510(k) · Cleared
ClearedStatus DS Nicotine, Accusign Nicotine, Biosign Nicotine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Cleared on Feb 20, 2007 as substantially equivalent to K972481 (OraSure Technologies, Inc., 1997) after a 173-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 20, 2007
- Review
- 173 days
- Class
- Class I
- Product code
- MKU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972481 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972481 Auto-Lyte Cotinine EiaOraSure Technologies, Inc. · 1997
- This deviceK062565 Status DS Nicotine, Accusign Nicotine, Biosign NicotinePrinceton BioMeditech Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972481 | Auto-Lyte Cotinine Eia | OraSure Technologies, Inc. | 1997 | — |
| 0 (this device) | K062565 | Status DS Nicotine, Accusign Nicotine, Biosign Nicotine | Princeton BioMeditech Corp. | 2007 | — |
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 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? (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 |
|---|---|---|---|
| * | K972481 | Auto-Lyte Cotinine EiaSummary page 1…Product Code: MKU) 4. Identification of legally marketed device to which claims equivalence: k97248 1; Auto-Lyte Cotinine ETA 5. Device Description: Status DS Tm Nicotine is a simple one step inmmuochromatographic… | 1997 |
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.
- 2 other devices also cite its predicate K972481.
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. 2007, this device’s year, is highlighted.
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?
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DSTM Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a…
Read the full statement (172 words)
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DSTM Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use
The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. AccuSign® Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use
The AccuSign® Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062565: Status DS Nicotine, Accusign Nicotine, Biosign Nicotine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062565
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