510(k) · Cleared
ClearedModification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp
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 Nov 26, 2007 as substantially equivalent to K983501 (Princeton BioMeditech Corp., 1998) after a 452-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 26, 2007
- Review
- 452 days
- Class
- Class II
- Product code
- LAG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983501 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983501 Accusign Doa 10,Accusign Doa Panel,Accusign…Princeton BioMeditech Corp. · 1998
- This deviceK062575 Modification to: Accusign RC Doa 10…Princeton BioMeditech Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983501 | Accusign Doa 10,Accusign Doa Panel,Accusign… | Princeton BioMeditech Corp. | 1998 | — |
| 0 (this device) | K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp | Princeton BioMeditech Corp. | 2007 | — |
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 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? (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 |
|---|---|---|---|
| * | K983501 | Accusign Doa 10,Accusign Doa Panel,Accusign…Summary page 1…urine Classification Name: Drugs of abuse test systems, Clinical toxicology test system 4. Identification of legally marketed device to which claims equivalence: k983 501: AccuSign® DOAlI0 (MET/OPI/COC/THC/PCP/BZO/BAR/JMTD/TCA/AMP) by Princeton BioMeditech Corporation 5. Device Descr… | 1998 |
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.
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. 2007, this device’s year, is highlighted.
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 metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows: MET D-Methamphetamine 1000 ng/mL OPI Morphine 300 ng/mL COC Benzoylecgonine 300 ng/mL THC 11-nor-Ag-9-carboxylic acid 50 ng/mL PCP…
Read the full statement (143 words)
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:
MET D-Methamphetamine 1000 ng/mL
OPI Morphine 300 ng/mL
COC Benzoylecgonine 300 ng/mL
THC 11-nor-Ag-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
AMP D-Amphetamine 1000 ng/mL
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS)/High performance liquid chromatography (HPLC, for TCA) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062575: Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062575
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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