510(k) · Cleared
Recalled · 2006Salicylate-SL Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · DKJ Colorimetry, Salicylate
Cleared on Dec 27, 2004 after a 122-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Dec 27, 2004
- Review
- 122 days
- Class
- Class II
- Product code
- DKJ
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2006 | Not classified | Z-0361-2007 | Other | Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to… |
No ancestor or descendant has a Class I recall.
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 Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic 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 510(k) statement.
https://510kreport.com/device/K042329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042329: Salicylate-SL Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042329
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026