LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA

K023837 · Princeton BioMeditech Corp. · LAF · Sep 15, 2003 · Clinical Toxicology

Device Facts

• Record ID: K023837
• Device Name: LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
• Applicant: Princeton BioMeditech Corp.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

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)

{0}

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.

{1}

Page 2 of 6

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.

{2}

Page 3 of 6

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 |

{4}

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

{5}

Page 6 of 6

| + 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.