510(k) · Cleared
ClearedBayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · DKB Calibrators, Drug Mixture
Cleared on Jan 29, 2002 as substantially equivalent to K904226 (Abbott Laboratories, 1990) after a 60-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jan 29, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904226 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
- This deviceK013959 Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur AnalyzersBayer Diagnostics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904226 | 'Tdxflx Analyzer | Abbott Laboratories | 1990 | — |
| 0 (this device) | K013959 | Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers | 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 DKB? 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 |
|---|---|---|---|
| * | K904226 | 'Tdxflx AnalyzerSummary page 1…AX: 914-524-2500 e-mail: [email protected] November 12, 2001 ADVIA Centaur and ACS:180 Valproic Acid Immunoassay Valproic acid Immunoassay TDx Valproic acid assay K904226 Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 The ACS and ADVIA Centaur Valproic acid assay is a competitive c… | 1990 |
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.
- 5 other devices also cite its predicate K904226.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of valproic acid in human serum and plasma for use on the automated analyzers marketed by Bayer Corporation. Valproic acid (2-propylpentanoic acid) is an anticonvulsant that is used alone or in combination with other anticonvulsant drugs to control seizures. Monitoring of valproic acid ensures that there is adequate drug in the blood stream without being at toxic levels. The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are used as an aid to monitor patients' valproic acid level.
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/K013959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013959: Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013959
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026