FDA product code LOJ: Kit, Test,Alpha-Fetoprotein For Testicular Cancer
LOJ is the FDA product code for kit, test,alpha-fetoprotein for testicular cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 17 510(k) submissions under LOJ, 2 in the last five years, from 16 different applicants. The average 510(k) review took 135 days (median 84). 3 PMA applications cite this product code. FDA has posted 7 recalls for LOJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test,Alpha-Fetoprotein For Testicular Cancer |
| 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 LOJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 224 |
Top LOJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayer Corp. | 2 | 2002-03-27 |
| Roche Diagnostics | 1 | 2022-09-15 |
| Ortho Clinical Diagnostics | 1 | 2022-06-15 |
| Siemens Healthcare Diagnostics | 1 | 2009-04-27 |
| Olympus Life Science Research Europa GmbH (Europa) | 1 | 2009-03-16 |
11 more applicants have LOJ clearances. See the full list in Caduvo.
Most recent LOJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220176 | Roche Diagnostics | Elecsys AFP | 2022-09-15 | 237 |
| K213626 | Ortho Clinical Diagnostics | VITROS AFP | 2022-06-15 | 210 |
| K090236 | Siemens Healthcare Diagnostics | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | 2009-04-27 | 84 |
| K081709 | Olympus Life Science Research Europa GmbH (Europa) | OLYMPUS AFP - ALPHA-FETOPROTEIN | 2009-03-16 | 272 |
| K080017 | bioMerieux, Inc. | VIDAS AFP ASSAY | 2008-09-26 | 267 |
Recalls for LOJ devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LOJ?
LOJ is the FDA product code for kit, test,alpha-fetoprotein for testicular cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is LOJ?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code LOJ?
Across 17 cleared submissions the average was 135 days from receipt to decision (median 84).
Which companies have the most LOJ clearances?
Bayer Corp. (2); Roche Diagnostics (1); Ortho Clinical Diagnostics (1); Siemens Healthcare Diagnostics (1); Olympus Life Science Research Europa GmbH (Europa) (1).
Have LOJ devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LOJ
- Run a recall and safety report across every LOJ manufacturer
- Watch product code LOJ 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.