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) → CKB — Acid Phosphatase, Naphthyl Phosphate # CKB · Acid Phosphatase, Naphthyl Phosphate _Clinical Chemistry · 21 CFR 862.1020 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB ## Overview - **Product Code:** CKB - **Device Name:** Acid Phosphatase, Naphthyl Phosphate - **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 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K053612](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K053612.md) | DRI-STAT ACID PHOSPHATASE REAGENT | Beckman Coulter, Inc. | Apr 26, 2006 | SESE | | [K023840](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K023840.md) | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | Jan 7, 2003 | SESE | | [K991010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K991010.md) | ACP | Abbott Diagnostics Mfg., Inc. | May 19, 1999 | SESE | | [K981743](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K981743.md) | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Jun 9, 1998 | SESE | | [K974695](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K974695.md) | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | Roche Diagnostic Systems, Inc. | May 21, 1998 | SESE | | [K963640](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K963640.md) | OLYMPUS ACID PHOSPHATASE REAGENT | Olympus America, Inc. | Feb 18, 1997 | SESE | | [K943366](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K943366.md) | IL TEST ACID PHOSPHATASE | Instrumentation Laboratory CO | Jan 29, 1996 | SESE | | [K902543](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K902543.md) | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | Sep 7, 1990 | SESE | | [K902495](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K902495.md) | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | Jul 16, 1990 | SESE | | [K892393](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K892393.md) | ACID PHOSPHATASE REAGENT | Medical Analysis Systems, Inc. | Jul 20, 1989 | SESE | | [K884747](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K884747.md) | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | Technicon Instruments Corp. | Jan 30, 1989 | SESE | | [K881204](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K881204.md) | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | Sclavo, Inc. | Apr 28, 1988 | SESE | | [K880798](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K880798.md) | ACID PHOSPHATASE REAGENT | Trace America, Inc. | Apr 18, 1988 | SESE | | [K875209](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K875209.md) | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | Feb 1, 1988 | SESE | | [K863851](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K863851.md) | ACID PHOSPHATASE (ACP) REAGENT | Sigma Diagnostics, Inc. | Oct 16, 1986 | SESE | | [K861675](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K861675.md) | ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE | | [K854223](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K854223.md) | VES-TEC/VES-MATIC | Marvic Interpharma, Inc. | Apr 4, 1986 | SESE | | [K853949](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K853949.md) | DEMAND ACID PHOSPHATASE REAGENT | Cooper Biomedical, Inc. | Oct 16, 1985 | SESE | | [K850902](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K850902.md) | DATA ZYME ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | Mar 20, 1985 | SESE | | [K840661](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB/K840661.md) | PARAMAX ACID PHOSPHATASE REAGENT | American Dade | Apr 4, 1984 | SESE | ## Top Applicants - Data Medical Associates, Inc. — 2 clearances - Olympus America, Inc. — 2 clearances - Abbott Diagnostics Mfg., Inc. — 1 clearance - American Dade — 1 clearance - Bayer Diagnostics Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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