510(k) · Cleared
ClearedAdvia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Jan 24, 2003 as substantially equivalent to K960246 (Ciba Corning Diagnostics Corp., 1996) after a 14-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 24, 2003
- Review
- 14 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960246 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960246 Liquid Cardiac Marker 1,2,3 AssayedCiba Corning Diagnostics Corp. · 1996
- This deviceK030102 Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960246 | Liquid Cardiac Marker 1,2,3 Assayed | Ciba Corning Diagnostics Corp. | 1996 | — |
| 0 (this device) | K030102 | Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3 | Bayer Healthcare, LLC | 2003 | — |
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 JJT? 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 |
|---|---|---|---|
| * | K960246 | Liquid Cardiac Marker 1,2,3 AssayedSummary page 1…Chemistry (75) Product Code: JJT 3. Predicate Device: Liquid Cardiac Markers 1,2,3 Premarket Notification Number: K960246 4. Device Description: The Bayer Liquid Cardiac Markers 1, 2, 3 are three separate levels of quality contro… | 1996 |
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 JJT devicesJJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJT
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JJT
Too few JJT 510(k)s in any year since 2007 to give a median.
Recalls per year · JJT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJT
1in 2011
MAUDE reports naming product code JJT, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur@ and ACS:180@ Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030102: Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030102
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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