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/productcode/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](/device/K000257.md) | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | Diagnostic Products Corp. | Feb 23, 2000 | SESE |
| [K981573](/device/K981573.md) | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | United Biotech, Inc. | Sep 15, 1998 | SESE |
| [K964756](/device/K964756.md) | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | Wano-Tech Corp. | Apr 23, 1997 | SESE |
| [K931701](/device/K931701.md) | IMMULITE PAP | Diagnostic Products Corp. | Jan 27, 1994 | SESE |
| [K925377](/device/K925377.md) | IMX PAP | Abbott Laboratories | Jan 13, 1993 | SESE |
| [K921745](/device/K921745.md) | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | Jul 30, 1992 | SESE |
| [K902937](/device/K902937.md) | MILENIA PAP IRMA CATALOG #: MKPA1, X | Diagnostic Products Corp. | Sep 21, 1990 | SESE |
| [K901933](/device/K901933.md) | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | Diagnostic Products Corp. | Jun 28, 1990 | SESE |
| [K895723](/device/K895723.md) | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | Diagnostic Products Corp. | Oct 31, 1989 | SESE |
| [K893508](/device/K893508.md) | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | Baxter Healthcare Corp | Aug 4, 1989 | SESE |
| [K884748](/device/K884748.md) | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | Technicon Instruments Corp. | Jan 30, 1989 | SESE |
| [K873903](/device/K873903.md) | ABBOTT PAP-EIA | Abbott Laboratories | Dec 1, 1987 | SESE |
| [K864945](/device/K864945.md) | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Jan 5, 1987 | SESE |
| [K863832](/device/K863832.md) | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | Dec 16, 1986 | SESE |
| [K852845](/device/K852845.md) | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | Diagnostic Products Corp. | Sep 4, 1985 | SESE |
| [K851950](/device/K851950.md) | TANDEM E PAP | Hybritech, Inc. | Jun 25, 1985 | SESE |
| [K844679](/device/K844679.md) | DSL PAP RIA -DSL#3100 | Diagnostic Systems Laboratories, Inc. | Apr 29, 1985 | SESE |
| [K844968](/device/K844968.md) | EPICHROME PAP | Cetus Corp. | Feb 7, 1985 | SESE |
| [K843230](/device/K843230.md) | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | Ventrex Laboratories, Inc. | Sep 4, 1984 | SESE |
| [K831670](/device/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/productcode/JFH](https://fda.innolitics.com/productcode/JFH)

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