510(k) · Cleared
ClearedBayer Advia 1650 Special Chemistry 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 Apr 9, 2003 as substantially equivalent to K023840 (Bayer Diagnostics Corp., 2003) after a 27-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Apr 9, 2003
- Review
- 27 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023840 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023840 Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
- This deviceK030801 Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 1 of its ownK033379 Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK061137 Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006
- Descendant · cites it directly · 0 of its ownK031644 Bayer Advia Chemistry Special Chemistry ControlBayer Healthcare, LLC · 2003
Most influential descendants
Showing 3 of 3 · See all- K033379Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003 · cites it directly1descendant
- K061137Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006 · 2 generations on0descendants
- K031644Bayer Advia Chemistry Special Chemistry ControlBayer Healthcare, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023840 | Acid Phosphatase Assay for the Advia 1650 | Bayer Diagnostics Corp. | 2003 | — |
| 0 (this device) | K030801 | Bayer Advia 1650 Special Chemistry Control | Bayer Healthcare, LLC | 2003 | — |
| +1 | K033379 | Bayer Special Chemistry Controls | Bayer Diagnostics Corp. | 2003 | — |
| +2 | K061137 | Advia Ims Cpsa Control | Bayer Healthcare, LLC | 2006 | — |
| +1 | K031644 | Bayer Advia Chemistry Special Chemistry Control | Bayer Healthcare, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
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 |
|---|---|---|---|
| * | K023840 | Acid Phosphatase Assay for the Advia 1650 | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 in the control of ADVIA 1650 Chemistry system for certain chemistry methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030801: Bayer Advia 1650 Special Chemistry Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030801
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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