FDA product code KLT: Enzyme Immunoassay, Carbamazepine
KLT is the FDA product code for enzyme immunoassay, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. FDA has cleared 56 510(k) submissions under KLT, from 34 different applicants. The average 510(k) review took 82 days (median 54). FDA has posted 5 recalls for KLT devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Carbamazepine |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| 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 KLT clearance
Top KLT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 12 | 2000-01-27 |
| Abbott Laboratories | 5 | 2011-10-14 |
| Beckman Instruments, Inc. | 3 | 1997-02-04 |
| Miles Laboratories, Inc. | 3 | 1987-01-14 |
| Bayer Corp. | 2 | 2000-05-18 |
29 more applicants have KLT clearances. See the full list in Caduvo.
Most recent KLT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151578 | Roche Diagnostics Operations (Rdo) | Carbamazepine Gen 4 | 2015-10-22 | 133 |
| K123518 | Microgenics Corporation | ABBOTT CARBAMAZEPINE ASSAY | 2013-06-05 | 203 |
| K103627 | Abbott Laboratories | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS | 2011-10-14 | 305 |
| K063131 | Thermo Electron OY | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | 2007-10-05 | 357 |
| K042808 | Bayer Healthcare, LLC | ADVIA IMS CARBAMAZEPINE METHOD | 2005-02-08 | 119 |
Recalls for KLT devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-05.
Frequently asked questions
What is FDA product code KLT?
KLT is the FDA product code for enzyme immunoassay, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is KLT?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLT?
Across 56 cleared submissions the average was 82 days from receipt to decision (median 54).
Which companies have the most KLT clearances?
Syva Co. (12); Abbott Laboratories (5); Beckman Instruments, Inc. (3); Miles Laboratories, Inc. (3); Bayer Corp. (2).
Have KLT devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2014-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KLT
- Run a recall and safety report across every KLT manufacturer
- Watch product code KLT 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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