LDP · Colorimetry, Acetaminophen
Clinical Toxicology · 21 CFR 862.3030 · Class 2
Overview
| Product Code | LDP |
|---|---|
| Device Name | Colorimetry, Acetaminophen |
| Regulation | 21 CFR 862.3030 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 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 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | Feb 18, 2022 | SESE |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | Feb 8, 2019 | SESE |
| K110726 | ROCHE ACETAMINOPHEN ASSAY | Roche Diagnostics | Dec 23, 2011 | SESE |
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | Aug 2, 2010 | SESE |
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | May 1, 2009 | SESE |
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | Jul 10, 2006 | SESE |
| K043242 | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | Feb 28, 2005 | SESE |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | Jan 7, 2005 | SESE |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Jul 11, 2002 | SESE |
| K013757 | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | Jan 8, 2002 | SESE |
| K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | Beckman Coulter, Inc. | Jun 8, 2001 | SESE |
| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | Oct 11, 2000 | SESE |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | Apr 14, 2000 | SESE |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | Jul 22, 1999 | SESE |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | May 12, 1998 | SESE |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | Mar 3, 1998 | SESE |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 23, 1996 | SESE |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | Jul 8, 1996 | SESE |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | Dec 18, 1995 | SESE |
| K952949 | 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
