510(k) · Cleared
ClearedAccusign DOA3,Doa, Coc/THC/OPI2000 DOA3; Biosign DOA3, Coc/THC/OPI2000; Status DS Coc/THC/OPI2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Aug 10, 1999 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 10, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- DJG
- 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection cut-off concentrations are as follows: MET d-Methamphetamine 1000 ng/mL OPI Morphine 2000 ng/mL COC Benzoylecgonine 300 ng/mL THC 11-nor-A’-9-carboxylic acid 50 ng/mL…
Read the full statement (248 words)
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection cut-off concentrations are as follows:
MET d-Methamphetamine 1000 ng/mL
OPI Morphine 2000 ng/mL
COC Benzoylecgonine 300 ng/mL
THC 11-nor-A’-9-carboxylic acid 50 ng/mL
PCP Phencyclidine 25 ng/mL
Benzodiazepine Oxazepam 300 ng/mL
Barbiturate Secobarbital 300 ng/mL
Methadone Methadone 300 ng/mL
TCA Nortriptyline 1000 ng/mL
Amphetamine d-Amphetamine 1000 ng/mL
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, cocaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
THC 11-nor-A%-9-carboxylic acid 50 ng/mL
OPI Morphine 2000 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 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/K992422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992422: Accusign DOA3,Doa, Coc/THC/OPI2000 DOA3; Biosign DOA3, Coc/THC/OPI2000; Status DS Coc/THC/OPI2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992422
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)
- Page last updated Nov 3, 2026