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: JFH FDA class 2

Acid Phosphatase (Prostatic), Tartrate Inhibited

Clinical Chemistry

View full classification →

Acid Phosphatase (Prostatic), Tartrate Inhibited is a clinical chemistry test system used to measure the activity of prostatic acid phosphatase in serum, historically used as a tumor marker for the detection and monitoring of prostate cancer. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JFH, regulated under 21 CFR 862.1020, within the Clinical Chemistry medical specialty. No special flags apply to this device.

510(k) Clearances

45 matches

K Number

Device Name

Decision Date

Decision

Applicant

K000257

IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

Feb 23, 2000

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K981573

UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

Sep 15, 1998

Substantially Equivalent

UNITED BIOTECH, INC.

K964756

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

Apr 23, 1997

Substantially Equivalent

WANO-TECH CORP.

K931701

IMMULITE PAP

Jan 27, 1994

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K925377

IMX PAP

Jan 13, 1993

Substantially Equivalent

ABBOTT LABORATORIES

K921745

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

Jul 30, 1992

Substantially Equivalent

HYBRITECH, INC.

K902937

MILENIA PAP IRMA CATALOG #: MKPA1, X

Sep 21, 1990

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K901933

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2

Jun 28, 1990

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K895723

IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)

Oct 31, 1989

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K893508

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI

Aug 04, 1989

Substantially Equivalent

BAXTER HEALTHCARE CORP.

K884748

TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)

Jan 30, 1989

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K873903

ABBOTT PAP-EIA

Dec 01, 1987

Substantially Equivalent

ABBOTT LABORATORIES

K864945

TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY

Jan 05, 1987

Substantially Equivalent

HYBRITECH, INC.

K863832

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE

Dec 16, 1986

Substantially Equivalent

POINTE SCIENTIFIC, INC.

K852845

PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY

Sep 04, 1985

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K851950

TANDEM E PAP

Jun 25, 1985

Substantially Equivalent

HYBRITECH, INC.

K844679

DSL PAP RIA -DSL#3100

Apr 29, 1985

Substantially Equivalent

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

K844968

EPICHROME PAP

Feb 07, 1985

Substantially Equivalent

CETUS CORP.

K843230

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC

Sep 04, 1984

Substantially Equivalent

VENTREX LABORATORIES, INC.

K831670

ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO

Aug 24, 1983

Substantially Equivalent

ORTHO DIAGNOSTIC SYSTEMS, INC.

K831105

CORDIA PAP

May 16, 1983

Substantially Equivalent

CORDIS CORP.

K822298

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI

Sep 02, 1982

Substantially Equivalent

NUCLEAR MEDICAL LABORATORIES, INC.

K820724

FLUOROGEN PAP FIA

Apr 14, 1982

Substantially Equivalent

BIOGENEX LABORATORIES

K812925

ABBOTT PAP-EIA

Jan 19, 1982

Substantially Equivalent

ABBOTT LABORATORIES

K813261

RIAGEN PAP RIA

Dec 17, 1981

Substantially Equivalent

BIOGENEX LABORATORIES

K811959

TANDEM PAP KIT - (PARTS I & II)

Sep 01, 1981

Substantially Equivalent

HYBRITECH, INC.

K811757

NEIA PAP ENZYMEIMMUNOASSAY

Aug 13, 1981

Substantially Equivalent

NEW ENGLAND IMMUNOLOGY ASSOC.

K811274

PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT

May 27, 1981

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K811169

PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT

May 15, 1981

Substantially Equivalent

AMERSHAM CORP.

K803234

ESKACHEM PAP REAGENT

Feb 26, 1981

Substantially Equivalent

SMITH KLINE DIAGNOSTICS, INC.

K810232

LEECO P.A.P. - QUANT DIAGNOSTIC KIT

Feb 10, 1981

Substantially Equivalent

LEECO DIAGNOSTICS, INC.

K802886

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-

Jan 28, 1981

Substantially Equivalent

NUCLEAR DIAGNOSTICS, INC.

K803043

RIAPHASE (125I) PROST. ACID PHOSPH. KIT

Jan 02, 1981

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K802153

CBC PAP TEST KIT

Nov 12, 1980

Substantially Equivalent

CALBIOCHEM-BEHRING CORP.

K801988

NORDICLAB PROSTATIC ACID PHOSPHATASE RIA

Sep 26, 1980

Substantially Equivalent

NORDICLAB INTL.

K792652

LEECO P.A.P. QUANT. DIAGNOSTIC KIT

Jan 16, 1980

Substantially Equivalent

LEECO DIAGNOSTICS, INC.

K792059

S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO

Dec 13, 1979

Substantially Equivalent

S.F. BIOLOGICALS, INC.

K792405

ELVI ACID & PROSTATIC PHOSPHATASE

Dec 07, 1979

Substantially Equivalent

VOLU SOL MEDICAL INDUSTRIES

K791497

PROSTATIC ACID RADIOIMMUNOASSAY TEST

Dec 04, 1979

Substantially Equivalent

CLINICAL ASSAYS, INC.

K791735

PAP RIA KIT

Nov 15, 1979

Substantially Equivalent

NUCLEAR MEDICAL SYSTEMS, INC.

K792043

PAP-CHECK RIA KIT

Oct 30, 1979

Substantially Equivalent

SERONO LABORATORIES, INC.

K790580

RIA KIT, PROSTATIC ACID

May 25, 1979

Substantially Equivalent

MONITOR SCIENCE CORP.

K790317

PAP RIA KIT

May 07, 1979

Substantially Equivalent

YANG LABORATORIES, INC.

K790817

RIA KIT, QUANTITATION OF PROSTATIC ACID

May 07, 1979

Substantially Equivalent

NEW ENGLAND NUCLEAR

K790040

P.A.P. TEST KIT, RIA-ZYME

Apr 17, 1979

Substantially Equivalent

MALLINCKRODT CRITICAL CARE

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