Radioimmunoassay, Cocaine Metabolite
The Cocaine Metabolite Radioimmunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to detect and quantify cocaine metabolites (primarily benzoylecgonine) in urine or other biological specimens, used for drug screening and confirmation purposes. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLN and it is regulated under 21 CFR 862.3250 in the Clinical Toxicology specialty. This device is eligible for third-party review.
Research product code KLN in seconds
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Basic Information
- Product Code
- KLN
- Device Class
- FDA class 2
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | Nov 06, 2001 | Substantially Equivalent | Psychemedics Corp. |
| K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | Sep 19, 1991 | Substantially Equivalent | Immunalysis Corporation |
| K913722 | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE | Sep 10, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K912756 | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | Jul 26, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K910123 | TARGET COCAINE METABOLITE-V | Mar 19, 1991 | Substantially Equivalent | V-Tech, Inc. |
| K910122 | TARGET COCAINE METABOLITE-R | Mar 19, 1991 | Substantially Equivalent | V-Tech, Inc. |
| K910044 | MILENIA COCAINE METABOLITE | Feb 13, 1991 | Substantially Equivalent | Diagnostic Products Corp. |
| K905730 | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) | Jan 15, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K904995 | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE | Nov 28, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K880674 | MICROMEDIC CRACKPOT RIA KIT | Oct 06, 1988 | Substantially Equivalent | Icn Micromedic Systems |
| K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | Jun 16, 1987 | Substantially Equivalent | Immunalysis Corporation |
| K870740 | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 | Mar 19, 1987 | Substantially Equivalent | Diagnostic Products Corp. |
| K862218 | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT | Jun 27, 1986 | Substantially Equivalent | Diagnostic Products Corp. |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |