 1983

Substantially Equivalent

MEDICAL & SCIENTIFIC DESIGNS, INC.

K823265

MONOCLONAL ANTIBODY T4 RADIO-KIT

Dec 09, 1982

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K823053

NML-TETRA-TUBE RIA

Nov 10, 1982

Substantially Equivalent

NUCLEAR MEDICAL LABORATORIES, INC.

K823004

BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT

Nov 05, 1982

Substantially Equivalent

BIOCLINICAL GROUP

K822399

LEECO T4 QUANT DIAGNOSTICS TEST KIT

Sep 13, 1982

Substantially Equivalent

LEECO DIAGNOSTICS, INC.

K821554

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

Jun 25, 1982

Substantially Equivalent

AMF BIOLOGICAL AND DIAGNOSTICS CO.

K820725

SPAC T4 RIA TEST KIT

Jun 01, 1982

Substantially Equivalent

MALLINCKRODT CRITICAL CARE

K821141

ENDAB T4 ENZYME IMMUNOASSAY KIT

May 13, 1982

Substantially Equivalent

IMMUNOTECH CORP.

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.

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