FDA product code LTJ: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
LTJ is the FDA product code for prostate-specific antigen (psa) for management of prostate cancers. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 34 510(k) submissions under LTJ, 1 in the last five years, from 20 different applicants. The average 510(k) review took 122 days (median 88); 222 days on average over the last three years. 9 PMA applications cite this product code. FDA has posted 12 recalls for LTJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers |
| 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 LTJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 266 |
| 2026 | 1 | 222 |
Compare with all 510(k) review times · Search every LTJ clearance
Top LTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 5 | 1998-10-27 |
| Bayer Corp. | 4 | 2002-12-17 |
| Diagnostic Products Corp. | 3 | 1998-04-21 |
| Dade Behring, Inc. | 2 | 2003-05-15 |
| Oncogene Science, Inc. | 2 | 2000-08-30 |
15 more applicants have LTJ clearances. See the full list in Caduvo.
Most recent LTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251630 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Total PSA II (tPSAII) | 2026-01-05 | 222 |
| K162378 | Nanoentek USA, Inc. | FREND PSA PLUS (reagent cartridge) | 2017-05-17 | 266 |
| K124056 | Nanoentek, Inc. | FREND PSA PLUS (REAGENT CARTRIDGE) | 2013-05-29 | 149 |
| K031343 | Dade Behring, Inc. | TPSA FLEX REAGENT CARTRIDGE | 2003-05-15 | 16 |
| K022177 | Bayer Diagnostics Corp. | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 2002-12-17 | 167 |
Recalls for LTJ devices
12 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LTJ?
LTJ is the FDA product code for prostate-specific antigen (psa) for management of prostate cancers. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is LTJ?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTJ?
Across 34 cleared submissions the average was 122 days from receipt to decision (median 88).
Which companies have the most LTJ clearances?
Boehringer Mannheim Corp. (5); Bayer Corp. (4); Diagnostic Products Corp. (3); Dade Behring, Inc. (2); Oncogene Science, Inc. (2).
Have LTJ devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LTJ
- Run a recall and safety report across every LTJ manufacturer
- Watch product code LTJ 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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