510(k) · Cleared
ClearedAdvia Ims Cpsa Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 6, 2006 as substantially equivalent to K033379 (Bayer Diagnostics Corp., 2003) after a 73-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jul 6, 2006
- Review
- 73 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023840 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK023840 Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
- 2 generations backK030801 Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC · 2003
- 1 generation backK033379 Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003
- This deviceK061137 Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023840 | Acid Phosphatase Assay for the Advia 1650 | Bayer Diagnostics Corp. | 2003 | — |
| −2 | K030801 | Bayer Advia 1650 Special Chemistry Control | Bayer Healthcare, LLC | 2003 | — |
| −1 | K033379 | Bayer Special Chemistry Controls | Bayer Diagnostics Corp. | 2003 | — |
| 0 (this device) | K061137 | Advia Ims Cpsa Control | 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 JJY? 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 |
|---|---|---|---|
| * | K033379 | Bayer Special Chemistry ControlsSummary page 2…Chemistry (75) Product Code: JJY Predicate Device: Bayer Special Chemistry Controls Premarket Notification Number: K033379 Device Description: The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The… | 2003 |
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 3 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno I® systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061137: Advia Ims Cpsa Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061137
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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