# K062575: Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Nov 26, 2007 after 452 days
- Product code: LAG (High Pressure Liquid Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983501 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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/, Princeton BioMeditech Corp. (1998) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K062575
Methodology: https://510kreport.com/methodology