510(k) · Cleared
ClearedLifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · LDJ Enzyme Immunoassay, Cannabinoids
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
- LDJ
- 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 deviceK014066 Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign…Princeton 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) | K014066 | Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik… | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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…lysis Systems, Toxicology (91DKE for Enzyme Immunoassay) 4. Identification of legally marketed device to which claims equivalence: k990786 status DS'%OA I o (MET/OPI/COC/THC/PCP/BZO/BARMTD/TCNAMP) 5. Device Description: Status Stikm THC 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 LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the qualitative detection of THC metabolite, 11-nor-A9-THC-9-carboxylic acid, at the cut-off of 50 ng/rnL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use
Immunoassay for the qualitative detection of THC metabolite, 11-nor-A9-THC-9-carboxylic acid, at the cut-off of 50 nglmL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014066: Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014066
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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