510(k) · Cleared
ClearedStatus Cup Accusign Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · DKE Reagents, Test, Tetrahydrocannabinol
Cleared on Jun 18, 1999 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 18, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- DKE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 DKE? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All DKE devicesDKE Reagents, Test, Tetrahydrocannabinol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKE
FDA has decided no DKE device since 2007.
Median 510(k) review, days · DKE
Too few DKE 510(k)s in any year since 2007 to give a median.
Recalls per year · DKE
No recall names DKE since 2007.
Adverse event reports per year · DKE
No MAUDE report names DKE since 2007.
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 | 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 | 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 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the qualitative detection of amphetamine, THC metabolites, cocaine metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
AMP Amphetamine 1000 ng/mL
THC 11-nor-A’-9-carboxylic acid 50 ng/mL
COC Benzoylecgonine 300 ng/mL
MET D-Methamphetamine 1000 ng/mL
OPI Morphine 300 ng/mL
PCP Phencyclidine 25 ng/mL
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/K991751 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991751: Status Cup Accusign Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991751
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026