510(k) · Cleared
ClearedBayer Special Chemistry Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 19, 2003 as substantially equivalent to K030801 (Bayer Healthcare, LLC, 2003) after a 58-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Dec 19, 2003
- Review
- 58 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023840 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK023840 Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
- 1 generation backK030801 Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC · 2003
- This deviceK033379 Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK061137 Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006
Most influential descendants
Showing 1 of 1 · See all- K061137Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023840 | Acid Phosphatase Assay for the Advia 1650 | Bayer Diagnostics Corp. | 2003 | — |
| −1 | K030801 | Bayer Advia 1650 Special Chemistry Control | Bayer Healthcare, LLC | 2003 | — |
| 0 (this device) | K033379 | Bayer Special Chemistry Controls | Bayer Diagnostics Corp. | 2003 | — |
| +1 | K061137 | Advia Ims Cpsa Control | Bayer Healthcare, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030801 | Bayer Advia 1650 Special Chemistry ControlSummary page 1…Chemistry (75) Product Code: JJY Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K030801 Device Description: The Bayer Special Chemistry Controls are two separate levels of quality contro… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061137 | Advia Ims Cpsa Control | 2006 | 0 |
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 0 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061137 (Bayer Healthcare, LLC, 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030801.
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 Chemistry systems for certain chemistry methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033379 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033379: Bayer Special Chemistry Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033379
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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