510(k) Report

510(k) · Cleared

Cleared

Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp, Biosign DOA10, Biosign Met/Opi/

K990786510(k) SpecialCleared Mar 26, 199916-day reviewClass II21 CFR 862.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Princeton BioMeditech Corp. · LAG High Pressure Liquid Chromatography, Methamphetamine

Cleared on Mar 26, 1999 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Mar 26, 1999
Review
16 days
Class
Class II
Product code
LAG
Recalls
None
Predicates
0

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 5 descendants cleared2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990786 Accusign Doa 10, Accusign Doa 10 Panel, Acusign…Princeton BioMeditech Corp. · 1999
  2. Descendant · cites it directly · 1 of its ownK014193 Lifesign Doa 4 (THC/Opi/Coc/Met)Princeton BioMeditech Corp. · 2002
  3. Descendant · cites it directly · 1 of its ownK014192 Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met…Princeton BioMeditech Corp. · 2002
  4. Descendant · 2 generations on · 0 of its ownK023837 Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma…Princeton BioMeditech Corp. · 2003
  5. Descendant · cites it directly · 0 of its ownK014067 Lifesign Cocaine, Marijuana (THC), Lifesign DOA2 (THC/Coc), Status…Princeton BioMeditech Corp. · 2002
  6. Descendant · cites it directly · 0 of its ownK014066 Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign…Princeton BioMeditech Corp. · 2002

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 52003: 1
2002high 5 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K014193Lifesign Doa 4 (THC/Opi/Coc/Met)Princeton BioMeditech Corp. · 2002 · cites it directly1descendant
  • K014192Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS…Princeton BioMeditech Corp. · 2002 · cites it directly1descendant
  • K023837Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma…Princeton BioMeditech Corp. · 2003 · 2 generations on0descendants
  • K014067Lifesign Cocaine, Marijuana (THC), Lifesign DOA2 (THC/Coc), Status Stik THC/Coc…Princeton BioMeditech Corp. · 2002 · cites it directly0descendants
  • K014066Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THCPrinceton BioMeditech Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990786Accusign Doa 10, Accusign Doa 10 Panel, Acusign…Princeton BioMeditech Corp.1999—
+1K014193Lifesign Doa 4 (THC/Opi/Coc/Met)Princeton BioMeditech Corp.2002—
+1K014192Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met…Princeton BioMeditech Corp.2002—
+2K023837Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik…Princeton BioMeditech Corp.2003—
+1K014067Lifesign Cocaine, Marijuana (THC), Lifesign DOA2 (THC/Coc), Status Stik…Princeton BioMeditech Corp.2002—
+1K014066Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik…Princeton BioMeditech Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200250
200310
FIG. 1 — Lineage of K990786, 1999–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014193Lifesign Doa 4 (THC/Opi/Coc/Met)Princeton BioMeditech Corp.20021
K014192Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS…Princeton BioMeditech Corp.20021
K014067Lifesign Cocaine, Marijuana (THC), Lifesign DOA2 (THC/Coc), Status Stik THC/Coc…Princeton BioMeditech Corp.20020
K014066Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THCPrinceton BioMeditech Corp.20020
K014069Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik CocPrinceton BioMeditech Corp.20020

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, K014193 (Princeton BioMeditech Corp., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LAG devices

LAG High Pressure Liquid Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAG

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—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 abusc samples. The detection cut-off concentrations are as follows:

MET — d-Methamphetamine — 1000 ng/mL

OPI — Morphine — 300 ng/mL

COoC — 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

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Princeton BioMeditech Corp.

72 FDA decisions under this applicant name. See the company

  • K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. · 2025
  • K182157BioSign Flu A+BPrinceton BioMeditech Corp. · 2018
  • K130650Status DS OxyPrinceton BioMeditech Corp. · 2014
  • K133474Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013
  • K132465Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013

Recent decisions in LAG

The LAG category page

  • K073078Rapid Tox CupAmerican Bio Medica Corp. · 2008
  • K062575Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/AmpPrinceton BioMeditech Corp. · 2007
  • K983501Accusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp,Biosign Doa 10, Biosign…Princeton BioMeditech Corp. · 1998

https://510kreport.com/device/K990786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990786: Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp, Biosign DOA10, Biosign Met/Opi/.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990786

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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