FDA product code LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
LIP is the FDA product code for enzyme linked immunoabsorption assay, treponema pallidum. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. FDA has cleared 35 510(k) submissions under LIP, 2 in the last five years, from 24 different applicants. The average 510(k) review took 182 days (median 137); 100 days on average over the last three years. FDA has posted 18 recalls for LIP devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LIP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2021 | 1 | 82 |
| 2024 | 2 | 100 |
Compare with all 510(k) review times · Search every LIP clearance
Top LIP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mercia Diagnostics , Ltd. | 4 | 1990-12-26 |
| Roche Diagnostics | 2 | 2021-07-20 |
| Bio-Rad Laboratories | 2 | 2017-05-11 |
| Phoenix Biotech Corp. | 2 | 2006-08-07 |
| DiaSorin, Inc. | 2 | 2006-07-31 |
19 more applicants have LIP clearances. See the full list in Caduvo.
Most recent LIP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241427 | Beckman Coulter, Inc. | Access Syphilis | 2024-09-06 | 109 |
| K241534 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Syphilis Reagent Pack | 2024-08-28 | 90 |
| K211302 | Roche Diagnostics | Elecsys Syphilis | 2021-07-20 | 82 |
| K170413 | Bio-Rad Laboratories | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | 2017-05-11 | 90 |
| K160910 | Roche Diagnostics | Elecsys Syphilis | 2016-07-28 | 118 |
Recalls for LIP devices
18 product recalls in 15 recall events; 5 initiated in the last five years and 9 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code LIP?
LIP is the FDA product code for enzyme linked immunoabsorption assay, treponema pallidum. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is LIP?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIP?
Across 35 cleared submissions the average was 182 days from receipt to decision (median 137).
Which companies have the most LIP clearances?
Mercia Diagnostics , Ltd. (4); Roche Diagnostics (2); Bio-Rad Laboratories (2); Phoenix Biotech Corp. (2); DiaSorin, Inc. (2).
Have LIP devices been recalled?
Yes: 18 product recalls across 15 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LIP
- Run a recall and safety report across every LIP manufacturer
- Watch product code LIP 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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