FDA product code LTK: Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
LTK is the FDA product code for test, epithelial ovarian tumor-associated antigen (ca125). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 26 510(k) submissions under LTK, 3 in the last five years, from 17 different applicants. The average 510(k) review took 209 days (median 178); 80 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 8 recalls for LTK devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LTK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 70 |
| 2022 | 1 | 216 |
| 2023 | 1 | 675 |
| 2024 | 1 | 80 |
Top LTK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 3 | 2024-05-10 |
| Bayer Corp. | 3 | 2002-07-24 |
| Fujirebio Diagnostics,Inc. | 2 | 2015-05-21 |
| bioMerieux, Inc. | 2 | 2009-06-22 |
| Tosoh Medics, Inc. | 2 | 2002-12-06 |
12 more applicants have LTK clearances. See the full list in Caduvo.
Most recent LTK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240479 | Beckman Coulter, Inc. | Access OV Monitor | 2024-05-10 | 80 |
| K213510 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | 2023-09-08 | 675 |
| K221355 | Ortho Clinical Diagnostics | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | 2022-12-12 | 216 |
| K200199 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CA 125II | 2020-04-06 | 70 |
| K143534 | Roche Professional Diagnostics | Elecsys CA-125 II assay | 2015-08-06 | 237 |
Recalls for LTK devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-21.
| Year | Recalls |
|---|---|
| 2018 | 3 |
Frequently asked questions
What is FDA product code LTK?
LTK is the FDA product code for test, epithelial ovarian tumor-associated antigen (ca125). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is LTK?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTK?
Across 26 cleared submissions the average was 209 days from receipt to decision (median 178).
Which companies have the most LTK clearances?
Beckman Coulter, Inc. (3); Bayer Corp. (3); Fujirebio Diagnostics,Inc. (2); bioMerieux, Inc. (2); Tosoh Medics, Inc. (2).
Have LTK devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2018-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LTK
- Run a recall and safety report across every LTK manufacturer
- Watch product code LTK 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.