Radioimmunoassay, Barbiturate
The Radioimmunoassay for Barbiturate is a quantitative laboratory test using radiolabeled reagents and antibody-based methodology to detect and measure barbiturate compounds in biological specimens, supporting emergency toxicology screening and therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3150 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.
Basic Information
- Product Code
- DKN
- Device Class
- FDA class 2
- Regulation Number
- 862.3150
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914468 | ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES | Oct 30, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K881816 | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES | Jul 28, 1988 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Mar 10, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | Dec 31, 1981 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.