510(k) · Cleared
ClearedEmit Caffeine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · KLS Enzyme Immunoassay, Theophylline
Cleared on Oct 28, 2004 as substantially equivalent to K853872 (Syva Co., 1986) after a 55-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Oct 28, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- KLS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853872 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK853872 Emit Caffeine AssaySyva Co. · 1986
- This deviceK042407 Emit Caffeine AssayDade Behring, 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) | K042407 | Emit Caffeine Assay | Dade Behring, Inc. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K853872 | Emit Caffeine AssaySummary page 1…® Caffeine Assay / Enzyme immunoassay, Theophylline Product code: 91 KLS 3. Identification of the Legally Marketed Device Emit® Caffeine Assay - K853872 4. Device Description The Emit® Caffeine Assay is a homogeneous enzyme immunoassay technique used for the an… | 1986 |
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.
- 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?
The Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042407: Emit Caffeine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042407
Report an extraction error
Are you the manufacturer?
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