510(k) · Cleared
ClearedAccusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · LAG High Pressure Liquid Chromatography, Methamphetamine
Cleared on Dec 18, 1998 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 18, 1998
- Review
- 73 days
- Class
- Class II
- Product code
- LAG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983501 Accusign Doa 10,Accusign Doa Panel,Accusign…Princeton BioMeditech Corp. · 1998
- Descendant · cites it directly · 0 of its ownK062575 Modification to: Accusign RC Doa 10…Princeton BioMeditech Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062575Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/AmpPrinceton BioMeditech Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983501 | Accusign Doa 10,Accusign Doa Panel,Accusign… | Princeton BioMeditech Corp. | 1998 | — |
| +1 | K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp | Princeton BioMeditech Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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 LAG? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp | 2007 | 0 |
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?
- Of its descendants, K062575 (Princeton BioMeditech Corp., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LAG devicesLAG High Pressure Liquid Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAG
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LAG
Too few LAG 510(k)s in any year since 2007 to give a median.
Recalls per year · LAG
No recall names LAG since 2007.
Adverse event reports per year · LAG
No MAUDE report names LAG 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 | 1 | — | 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 methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of drug of abuse samples. The detecting cut-oft concentrations are as follows:
MET D-Methamphetamine 1000 ng/mL
OPI Morphine 300 ng/mL
CcOoC 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
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/K983501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983501: Accusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983501
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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