510(k) · Cleared
ClearedBayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JIT Calibrator, Secondary
Cleared on Jul 6, 2006 as substantially equivalent to K051619 (Bayer Healthcare, LLC, 2005) after a 73-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jul 6, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K990460 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- 3 generations backK030169 Setpoint Chemistry CalibratorBayer Healthcare, LLC · 2003
- 2 generations backK031682 Lipoprotein CalibratorBayer Healthcare, LLC · 2003
- 1 generation backK051619 Lipoprotein for Multiple AnalytesBayer Healthcare, LLC · 2005
- This deviceK061139 Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| −3 | K030169 | Setpoint Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| −2 | K031682 | Lipoprotein Calibrator | Bayer Healthcare, LLC | 2003 | — |
| −1 | K051619 | Lipoprotein for Multiple Analytes | Bayer Healthcare, LLC | 2005 | — |
| 0 (this device) | K061139 | Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators | Bayer Healthcare, LLC | 2006 | — |
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 JIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K051619 | Lipoprotein for Multiple AnalytesSummary page 2…Chemistry (75) Product Code: JIT Predicate Device: Lipoprotein Calibrator Premarket Notification Number: K051619 Device Description: The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator… | 2005 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS System.
For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.
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/K061139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061139: Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061139
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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