510(k) · Cleared
ClearedTroponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · MMI Immunoassay Method, Troponin Subunit
Cleared on Dec 6, 1999 as substantially equivalent to K973616 (Bayer Corp., 1997) after a 62-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 6, 1999
- Review
- 62 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973616 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973616 Troponin I Assay for the Bayer Immuno 1 SystemBayer Corp. · 1997
- This deviceK993353 Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic…Bayer Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973616 | Troponin I Assay for the Bayer Immuno 1 System | Bayer Corp. | 1997 | — |
| 0 (this device) | K993353 | Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System) | Bayer Corp. | 1999 | — |
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 MMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMI device
- #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K973616 | Troponin I Assay for the Bayer Immuno 1 SystemSummary page 1…uid calibrators are provided with values of 0,5,10,20,60, and 200 ng/mL Troponin I. The Bayer Immuno 1Troponin I Assay was previously cleared under Document Control No. K973616. The proposed Bayer Inmuno 1 Troponin I Assay is substantially equivalent in technical performance and intended use to the FDA cl… | 1997 |
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 MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, 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 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This in vitro diagnostic method intended to quantitatively measure the concentration of cardiac Troponin 1 (Tnl) in human serum and plasma (lithium heparin) using the Bayer Immuno 1 system. When used in conjunction with other clinical data, such as presenting symptoms and diagnostic procedures, measurements of cardiac Tnl aids in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation…
Read the full statement (101 words)
This in vitro diagnostic method intended to quantitatively measure the concentration of cardiac Troponin 1 (Tnl) in human serum and plasma (lithium heparin) using the Bayer Immuno 1 system. When used in conjunction with other clinical data, such as presenting symptoms and diagnostic procedures, measurements of cardiac Tnl aids in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revalcularization procedures.
This diagnostic method is not intended for use on any other 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/K993353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993353: Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993353
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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