FDA product code LPT: System, Test, Urinary Methylmalonic Acid
LPT is the FDA product code for system, test, urinary methylmalonic acid. It is a Class II device, regulated under 21 CFR 862.1509 and reviewed by the Clinical Chemistry panel. Devices under LPT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for LPT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Urinary Methylmalonic Acid |
| Device class | Class II |
| Regulation | 21 CFR 862.1509 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for LPT devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LPT?
LPT is the FDA product code for system, test, urinary methylmalonic acid. It is a Class II device, regulated under 21 CFR 862.1509 and reviewed by the Clinical Chemistry panel.
What device class is LPT?
Class II, regulation 21 CFR 862.1509. Typical premarket route: 510(k) exempt.
Have LPT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LPT
- Run a recall and safety report across every LPT manufacturer
- Watch product code LPT 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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