510(k) · Cleared
ClearedAuto-Lyte Cotinine Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OraSure Technologies, Inc. · MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Cleared on Oct 21, 1997 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 21, 1997
- Review
- 111 days
- Class
- Class I
- Product code
- MKU
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK972481 Auto-Lyte Cotinine EiaOraSure Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK062565 Status DS Nicotine, Accusign Nicotine, Biosign NicotinePrinceton BioMeditech Corp. · 2007
- Descendant · cites it directly · 0 of its ownK030649 Dri Cotinine Eia AssayMicrogenics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK021944 Cozart Eia Cotinine Urine KitCozart Bioscience, Ltd. · 2003
Most influential descendants
Showing 3 of 3 · See all- K062565Status DS Nicotine, Accusign Nicotine, Biosign NicotinePrinceton BioMeditech Corp. · 2007 · cites it directly0descendants
- K030649Dri Cotinine Eia AssayMicrogenics Corp. · 2003 · cites it directly0descendants
- K021944Cozart Eia Cotinine Urine KitCozart Bioscience, Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972481 | Auto-Lyte Cotinine Eia | OraSure Technologies, Inc. | 1997 | — |
| +1 | K062565 | Status DS Nicotine, Accusign Nicotine, Biosign Nicotine | Princeton BioMeditech Corp. | 2007 | — |
| +1 | K030649 | Dri Cotinine Eia Assay | Microgenics Corp. | 2003 | — |
| +1 | K021944 | Cozart Eia Cotinine Urine Kit | Cozart Bioscience, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
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 MKU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MKU device
- #1 K192517 Psychemedics Microplate EIA for Cotinine in Hairscore -0.8 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062565 (Princeton BioMeditech Corp., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MKU devicesMKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKU
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MKU
Too few MKU 510(k)s in any year since 2007 to give a median.
Recalls per year · MKU
No recall names MKU since 2007.
Adverse event reports per year · MKU
No MAUDE report names MKU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 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 STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972481 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972481: Auto-Lyte Cotinine Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972481
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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