FDA product code KLN: Radioimmunoassay, Cocaine Metabolite
KLN is the FDA product code for radioimmunoassay, cocaine metabolite. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 14 510(k) submissions under KLN, from 7 different applicants. The average 510(k) review took 64 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cocaine Metabolite |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KLN clearance
Top KLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 4 | 1991-09-10 |
| Diagnostic Products Corp. | 3 | 1991-02-13 |
| Immunalysis Corporation | 2 | 1991-09-19 |
| V-Tech, Inc. | 2 | 1991-03-19 |
| Psychemedics Corp. | 1 | 2001-11-06 |
2 more applicants have KLN clearances. See the full list in Caduvo.
Most recent KLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010868 | Psychemedics Corp. | PSYCHEMEDICS RIA COCAINE ASSAY | 2001-11-06 | 228 |
| K913867 | Immunalysis Corporation | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | 1991-09-19 | 23 |
| K913722 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE | 1991-09-10 | 25 |
| K912756 | Roche Diagnostic Systems, Inc. | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | 1991-07-26 | 35 |
| K910122 | V-Tech, Inc. | TARGET COCAINE METABOLITE-R | 1991-03-19 | 67 |
Recalls for KLN devices
openFDA lists no recalls for product code KLN.
Frequently asked questions
What is FDA product code KLN?
KLN is the FDA product code for radioimmunoassay, cocaine metabolite. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is KLN?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLN?
Across 14 cleared submissions the average was 64 days from receipt to decision (median 36).
Which companies have the most KLN clearances?
Roche Diagnostic Systems, Inc. (4); Diagnostic Products Corp. (3); Immunalysis Corporation (2); V-Tech, Inc. (2); Psychemedics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLN
- Run a recall and safety report across every KLN manufacturer
- Watch product code KLN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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