FDA product code LAO: Enzyme Immunoassay, Methotrexate
LAO is the FDA product code for enzyme immunoassay, methotrexate. It is a Unclassified device, reviewed by the Clinical Toxicology panel. FDA has cleared 10 510(k) submissions under LAO, 2 in the last five years, from 6 different applicants. The average 510(k) review took 95 days (median 72); 123 days on average over the last three years. FDA has posted 2 recalls for LAO devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Methotrexate |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LAO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 261 |
| 2023 | 1 | 166 |
| 2024 | 1 | 123 |
Compare with all 510(k) review times · Search every LAO clearance
Top LAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 3 | 2023-12-20 |
| Abbott Laboratories | 2 | 1993-07-14 |
| Syva Co. | 2 | 1983-12-22 |
| Roche Diagnostics Operations | 1 | 2024-02-20 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1989-01-30 |
1 more applicants have LAO clearances. See the full list in Caduvo.
Most recent LAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233454 | Roche Diagnostics Operations | ONLINE TDM Methotrexate | 2024-02-20 | 123 |
| K232017 | Ark Diagnostics, Inc. | ARK Methotrexate II Assay | 2023-12-20 | 166 |
| K163359 | Ark Diagnostics, Inc. | ARK Methotrexate Assay | 2017-08-18 | 261 |
| K111904 | Ark Diagnostics, Inc. | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | 2011-10-18 | 105 |
| K932615 | Abbott Laboratories | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | 1993-07-14 | 43 |
Recalls for LAO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-08.
Frequently asked questions
What is FDA product code LAO?
LAO is the FDA product code for enzyme immunoassay, methotrexate. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is LAO?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAO?
Across 10 cleared submissions the average was 95 days from receipt to decision (median 72).
Which companies have the most LAO clearances?
Ark Diagnostics, Inc. (3); Abbott Laboratories (2); Syva Co. (2); Roche Diagnostics Operations (1); E.I. Dupont DE Nemours & Co., Inc. (1).
Have LAO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-03-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LAO
- Run a recall and safety report across every LAO manufacturer
- Watch product code LAO 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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