510(k) · Cleared
ClearedLifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · LAF Gas Chromatography, Methamphetamine
Cleared on Sep 15, 2003 as substantially equivalent to K014193 (Princeton BioMeditech Corp., 2002) and 1 other predicate after a 301-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 15, 2003
- Review
- 301 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981771 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK981771 Accusign Mop, Biosign Mop, Staus DS MopPrinceton BioMeditech Corp. · 1998
- 1 generation backK014193 Lifesign Doa 4 (THC/Opi/Coc/Met)Princeton BioMeditech Corp. · 2002
- This deviceK023837 Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma…Princeton BioMeditech Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981771 | Accusign Mop, Biosign Mop, Staus DS Mop | Princeton BioMeditech Corp. | 1998 | — |
| −1 | K014193 | Lifesign Doa 4 (THC/Opi/Coc/Met) | Princeton BioMeditech Corp. | 2002 | — |
| 0 (this device) | 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 |
| 2002 | 1 | 0 |
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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014193 | Lifesign Doa 4 (THC/Opi/Coc/Met)Summary page 1…that GUMS is the preferred confirmatory method. 7. Substantial Equivalence: Status StikTM THC/OPI/COC/MET & MDMA is substantially equivalent to the k014193, Status StikTMTHC/OPI/COC/MET. Both products use the same assay principle and are inmunochromatographic assays to detect THC… | 2002 |
| Kept off the family tree | K014092 | Status Stik MET Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…result and that GC/MS is the preferred confirmatory method. 7. Substantial Equivalence: Status Stik" MET & MDMA is substantially equivalent to the k014092, Status Stik'" MET. Both products use the same assay principle and immunochromatographic assay to detect methamph… | |
| * | K014192 | Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS…Summary page 5…s of Abuse Analysis Systems, Toxicology (9 1LAG for HPLC) 4. Identification of legally marketed device to which claims equivalence: k014192 Life Sign@Home Drug Test (MET) 5. Device Description: Life Sign@HomeDrug Test… | 2002 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 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 and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GCMS is the preferred confirmatory method. Immunoassay for the…
Read the full statement (325 words)
Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GCMS is the preferred confirmatory method.
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine 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 ngl mL
COC Benzoylecgonine 300 ngl mL
MET D-Methamphetamine 500 ngl mL
MDMA 3,4-Methylenedioxymethamphetamine 500 ngl mL
This test provides only-.a preliminary analytical result and a more specific alternative chemical method must be used tc; obtain a confirmed analytical result and that GUMS is the preferred confirmatory method.
Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GCMS is the preferred confirmatmy method.
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine 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-A9-THC-9-carboxylicacid 50 ng/ mL
OP I Morphine 2000 ng/ mL
COC Benzoylecgonine 300 ng/ mL
MET D-Methamphetamine 500 ng/ mL
MDMA 3,4-methylenedioxymethamphetamine 500 ng/mL
This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GUMS is the preferred confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023837: Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023837
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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