510(k) · Cleared

Cleared

Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met

K014192510(k) TraditionalCleared May 23, 2002153-day reviewClass U

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

Princeton BioMeditech Corp. · MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

Cleared on May 23, 2002 as substantially equivalent to K990786 (Princeton BioMeditech Corp., 1999) after a 153-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: May 23, 2002
Review: 153 days
Class: Class U
Product code: MVO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990786 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK990786 Accusign Doa 10, Accusign Doa 10 Panel, Acusign…Princeton BioMeditech Corp. · 1999
This deviceK014192 Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met…Princeton BioMeditech Corp. · 2002
Descendant · cites it directly · 0 of its ownK023837 Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma…Princeton BioMeditech Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all

K023837Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma…Princeton BioMeditech Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990786	Accusign Doa 10, Accusign Doa 10 Panel, Acusign…	Princeton BioMeditech Corp.	1999	—
0 (this device)	K014192	Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met…	Princeton BioMeditech Corp.	2002	—
+1	K023837	Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik…	Princeton BioMeditech Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K014192, 1999–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MVO? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K990786	Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp… Summary page 1 …tamine in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC) Identification of legally marketed device to which claims equivalence: k990786; Status DS™DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) Device Description: Life Sign® Home Drug Test (MET) is simple one st…	Princeton BioMeditech Corp.	1999	—

Also cleared against K990786: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023837	Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma…	Princeton BioMeditech Corp.	2003	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?

Its one ancestor has no recall.
Of its descendants, K023837 (Princeton BioMeditech Corp., 2003) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K990786.

How does its category compare?

All MVO devices

MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVO

FDA has decided no MVO device since 2007.

Median 510(k) review, days · MVO

Too few MVO 510(k)s in any year since 2007 to give a median.

Recalls per year · MVO

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MVO

1in 2015

2007high 3 (2013) · low 0 (2010)2025

MAUDE reports naming product code MVO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	1
2009	—	0	2
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	3
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	1	—

What is it indicated for?

Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place.

For In vitro Diagnostic Use

Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014192 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014192: Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014192

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026