FDA product code LAF: Gas Chromatography, Methamphetamine
LAF is the FDA product code for gas chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel. FDA has cleared 49 510(k) submissions under LAF, from 32 different applicants. The average 510(k) review took 148 days (median 89). FDA has posted 1 recall for LAF devices.
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Methamphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3610 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LAF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 202 |
| 2020 | 1 | 60 |
| 2021 | 2 | 348 |
Compare with all 510(k) review times · Search every LAF clearance
Top LAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phamatech | 4 | 2001-04-11 |
| Immunalysis Corporation | 3 | 2021-12-22 |
| Lin-Zhi International, Inc. | 3 | 2014-03-21 |
| Microgenics Corp. | 3 | 2011-04-08 |
| ACON Laboratories, Inc. | 3 | 2003-12-12 |
27 more applicants have LAF clearances. See the full list in Caduvo.
Most recent LAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203647 | Immunalysis Corporation | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | 2021-12-22 | 373 |
| K210212 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | 2021-12-15 | 322 |
| K201442 | Diatron Group | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | 2020-07-31 | 60 |
| K170222 | American Bio Medica Corp. | Rapid Tox Cup II | 2017-08-15 | 202 |
| K153693 | Immunalysis Corporation | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 2016-03-18 | 86 |
Recalls for LAF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code LAF?
LAF is the FDA product code for gas chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel.
What device class is LAF?
Class II, regulation 21 CFR 862.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAF?
Across 49 cleared submissions the average was 148 days from receipt to decision (median 89).
Which companies have the most LAF clearances?
Phamatech (4); Immunalysis Corporation (3); Lin-Zhi International, Inc. (3); Microgenics Corp. (3); ACON Laboratories, Inc. (3).
Have LAF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LAF
- Run a recall and safety report across every LAF manufacturer
- Watch product code LAF 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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