510(k) · Cleared
ClearedBayer Psa Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on Apr 13, 2000 as substantially equivalent to P850021 (Abbott Vascular, Inc., 1986) after a 120-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 13, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P850021 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backP850021 Amer, ED. Labs. PtcaAbbott Vascular, Inc. · 1986
- This deviceK994221 Bayer Psa AssayBayer Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P850021 | Amer, ED. Labs. Ptca | Abbott Vascular, Inc. | 1986 | — |
| 0 (this device) | K994221 | Bayer Psa Assay | Bayer Corp. | 2000 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LTJ device
- #1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P850021 | Amer, ED. Labs. PtcaSummary page 1…numbers unknown Predicate Device Information Name: _ Immuno | PEA Immunoassay Manufacturer: Bayer Diagnostics The Immuno 1 PSA Immunoassay was approved by FDA as PMA #P850021 and downclassified to class 1l by 21 CFR 866.6010, Tumor Associated Antigenimmunological Test System on Dec 17, 1997. Device Des… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LTJ devicesLTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTJ
Too few LTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTJ
14in 2025
MAUDE reports naming product code LTJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 3 | 57 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 0 | — | 2 | 34 |
| 2011 | 0 | — | 0 | 109 |
| 2012 | 0 | — | 0 | 101 |
| 2013 | 1 | — | 1 | 69 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 10 | — | 0 | 13 |
| 2018 | 7 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 2 | — | 0 | 17 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 3 | — | 1 | 14 |
| 2026 | 3 | — | 0 | — |
What is it indicated for?
The Bayer Diagnostics PSA Immunoassay is for the quantitative serial determination of prostate specific antigen in human serum and to aid in the management (monitoring) of patients with prostate cancer.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994221: Bayer Psa Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994221
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026