DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Clinical Toxicology · 21 CFR 862.3250 · Class 2
Overview
| Product Code | DIO |
|---|---|
| Device Name | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Classification Rationale
Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 145)
Showing 20 most recent of 145 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Carolina Liquid Chemistries Corp. | Jan 27, 2022 | SESE |
| K211973 | DRI Cocaine Metabolite Assay | Microgenics Corporation | Sep 24, 2021 | SESE |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | Mar 12, 2020 | SESE |
| K181499 | DRI Cocaine Metabolite Assay | Microgenics Corporation | Jul 6, 2018 | SESE |
| K170293 | Emit II Plus Cocaine Metabolite Assay | Siemens Healthcare Diagnostics, Inc. | Oct 25, 2017 | SESE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries Corporation | Aug 15, 2017 | SESE |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | Jun 2, 2017 | SESE |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | Nov 18, 2016 | SESE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | Guangzhou Wondfo Biotech Co., Ltd. | Jun 27, 2016 | SESE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | Safecare Biotech (Hangzhou) Co., Ltd. | Mar 18, 2016 | SESE |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | Biophor Diagnostics, Inc. | Jul 24, 2015 | SESE |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | Immunalysis Corporation | Jun 29, 2015 | SESE |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | Oct 7, 2014 | SESE |
| K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) | Healgen Scientific,, LLC | Jul 17, 2014 | SESE |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | Omega Laboratories, Inc. | Nov 13, 2013 | SESE |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | Guangzhou Wondfo Biotech Co., Ltd. | Jul 31, 2013 | SESE |
| K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | Guangzhou Wondfo Biotech Co., Ltd. | May 8, 2012 | SESE |
| K113751 | RANDOX COCAINE METABOLITE | Randox Laboratories, Ltd. | May 8, 2012 | SESE |
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | Branan Medical Corporation | Apr 11, 2012 | SESE |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | Phamatech, Inc. | Feb 1, 2012 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 9 clearances
- Syva Co. — 9 clearances
- Princeton BioMeditech Corp. — 7 clearances
- Abbott Laboratories — 6 clearances
- American Bio Medica Corp. — 4 clearances
