Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020) → JFH — Acid Phosphatase (Prostatic), Tartrate Inhibited # JFH · Acid Phosphatase (Prostatic), Tartrate Inhibited _Clinical Chemistry · 21 CFR 862.1020 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH ## Overview - **Product Code:** JFH - **Device Name:** Acid Phosphatase (Prostatic), Tartrate Inhibited - **Regulation:** [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Recent Cleared Devices (20 of 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K000257](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K000257.md) | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | Diagnostic Products Corp. | Feb 23, 2000 | SESE | | [K981573](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K981573.md) | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | United Biotech, Inc. | Sep 15, 1998 | SESE | | [K964756](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K964756.md) | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | Wano-Tech Corp. | Apr 23, 1997 | SESE | | [K931701](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K931701.md) | IMMULITE PAP | Diagnostic Products Corp. | Jan 27, 1994 | SESE | | [K925377](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K925377.md) | IMX PAP | Abbott Laboratories | Jan 13, 1993 | SESE | | [K921745](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K921745.md) | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | Jul 30, 1992 | SESE | | [K902937](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K902937.md) | MILENIA PAP IRMA CATALOG #: MKPA1, X | Diagnostic Products Corp. | Sep 21, 1990 | SESE | | [K901933](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K901933.md) | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | Diagnostic Products Corp. | Jun 28, 1990 | SESE | | [K895723](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K895723.md) | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | Diagnostic Products Corp. | Oct 31, 1989 | SESE | | [K893508](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K893508.md) | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | Baxter Healthcare Corp | Aug 4, 1989 | SESE | | [K884748](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K884748.md) | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | Technicon Instruments Corp. | Jan 30, 1989 | SESE | | [K873903](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K873903.md) | ABBOTT PAP-EIA | Abbott Laboratories | Dec 1, 1987 | SESE | | [K864945](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K864945.md) | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Jan 5, 1987 | SESE | | [K863832](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K863832.md) | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | Dec 16, 1986 | SESE | | [K852845](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K852845.md) | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | Diagnostic Products Corp. | Sep 4, 1985 | SESE | | [K851950](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K851950.md) | TANDEM E PAP | Hybritech, Inc. | Jun 25, 1985 | SESE | | [K844679](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K844679.md) | DSL PAP RIA -DSL#3100 | Diagnostic Systems Laboratories, Inc. | Apr 29, 1985 | SESE | | [K844968](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K844968.md) | EPICHROME PAP | Cetus Corp. | Feb 7, 1985 | SESE | | [K843230](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K843230.md) | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | Ventrex Laboratories, Inc. | Sep 4, 1984 | SESE | | [K831670](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH/K831670.md) | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | Ortho Diagnostic Systems, Inc. | Aug 24, 1983 | SESE | ## Top Applicants - Diagnostic Products Corp. — 6 clearances - Hybritech, Inc. — 4 clearances - Abbott Laboratories — 3 clearances - Biogenex Laboratories — 2 clearances - Leeco Diagnostics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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