Method comparison with predicate device; Retrospective method comparison study
Clinical urine samples (negative samples from individuals not taking medication; positive samples from a toxicology laboratory); Sample Size: More than 50 negative and 40 positive samples; Number of Sites: 1 (manufacturer's site)
GC/MS
Qualitative detection of methamphetamine and MDMA
Indications for Use
Status Stik™ MET & MDMA, Accusign® Stik MET & MDMA, Accustik® Met & MDMA, Accusign® MET & MDMA, Status DS™ MET & MDMA and Accustrip™ MET & MDMA are immunoassays for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cutoff of 500 ng/ml in urine to assist in screening of drugs of abuse samples. The devices are for prescription use. Lifesign Home Drug Test (Ecstasy&MET) is for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cutoff of 500 ng/ml in urine to assist in screening of drugs of abuse samples at home and workplace. Status Stik™ THC/OPI/COC/MET & MDMA, Accusign® Stik THC/OPI/COC/MET & MDMA, Accustik® DOA 4, Status DS™ DOA 4, Accusign® DOA 4 and Accustrip™ DOA 4 are immunoassays 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. The detection cutoff concentrations are 50 ng/ml for THC, 2000 ng/ml for morphine, 300 ng/ml for benzylecgonine, 500 ng/ml for methamphetamine, 500 ng/ml for 3,4-methylenedioxymethamphetamine. These devices are for prescription use. Lifesign Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) is an 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 workplace. The detection cutoff concentrations are 50 ng/ml for THC, 2000 ng/ml for morphine, 300 ng/ml for benzylecgonine, 500 ng/ml for methamphetamine, 500 ng/ml for 3,4-methylenedioxymethamphetamine.
Device Story
Unitized immunochromatographic assay (dipstick, dip card, or dipstrip) for qualitative detection of drugs of abuse in urine; utilizes lateral flow immunoassay principle; detects methamphetamine and MDMA via single test line (cannot distinguish between them). Home use versions include materials for GC/MS confirmation. Used in clinical, home, or workplace settings; operated by healthcare professionals or lay users. Provides preliminary analytical results; requires confirmatory testing (GC/MS) for definitive diagnosis. Assists in screening decisions; clinical judgment required for interpretation.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated using spiked urine samples across three formats. Consumer study (n=251, ages 18-45+) confirmed lay user ability to perform and interpret tests. Method comparison against GC/MS performed on >50 negative and 40 positive samples; results demonstrated concordance with GC/MS near cutoff concentrations. No clinical studies submitted.
Technological Characteristics
Visually-read lateral flow immunochromatographic assay. Formats: dipstick, dip card, dipstrip. Analyte detection via antibody-antigen binding. Qualitative output. No instrumentation required. Not networked/standalone.
Indications for Use
Indicated for qualitative detection of methamphetamine, MDMA, THC, opiates, and cocaine metabolites in urine for drug screening. Prescription use for professional settings; home/workplace use for Lifesign versions. Cutoffs: 500 ng/mL (meth/MDMA), 50 ng/mL (THC), 2000 ng/mL (morphine), 300 ng/mL (benzylecgonine).
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
Status Stik™ THC/OPI/COC/MET (k014193)
Status Stik™ MET (k014092)
LifeSign® Home Drug Test (THC/OPI/COC/MET) (k014193)
LifeSign® Home Drug Test (MET) (k014192)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number: K023837
B. Analyte: methamphetamines (methamphetamine or MDMA), cocaine, cannabinoids, opiates.
C. Type of Test: qualitative, visually-read, immunochromatographic assay
D. Applicant: Princeton Biomeditech Corporation
E. Proprietary and Established Names: Lifesign® Home Drug Test (Ecstasy&MET), Status Stik™ MET & MDMA, Accusign® Stik MET and MDMA, Accustik® Met & MDMA, Accusign® MET & MDMA, Status DS™ MET & MDMA, Accustrip Met & MDMA, Lifesign® Home Drug Test (Marijuana, Opiates, Cocaine, Ecstasty&MET), Status Stik™ THC/OPI/COC/MET & MDMA, Accusign® Stik THC/OPI/COC/MET & MDMA, Accustik® DOA 4, Accusign® DOA 4, Status DS™ DOA 4, Accustrip DOA 4
F. Regulatory Information:
1. Regulation section: 21CFR862.3610 Methamphetamine Test System, 21CFR862.3870 Cannabinoid Test System, 21CFR862.3650 Opiate Test System, 21CFR862.3250 Cocaine and Cocaine Metabolite Test System.
