510(k) · Cleared
ClearedEmit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109UL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · DKJ Colorimetry, Salicylate
Cleared on Aug 13, 2001 as substantially equivalent to K951290 (Abbott Laboratories, 1995) after a 59-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 13, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- DKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951290 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951290 Axsym SalicylateAbbott Laboratories · 1995
- This deviceK011878 Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic…Syva Co. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951290 | Axsym Salicylate | Abbott Laboratories | 1995 | — |
| 0 (this device) | K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid… | Syva Co. | 2001 | — |
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 |
|---|---|---|---|
| * | K951290 | Axsym SalicylateSummary page 1…d in human serum or plasma. The Emit tox™ Salicylic Acid Assay and Calibrators have been found to be equivalent to the predicate device: Abbott AxXSYM® Salicylate Assay (K951290) with regard to intended use, assay sample, and overall performance characteristics. Specificy: Compounds, whose chemical struct… | 1995 |
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 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 Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in manitoring levels of salicylic acid 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/K011878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011878: Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011878
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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