FDA product code LAS: Drug Specific Control Materials
LAS is the FDA product code for drug specific control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 83 510(k) submissions under LAS, from 27 different applicants. The average 510(k) review took 61 days (median 39). FDA has posted 1 recall for LAS devices.
Classification
| Field | Value |
|---|---|
| Device name | Drug Specific Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Top LAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 22 | 1984-10-05 |
| Roche Diagnostic Systems, Inc. | 14 | 1995-02-07 |
| Utak Laboratories, Inc. | 8 | 1991-04-12 |
| Hemometrix | 6 | 1979-12-18 |
| Microgenics Corp. | 5 | 2005-06-06 |
22 more applicants have LAS clearances. See the full list in Caduvo.
Most recent LAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080459 | Chromsystems Instruments & Chemicals GmbH | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS | 2009-11-17 | 636 |
| K072257 | More Diagnostics | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | 2008-01-30 | 170 |
| K062942 | Quantimetrix Corp. | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | 2006-10-30 | 32 |
| K051074 | Microgenics Corp. | MAS IMMUNOSUPPRESSANT CONTROLS | 2005-06-06 | 40 |
| K040411 | Microgenics Corp. | DRI OXYCODONE ASSAY | 2004-05-27 | 99 |
Recalls for LAS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-03.
Frequently asked questions
What is FDA product code LAS?
LAS is the FDA product code for drug specific control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is LAS?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LAS?
Across 83 cleared submissions the average was 61 days from receipt to decision (median 39).
Which companies have the most LAS clearances?
Syva Co. (22); Roche Diagnostic Systems, Inc. (14); Utak Laboratories, Inc. (8); Hemometrix (6); Microgenics Corp. (5).
Have LAS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-10-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LAS
- Run a recall and safety report across every LAS manufacturer
- Watch product code LAS 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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