Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3030](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3030) → LDP — Colorimetry, Acetaminophen # LDP · Colorimetry, Acetaminophen _Clinical Toxicology · 21 CFR 862.3030 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP ## Overview - **Product Code:** LDP - **Device Name:** Colorimetry, Acetaminophen - **Regulation:** [21 CFR 862.3030](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3030) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) - **3rd-party reviewable:** yes ## Identification An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K202644](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K202644.md) | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | Feb 18, 2022 | SESE | | [K180835](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K180835.md) | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | Feb 8, 2019 | SESE | | [K110726](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K110726.md) | ROCHE ACETAMINOPHEN ASSAY | Roche Diagnostics | Dec 23, 2011 | SESE | | [K100200](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K100200.md) | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | Aug 2, 2010 | SESE | | [K081938](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K081938.md) | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | May 1, 2009 | SESE | | [K061655](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K061655.md) | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | Jul 10, 2006 | SESE | | [K043242](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K043242.md) | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | Feb 28, 2005 | SESE | | [K042330](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K042330.md) | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | Jan 7, 2005 | SESE | | [K020792](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K020792.md) | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Jul 11, 2002 | SESE | | [K013757](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K013757.md) | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | Jan 8, 2002 | SESE | | [K011465](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K011465.md) | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | Beckman Coulter, Inc. | Jun 8, 2001 | SESE | | [K002974](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K002974.md) | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | Oct 11, 2000 | SESE | | [K000494](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K000494.md) | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | Apr 14, 2000 | SESE | | [K991598](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K991598.md) | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | Jul 22, 1999 | SESE | | [K981059](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K981059.md) | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | May 12, 1998 | SESE | | [K980031](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K980031.md) | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | Mar 3, 1998 | SESE | | [K963244](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K963244.md) | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 23, 1996 | SESE | | [K961373](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K961373.md) | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | Jul 8, 1996 | SESE | | [K954933](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K954933.md) | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | Dec 18, 1995 | SESE | | [K952949](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K952949.md) | ACETAMINOPHEN ASSAY | Diagnostic Chemicals , Ltd. | Sep 6, 1995 | SESE | ## Top Applicants - Diagnostic Chemicals , Ltd. — 4 clearances - Abbott Laboratories — 2 clearances - Beckman Coulter, Inc. — 2 clearances - Dade Behring, Inc. — 2 clearances - Roche Diagnostics Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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