BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
Device Facts
| Record ID | K180878 |
|---|---|
| Device Name | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx |
| Applicant | Shanghai Venture Bio-Tech Co., Ltd. |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Dec 17, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Drug Identifier Cut-off Level Amphetamine(AMP) 1000ng/mL Oxazepam 300 ng/mL Cocaine(COC) 300 ng/mL Marijuana(THC) 50 ng/mL Methamphetamine(MET) 1000 ng/mL Morphine 300 ng/mL The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use. BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Drug Identifier Cut-off Level Amphetamine(AMP) 1000ng/mL Oxazepam 300 ng/mL Cocaine(COC) 300 ng/mL Marijuana(THC) 50 ng/mL Methamphetamine(MET) 1000 ng/mL Morphine 300 ng/mL The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter use.
Device Story
Lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Cassette format houses single drug test strip. Principle: competitive binding; target drugs in urine compete with immobilized drug-conjugate for binding sites on gold-conjugated monoclonal antibodies. Absence of test line indicates positive result (drug concentration exceeds cutoff); presence of test line indicates negative result. Control line confirms proper migration. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires confirmatory testing via GC/MS for clinical decision-making. Benefits: rapid, qualitative screening for drug presence.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated across 3 lots with 6 operators over 25 days. Analytical specificity (cross-reactivity and interference) and matrix effects (pH, specific gravity) demonstrated. Lay user study (n=840) confirmed ease of use and performance across diverse demographics. Method comparison against GC/MS performed for all analytes.
Technological Characteristics
Lateral flow immunochromatographic assay; mouse monoclonal antibodies on gold-conjugated nanoparticles; anti-IgG polyclonal antibody control line. Single-use cassette format. No external energy source. Stable at 2-30°C for 24 months.
Indications for Use
Indicated for qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH in human urine. Intended for prescription or over-the-counter use as a preliminary screening tool. Requires confirmatory testing (GC/MS).
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
- INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) (k173303)
- INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (k173303)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k180878
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine
D. Type of Test:
Qualitative, lateral flow immunochromatographic assay
E. Applicant:
Shanghai Venture Bio-Tech CO., Ltd.
F. Proprietary and Established Names:
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use
BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use
BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use
BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use
BIO-VENTURE Rapid Morphine Test Cassette for OTC Use
BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use
BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use
BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use
BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use
BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use
BIO-VENTURE Rapid Morphine Test Cassette for Rx Use
BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use
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G. Regulatory Information:
| Product Codes | Class II | Regulation Section | Regulation Name | Panel |
| --- | --- | --- | --- | --- |
| DKZ, NFT | | 862.3100 | Amphetamine Test System | Toxicology (91) |
| DIO, NFY | | 862.3250 | Cocaine and Cocaine metabolites test system | |
| JXM, NFV | | 862.3170 | Benzodiazepine test system | |
| DJC, NGG | | 862.3610 | Methamphetamine Test System | |
| DNK, NGI | | 862.3640 | Morphine Test System | |
| LDJ, NFW | | 862.3870 | Cannabinoid test system | |
H. Intended Use:
1. Intended use(s):
Refer to Indication for Use.
2. Indication(s) for use:
BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Drug Identifier | Cut-off Level |
| --- | --- |
| Amphetamine(AMP) | 1000ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine(COC) | 300 ng/mL |
| Marijuana(THC) | 50 ng/mL |
| Methamphetamine(MET) | 1000 ng/mL |
| Morphine | 300 ng/mL |
The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
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BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Drug Identifier | Cut-off Level |
| --- | --- |
| Amphetamine(AMP) | 1000ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine(COC) | 300 ng/mL |
| Marijuana(THC) | 50 ng/mL |
| Methamphetamine(MET) | 1000 ng/mL |
| Morphine | 300 ng/mL |
The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter use.
3. Special conditions for use statement(s):
The BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are for prescription use.
The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use are for over the counter use.
4. Special instrument requirements:
Not applicable.
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I. Device Description:
The BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use and the BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use differ in intended use (prescription use or over the counter use), but share the same test cassette, with each cassette housing only one of 6 different drug test strips (for the qualitative detection of d-Methamphetamine, Morphine, 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH, d-Amphetamine, Cocaine or Oxazepam in human urine).
The BIO-VENTURE test cassettes (noted in the above paragraph) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine, 11-Nor-Δ⁹-Tetrahydrocannabinol-9-COOH, d-Amphetamine, Cocaine and Oxazepam in human urine. The tests are available in single drug test cassette formats. BIO-VENTURE test cassettes are coated with mouse monoclonal antibodies, each raised against specific drug analytes (deposited on the test line), and a anti-IgG polyclonal antibody (deposited on the control line). The cassettes are provided in individual aluminum foil bags.