2. Classification: Class II
3. Product Code: LAF, LDJ, DJG, DIO
4. Panel: Toxicology (91)
G. Intended Use:
1. Indication(s) for use:
Status Stik™ MET & MDMA, Accusign® Stik MET & MDMA, Accustik® Met & MDMA, Accusign® MET & MDMA, Status DS™ MET & MDMA and Accustrip™ MET & MDMA are immunoassays for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cutoff of 500 ng/ml in urine to assist in screening of drugs of abuse samples. The devices are for prescription use.
Lifesign Home Drug Test (Ecstasy&MET) is for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cutoff of 500 ng/ml in urine to assist in screening of drugs of abuse samples at home and workplace.
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Status Stik™ THC/OPI/COC/MET & MDMA, Accusign® Stik
THC/OPI/COC/MET & MDMA, Accustik® DOA 4, Status DS™ DOA 4,
Accusign® DOA 4 and Accustrip™ DOA 4 are immunoassays 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. The detection cutoff concentrations are 50 ng/ml for THC, 2000 ng/ml for
morphine, 300 ng/ml for benzylecgonine, 500 ng/ml for methamphetamine, 500
ng/ml for 3,4-methylenedioxymethamphetamine. These devices are for
prescription use.
Lifesign Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) is an
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 workplace. The
detection cutoff concentrations are 50 ng/ml for THC, 2000 ng/ml for morphine,
300 ng/ml for benzylecgonine, 500 ng/ml for methamphetamine, 500 ng/ml for
3,4-methylenedioxymethamphetamine.
2. Special condition for use statement(s): 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
spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any drug of abuse
test result, particularly when preliminary positive results are used.
The assay detects methamphetamine or MDMA using one test line. (It does not
distinguish between the two drugs.)
The Status Stik™, Accusign® Stik, Accustik®, Accusign®, Status DS™ and
Accustrip™ tests listed above are indicated for prescription use. The Lifesign
Home Drug tests are indicated for home or workplace use.
3. Special instrument Requirements: none
H. Device Description:
The devices are unitized, visually-read immunochromatographic assays in formats of
dipstick, dip card or dipstrip. The home use version of the device is in dip card
format and also contains material for obtaining GCMS confirmation of preliminary
results.
I. Substantial Equivalence Information:
1. Predicate device name(s): Lifesign® Home Drug Test
(THC/OPI/COC/MET), Status Stik™ THC/OPI/COC/MET, Accusign® Stik
THC/OPI/COC/MET, Accustik™ DOA 4, Accusign® DOA 4, Status DS™ DOA
4, Accustrip™ DOA 4.
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Lifesign® Home Drug Test MET, Status Stik™ MET, Accusign® Stik MET, Accustik™ MET, Accusign® MET, Status DS™ MET, Accustrip™ MET.
2. Predicate K number(s): K014192, K014193
3. Comparison with predicate: The operating principle is similar to the predicate device. The change to the device includes changes to an antibody so that it is equally sensitive to both MDMA and methamphetamine and addition of MDMA detection to the indications for use. The cutoff concentration level for both MDMA and methamphetamine are 500 ng/ml for this device. The methamphetamine cutoff level was 1000 ng/ml for the predicate device.
J. Standard/Guidance Document Referenced (if applicable):
K. Test Principle: The test is a visually read lateral flow immunoassay.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Assay cutoff and precision were evaluated for all three formats of the professional use devices. A pooled negative urine solution was spiked with commercial drug material. Three operators each tested 40 samples at each drug level. Testing was conducted over 2 days and included two device lots. A summary of results from that evaluation is shown below:
| concentration (ng/ml) | % correct results | % correct results |
| --- | --- | --- |
| | methamphetamine | MDMA |
| 0 | 100 | 100 |
| 250 | 95-100 | 98-100 |
| 375 | 75-90 | 70-90 |
| 625 | 73-93 | 75-90 |
| 750 | 95-100 | 95-100 |
| 1000 | 100 | 100 |
A lay user consumer study was performed on the Lifesign Home Drug Test to evaluate whether lay users can perform and interpret the test correctly using spiked urine samples. Participants were given a spiked sample ( of a concentration unknown to the participant), a test device and a package insert. There were 251 participants ranging in age from 18 to over 45. Education levels of participants ranged from non-high school graduates (n=16) through graduate school graduates (n=81). An additional survey filled out by the participants indicated that users understood how to interpret results, including the description of a preliminary results and how to obtain confirmatory results.
