510(k) · Cleared
ClearedSalicylate 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. · DKJ Colorimetry, Salicylate
Cleared on Jul 11, 2002 as substantially equivalent to K844070 (Abbott Laboratories, 1984) after a 122-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jul 11, 2002
- Review
- 122 days
- Class
- Class II
- Product code
- DKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844070 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK844070 TDX SalicylateAbbott Laboratories · 1984 · Recalled
- This deviceK020794 Salicylate 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 | K844070 | TDX Salicylate | Abbott Laboratories | 1984 | 1 |
| 0 (this device) | K020794 | Salicylate 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 DKJ? 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 |
|---|---|---|---|
| * | K844070 | TDX SalicylateSummary page 2…n Performance of the ADVIA IMS SalicylateAssay on a Bayer ADVIA' IMSm is equivalent to the performance of the Salicylate Assay on the predicate device (Abbott TDX, K844070) and is w i h proposed manufacturing specifications.No safety and effectiveness issues have been raised.… | 1984 |
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 a recall.
- 1 other device also cites its predicate K844070.
How does its category compare?
All DKJ devicesDKJ Colorimetry, Salicylate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKJ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DKJ
Too few DKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DKJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKJ
1in 2020
MAUDE reports naming product code DKJ, 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 | 1 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 1 |
| 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 | 1 |
| 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 BayerADVLA UIS Salicylate methud is an in vilio diagno&c device intended to measure' salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the'diagnosis of salicylate toxicity and overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020794: Salicylate 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/K020794
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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