510(k) · Cleared

Cleared

Lifesign Doa 4 (THC/Opi/Coc/Met)

K014193510(k) TraditionalCleared May 23, 2002153-day reviewClass II21 CFR 862.3870

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

Princeton BioMeditech Corp. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on May 23, 2002 as substantially equivalent to K990786 (Princeton BioMeditech Corp., 1999) and 1 other predicate after a 153-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: May 23, 2002
Review: 153 days
Class: Class II
Product code: LDJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K981771 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981771 Accusign Mop, Biosign Mop, Staus DS MopPrinceton BioMeditech Corp. · 1998
This deviceK014193 Lifesign Doa 4 (THC/Opi/Coc/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	K981771	Accusign Mop, Biosign Mop, Staus DS Mop	Princeton BioMeditech Corp.	1998	—
0 (this device)	K014193	Lifesign Doa 4 (THC/Opi/Coc/Met)	Princeton BioMeditech Corp.	2002	—
+1	K023837	Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik…	Princeton BioMeditech Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K014193, 1998–2003Source: 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 LDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LDJ device

#1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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 …91LAG for HPLC) 4. Identification of legally marketed dev1ce to which claims equivalence: For THC, COC, MET: Status DS DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/ MTD/TCA/AMP), k990786 For OPI: Status DS OPI, k981771 5. Device Description: Status Stik™ THC/OPI/COC/MET is simple one step immunochromatographic tes…	Princeton BioMeditech Corp.	1999	—
*	K981771	Accusign Mop, Biosign Mop, Staus DS Mop Summary page 1 …on of legally marketed dev1ce to which claims equivalence: For THC, COC, MET: Status DS DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/ MTD/TCA/AMP), k990786 For OPI: Status DS OPI, k981771 5. Device Description: Status Stik™ THC/OPI/COC/MET is simple one step immunochromatographic test for the rapid, qualitative, si…	Princeton BioMeditech Corp.	1998	—

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?

None of the 2 ancestors has a 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 LDJ devices

LDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDJ

2in 2024

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDJ

48in 2015

2007high 219 (2011) · low 48 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LDJ

1in 2023

2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LDJ

1in 2015

2007high 1 (2015) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	2	—	4	0
2009	1	—	0	0
2010	0	—	0	0
2011	4	219	0	0
2012	4	193	0	0
2013	3	162	0	0
2014	2	—	0	0
2015	3	48	0	1
2016	1	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	1	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	1	0
2024	2	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use The detection cutoff concentrations are as follows: THC 11-nor-A°’-THC-9-carboxylic acid 50 ng/ml OPI Morphine 2000 ng/ml COC Benzoylecgonine 300 ng/ml MET D-Methamphetamine 1000 ng/ml Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine…

Read the full statement (108 words)

Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use

The detection cutoff concentrations are as follows:

THC 11-nor-A°’-THC-9-carboxylic acid 50 ng/ml

OPI Morphine 2000 ng/ml

COC Benzoylecgonine 300 ng/ml

MET D-Methamphetamine 1000 ng/ml

Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows:

THC 11-nor-A°>-THC-9-carboxylic acid 50 ng/ml

OPI Morphine 2000 ng/ml

COC Benzoylecgonine 300 ng/ml

MET D-Methamphetamine 1000 ng/ml

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/K014193 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014193: Lifesign Doa 4 (THC/Opi/Coc/Met).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014193

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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