{3}
Samples used in the consumer study were prepared by spiking commercial drug standard solution into pooled negative urine. The following were the results of the consumer study for methamphetamine and MDMA using spiked samples:
| methamphetamine(ng/ml) | # samples tested | % correct answers |
| --- | --- | --- |
| 125 | 11 | 100 |
| 250 | 34 | 100 |
| 375 | 12 | 83 |
| 625 | 14 | 79 |
| 750 | 31 | 97 |
| 875 | 10 | 100 |
| 1000 | 10 | 100 |
| MDMA( ng/ml) | # samples tested | % correct answers |
| --- | --- | --- |
| 125 | 10 | 100 |
| 250 | 34 | 97 |
| 375 | 18 | 72 |
| 625 | 16 | 75 |
| 750 | 31 | 97 |
| 875 | 12 | 100 |
| 1000 | 11 | 100 |
b. Linearity/assay reportable range: Not applicable. This is a qualitative test.
c. Traceability (controls, calibrators, or method): Control materials are available commercially for the professional use test.
d. Detection limit: See assay cutoff section below
e. Analytical specificity: To evaluate cross-reactivity with related drugs, the compounds listed below were added to drug free urine, which was serially diluted (1:1) and tested with the device. Concentrations at which cross-reactivity was observed are shown below:
| Compound | Cross-reacting level (ng/ml) |
| --- | --- |
| D-amphetamine | 100,000 |
| D-,L-Amphetamine | 100,000 |
| (-) Ephedrine | 100,000 |
| (+/-) Ephedrine | 100,000 |
| D-Methamphetamine | 500 |
| Methylenedioxyamphetamine | 50,000 |
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Page 5 of 6
Interference was evaluated by spiking over-the-counter and prescription drugs into drug-free urine to a concentration of 100 ug/ml. The list of drugs tested is included in the package insert. No unusual interference was observed.
The effect of pH (across the range 4.7-8.0) and specific gravity (across the range 1.002-1.04) was evaluated. Urine samples across these ranges were prepared and spiked with methamphetamine or MDMA at levels of 250 and 1000 ng/ml. Variations in pH and specific gravity across these ranges had no effect on the test results observed.
f. Assay cut-off: See precision section above.
2. Comparison studies:
a. Method comparison with predicate device:
Comparison to GCMS was evaluated at the manufacturer's site for more than 50 negative and 40 positive samples. Negative samples were obtained from individuals who had not been taking any medication other than multivitamins. Positive samples were randomly selected retrospective samples from a toxicology laboratory, determined positive by GCMS. Some samples were diluted in order to attain near-cutoff concentrations. Results are shown below for methamphetamine and MDMA:
Method Comparison Tables
GCMS
| + Status/ MDMA - | + | + (within 25% above the cutoff concentration) | - (within 25% below the cutoff concentration) | - |
| --- | --- | --- | --- | --- |
| | 50 | 11 | 2 | 0 |
| | 0 | 2 | 9 | 50 |
GCMS
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| + Status/ MDMA - | + | + (within 25% above the cutoff concentration) | - (within 25% below the cutoff concentration) | - |
| --- | --- | --- | --- | --- |
| | 31 | 8 | 3 | 0 |
| | 0 | 2 | 7 | 50 |
b. Matrix comparison: Not applicable. The device is indicated only for urine specimens.
3. Clinical studies:
a. Clinical sensitivity: Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity: Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):
4. Clinical cut-off: Not applicable. Clinical cutoff data is not typically provided for this device type.
5. Expected values/Reference range: Not applicable
M. Conclusion:
I recommend that the Princeton Biomeditech devices listed above are substantially equivalent to the predicate devices.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
