510(k) · Cleared
ClearedAmmonia Assay for the Advia Integrated Modular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · JIF Enzymatic Method, Ammonia
Cleared on Jul 13, 2002 as substantially equivalent to K760332 (Sigma Chemical Co., 1976) after a 94-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Jul 13, 2002
- Review
- 94 days
- Class
- Class I
- Product code
- JIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760332 (1976). No later device cites it as a predicate yet.
- Root · 1 generation backK760332 Sigma Ammonia ReagentSigma Chemical Co. · 1976
- This deviceK021151 Ammonia Assay for the Advia Integrated Modular SystemBayer Diagnostics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760332 | Sigma Ammonia Reagent | Sigma Chemical Co. | 1976 | — |
| 0 (this device) | K021151 | Ammonia Assay for the Advia Integrated Modular System | Bayer Diagnostics Corp. | 2002 | — |
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 JIF? 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 |
|---|---|---|---|
| * | K760332 | Sigma Ammonia ReagentSummary page 2…nclusion Performance for the ADVIA IMS Ammonia Assay on the Bayer ADVIA@IMSTM is equivalent to the performance of the Ammonia Assay on the predicate device (Sigma, K760332) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.… | 1976 |
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 JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIF
Too few JIF 510(k)s in any year since 2007 to give a median.
Recalls per year · JIF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIF
5in 2025
MAUDE reports naming product code JIF, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bayer ADP32 IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye’s syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021151: Ammonia Assay for the Advia Integrated Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021151
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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