Product Code: JFH FDA class 2 21 CFR 862.1020

Acid Phosphatase (Prostatic), Tartrate Inhibited

Clinical Chemistry

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.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JFH
Device Class: FDA class 2
Regulation Number: 862.1020
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

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	Smithkline 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.
K790817	RIA KIT, QUANTITATION OF PROSTATIC ACID	May 07, 1979	Substantially Equivalent	New England Nuclear
K790317	PAP RIA KIT	May 07, 1979	Substantially Equivalent	Yang Laboratories, Inc.
K790040	P.A.P. TEST KIT, RIA-ZYME	Apr 17, 1979	Substantially Equivalent	Mallinckrodt Critical Care