510(k) · Cleared
ClearedLifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Jun 10, 2002 as substantially equivalent to K990786 (Princeton BioMeditech Corp., 1999) after a 182-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 10, 2002
- Review
- 182 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990786 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990786 Accusign Doa 10, Accusign Doa 10 Panel, Acusign…Princeton BioMeditech Corp. · 1999
- This deviceK014069 Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik CocPrinceton BioMeditech Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990786 | Accusign Doa 10, Accusign Doa 10 Panel, Acusign… | Princeton BioMeditech Corp. | 1999 | — |
| 0 (this device) | K014069 | Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc | Princeton BioMeditech Corp. | 2002 | — |
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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K990786 | Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp…Summary page 1…ysis Systems, Toxicology (91DIO for Enzyme Immunoassay) 4. Identification of legally marketed device to which claims equivalence: -k990786; StatusDS'"DOA1 O(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCAIAMP) 5. Device Description: LifeSign@Home Drug Test (COC) is simple one… | 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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K990786.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ngimL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse at home. For In vitro Diagnostic Use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014069: Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014069
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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