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: JLS FDA class 1

Radioimmunoassay, Progesterone

Clinical Chemistry

View full classification →

This device is a radioimmunoassay system used to measure progesterone levels in patient serum or plasma, used in assessing ovarian function, confirming ovulation, monitoring luteal phase adequacy, and evaluating early pregnancy or infertility. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JLS, regulated under 21 CFR 862.1620, within the Clinical Chemistry medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K040923

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA

Jul 22, 2004

Substantially Equivalent

IBL GMBH

K973898

PROGESTERONE ELISA

Nov 13, 1997

Substantially Equivalent

KMI DIAGNOSTICS, INC.

K972133

VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)

Jun 24, 1997

Substantially Equivalent

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

K971725

OPUS PROGESTERONE

Jun 18, 1997

Substantially Equivalent

BEHRING DIAGNOSTICS, INC.

K964841

ELECSYS PROGESTERONE ASSAY

Mar 24, 1997

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K965084

VIDAS PROESTERONE (PRG) (30 409)

Jan 09, 1997

Substantially Equivalent

BIOMERIEUX, INC.

K955025

AXSYM PROGESTERONE

Mar 07, 1996

Substantially Equivalent

ABBOTT LABORATORIES

K955769

ACCESS PROGESTERONE ASSAY

Feb 05, 1996

Substantially Equivalent

BIO-RAD LABORATORIES, INC.

K952075

PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM

Jun 13, 1995

Substantially Equivalent

BAYER CORP.

K951630

AURAFLEX PROGESTERONE 150TEST PACK

May 08, 1995

Substantially Equivalent

ORGANON TEKNIKA CORP.

K950570

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY

Apr 11, 1995

Substantially Equivalent

BAXTER DIAGNOSTICS, INC.

K944211

IMMULITE PROGESTERONE

Dec 19, 1994

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K935138

IMMULITE PROGESTERONE

Jan 11, 1994

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K933128

SYNELISA PROGESTERONE

Nov 05, 1993

Substantially Equivalent

ELIAS U.S.A., INC.

K933269

AIA-PACK(R) PROG ASSAY

Oct 22, 1993

Substantially Equivalent

TOSOH MEDICS, INC.

K931228

PROGESTERONE RADIOIMMUNOASSAY KIT

Oct 22, 1993

Substantially Equivalent

IMMUNOTECH CORP.

K933635

STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY

Oct 08, 1993

Substantially Equivalent

BAXTER DIAGNOSTICS, INC.

K932955

CIBA CORNING ACS PROGESTERONE IMMUNOASSAY

Aug 02, 1993

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K923410

FIAGEN PROGESTERONE

Dec 03, 1992

Substantially Equivalent

CYBERFLUOR, INC.

K920230

AFFINITY PRG

Feb 18, 1992

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K914462

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

Oct 23, 1991

Substantially Equivalent

SERONO-BAKER DIAGNOSTICS, INC.

K911512

MILENIA PROGESTERONE

May 22, 1991

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K910683

ENZYMUN-TEST PROGESTERONE

Apr 08, 1991

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K894049

IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT

Sep 08, 1989

Substantially Equivalent

PANTEX, DIV. BIO-ANALYSIS, INC.

K890836

RIA-GNOST PROGESTERONE

Mar 16, 1989

Substantially Equivalent

CAMBRIDGE MEDICAL TECHNOLOGY

K890428

DELFIA PROGESTERONE KIT

Feb 23, 1989

Substantially Equivalent

PHARMACIA, INC.

K884794

PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY

Feb 02, 1989

Substantially Equivalent

SERONO-BAKER DIAGNOSTICS, INC.

K884100

AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144

Nov 10, 1988

Substantially Equivalent

AMERSHAM CORP.

K880934

MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT

Apr 18, 1988

Substantially Equivalent

AMERSHAM CORP.

K873431

PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

Oct 20, 1987

Substantially Equivalent

SERONO DIAGNOSTICS, INC.

K871211

PROGESTERONE CLASP RADIOIMMUNOASSAY KIT

Apr 13, 1987

Substantially Equivalent

BIOTECX LABORATORIES, INC.

K864855

AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT

Feb 25, 1987

Substantially Equivalent

AMERSHAM CORP.

K864156

PROGESTERONE SYSTEM BY EIA

Nov 24, 1986

Substantially Equivalent

INTL. BIOCLINICAL, INC.

K860924

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT

Jul 02, 1986

Substantially Equivalent

MONOCLONAL ANTIBODIES, INC.

K854094

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

Feb 28, 1986

Substantially Equivalent

IMMUCHEM CORP.

K854675

DSL ANDROSTENEDIONE RIA (DSL #4200)

Jan 28, 1986

Substantially Equivalent

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

K854649

DSL PROGESTERONE RIA (DSL #3400)

Dec 13, 1985

Substantially Equivalent

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

K850056

LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT

Feb 06, 1985

Substantially Equivalent

LEECO DIAGNOSTICS, INC.

K845026

AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE

Feb 01, 1985

Substantially Equivalent

AMERSHAM CORP.

K841333

PROGESTERONE DIRECT RIA KIT-RADIOIMM

May 02, 1984

Substantially Equivalent

BIOTECX LABORATORIES, INC.

K840886

HYDROXYPROGESTERONE BY RIA 17A

Apr 18, 1984

Substantially Equivalent

RADIOASSAY SYSTEMS LABORATORIES, INC.

K832694

DIRIA-PROGK IMMUNOASSAY

Jan 11, 1984

Substantially Equivalent

SORIN BIOMEDICA, FIAT, USA, INC.

K832297

HYDROXYPROGESTERONE-17

Sep 01, 1983

Substantially Equivalent

DIAGNOSTICS BIOCHEM CANADA, INC.

K830880

IMMO PHASE DIRECT PROGESTERONE RADIO-

Apr 18, 1983

Substantially Equivalent

CORNING MEDICAL & SCIENTIFIC

K820686

LIQUISOL PROGESTERONE RADIOIMMUNO

Apr 01, 1982

Substantially Equivalent

DAMON CORP.

K820534

COAT-A-COUNT PROGESTERONE KIA KIT

Mar 16, 1982

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K813484

PROGESTERONE KIT BY RIA

Dec 22, 1981

Substantially Equivalent

IMMUCHEM CORP.

K811907

PROGESTERONE DIRECT RIA KIT (125I)

Jul 23, 1981

Substantially Equivalent

Immunalysis Corporation

K811369

NATAL-TEC PROGESTERONE

May 29, 1981

Substantially Equivalent

ARMKEL, LLC.

K810804

PROGESTERONE KIT

Apr 01, 1981

Substantially Equivalent

CAMBRIDGE NUCLEAR 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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