FDA product code MLE: Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
MLE is the FDA product code for enzyme immunoassay, antiparietal cell antibody, antigen, control. It is a Class II device, regulated under 21 CFR 866.5110 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under MLE, from 3 different applicants. The average 510(k) review took 48 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5110 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MLE clearance
Top MLE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2001-04-03 |
| Cogent Diagnotics , Ltd. | 1 | 1999-08-24 |
| Elias U.S.A., Inc. | 1 | 1995-04-17 |
Most recent MLE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010558 | Inova Diagnostics, Inc. | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | 2001-04-03 | 36 |
| K991942 | Cogent Diagnotics , Ltd. | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | 1999-08-24 | 76 |
| K951206 | Elias U.S.A., Inc. | VARELISA PARIETAL CELL ANTIBODIES | 1995-04-17 | 31 |
Recalls for MLE devices
openFDA lists no recalls for product code MLE.
Frequently asked questions
What is FDA product code MLE?
MLE is the FDA product code for enzyme immunoassay, antiparietal cell antibody, antigen, control. It is a Class II device, regulated under 21 CFR 866.5110 and reviewed by the Immunology panel.
What device class is MLE?
Class II, regulation 21 CFR 866.5110. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLE?
Across 3 cleared submissions the average was 48 days from receipt to decision (median 36).
Which companies have the most MLE clearances?
Inova Diagnostics, Inc. (1); Cogent Diagnotics , Ltd. (1); Elias U.S.A., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLE
- Run a recall and safety report across every MLE manufacturer
- Watch product code MLE 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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