510(k) · Cleared
ClearedVitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · KLS Enzyme Immunoassay, Theophylline
Cleared on Nov 30, 2004 as substantially equivalent to K853872 (Syva Co., 1986) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Nov 30, 2004
- Review
- 75 days
- Class
- Class II
- Product code
- KLS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K853872 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK853872 Emit Caffeine AssaySyva Co. · 1986
- This deviceK042520 Vitros Chemistry Products Caffn Reagent Kit and TDM Performance…Ortho-Clinical Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853872 | Emit Caffeine Assay | Syva Co. | 1986 | — |
| 0 (this device) | K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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 KLS? 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? (2)
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 |
|---|---|---|---|
| * | K853872 | Emit Caffeine AssaySummary page 3…vice: Reagent Kit The VITROS Chemistry Products CAFFN Reagent Kit is substantially equivalent to the SYVA Emit Caffeine Assay, which was cleared by FDA (K853872) for IVD use. For this device, the intended use includes the application of the test in monitoring patients treate… | 1986 |
| * | K984288 | Vitros Chemistry Products PHBR SlidesSummary page 4…age and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution (K984288). The only difference is the addition of caffeine to the controls. The labeling will be updated to add assigned values for… | 1999 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K853872.
How does its category compare?
All KLS devicesKLS Enzyme Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLS
FDA has decided no KLS device since 2007.
Median 510(k) review, days · KLS
Too few KLS 510(k)s in any year since 2007 to give a median.
Recalls per year · KLS
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLS
1in 2025
MAUDE reports naming product code KLS, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 2 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. For in vitro diagnostic use only. VITROS Chemistry Products CAEFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
2. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PIIYT and CAFFN on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042520: Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042520
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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