510(k) · Cleared
ClearedBayer Advia Integrated Modular System (Ims)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Cleared on Nov 9, 1999 after a 138-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 9, 1999
- Review
- 138 days
- Class
- Class II
- Product code
- CIT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK992136 Bayer Advia Integrated Modular System (Ims)Bayer Corp. · 1999
- Descendant · cites it directly · 0 of its ownK071580 Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007
Most influential descendants
Showing 1 of 1 · See all- K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992136 | Bayer Advia Integrated Modular System (Ims) | Bayer Corp. | 1999 | — |
| +1 | K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol | Thermofisher Scientific OY | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 CIT? 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? (4)
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 |
|---|---|---|---|
| * | — | Bayer CHEM® 1 AST method Named without a submission number | |
| * | — | Bayer CHEM 1® CK method Named without a submission number | |
| * | — | Bayer Chem 1® Creatinine method Named without a submission number | |
| * | — | Technicon RA-1000 method Named without a submission number |
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 |
|---|---|---|---|
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol | 2007 | 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?
- Of its descendants, K071580 (Thermofisher Scientific OY, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CIT devicesCIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CIT
Too few CIT 510(k)s in any year since 2007 to give a median.
Recalls per year · CIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIT
10in 2025
MAUDE reports naming product code CIT, 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 | 2 | — | 0 | 23 |
| 2008 | 2 | — | 3 | 17 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and…
Read the full statement (184 words)
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne’s dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
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/K992136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992136: Bayer Advia Integrated Modular System (Ims).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992136
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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