J. Substantial Equivalence Information:
1. Predicate device name(s):
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)
INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
2. Predicate 510(k) number(s):
k173303
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Devices | Predicate – k173303 |
| Intended Use | Same | For the qualitative determination of drugs of abuse in human urine. |
| Methodology | Same | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody |
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| Similarities | | |
| --- | --- | --- |
| Item | Candidate Devices | Predicate – k173303 |
| | | immunochemistry. |
| Specimen type | Same | Urine |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate – k173303 |
| Formats | Cassette | Cup |
# K. Standard/Guidance Document Referenced (if applicable):
None referenced.
# L. Test Principle:
The BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use and the BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use are rapid tests for the qualitative detection of Methamphetamine, Morphine, 11-Nor- $\Delta$ 9-Tetrahydrocannabinol-9-COOH, d-Amphetamine, Benzoylecgonine and Oxazepam in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates across the test strip by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, they will not saturate the binding sites of specific anti-target drug monoclonal mouse antibodies coated on gold-conjugated nanoparticles, allowing the antibody-coated nanoparticles to be captured by immobilized drug-conjugate on the test line, and a visible colored line will show up in the test line region. The colored line in the test line region will not form if the target drug level exceeds its cutoff concentration because it will saturate all the binding sites of the antibody-coated nanoparticles, thus competing for binding to the test line region.
A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that sample has migrated past the test and control line regions.
# M. Performance Characteristics (if/when applicable):
1. Analytical performance:
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a. Precision/Reproducibility:
The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use are identical physical devices to the BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use, but have different labeling appropriate for OTC users. Precision testing was conducted using the The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use devices, but represents expected performance from both the Rx and OTC devices.
Precision was evaluated by analyzing spiked urine samples at concentrations of -100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, and +100%. Three lots were evaluated and the results were read by six operators, each operator performs 9 samples for 25 days in a randomized order. Results were as follows:
Methamphetamine:
| MET | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Morphine:
| MOP | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 17-/33+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 15-/35+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Marijuana:
| THC | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 36-/14+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38-/12+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 35-/15+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Amphetamine:
| AMP | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cocaine:
| COC | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxazepam:
| OXAZ | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable. These devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
This device has internal process controls. A control line appears in the control region confirming that sufficient sample volume has been applied to the test strip and that the sample has migrated correctly on the test strip. Users are informed that the test is invalid if the colored line does not appear in the control
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region. There are no external controls supplied with the device.
The sponsor claims that the devices are stable at 2-30 °C for 24 months based on a real time stability study at room temperature.
d. Detection limit:
Not applicable.
e. Analytical specificity:
The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use are identical physical devices to the BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use, but have different labeling appropriate for OTC users. Cross reactivity and interference testing was conducted using the The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use devices, but represents expected cross-reactivity and interference performance from both the Rx and OTC devices.
Cross-reactivity:
Cross-reactivity was evaluated by spiking in potential cross-reactants and titrating down to find the lowest concentration of cross-reactant that produced a positive result with the assays. The percent cross-reactivity was calculated as:
(cutoff concentration / lowest concentration causing a positive result) x 100
Results are summarized below.
Methamphetamine
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| D-Amphetamine | 100,000 | 1 |
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| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| L-Amphetamine | 100,000 | 1 |
| D/L-Amphetamine | 100,000 | 1 |
| p-Hydroxyamphetamine | 50,000 | 2 |
| MDA | 20,000 | 5 |
| MDMA | 3000 | 33.3 |
| MDEA | 5000 | 20 |
| D/L-Methamphetamine | 3000 | 33.3 |
| D-Methamphetamine | 1000 | 100 |
| L-Methamphetamine | 10,000 | 10 |
Morphine
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Acetylmorphine | 6000 | 5 |
| Hydromorphone | 3000 | 10 |
| Dimethylmorphine | 3000 | 10 |
| Hydrocodone | 50,000 | 0.6 |
| Oxycodone | 50,000 | 0.6 |
| Levorphanol | 1500 | 20 |
| Morphine-3- Glucuronide | >100,000 | <0.3 |
| Morphine | 300 | 100 |
| Codeine | 300 | 100 |
| Heroin | 300 | 100 |
| O^{6}- Monoacetylmorphine | 300 | 100 |
| Ethylmorphine | >100,000 | <0.3 |
Marijuana
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| (-)-11-Nor-Δ^{9}-Tetrahydrocannabinol-9-COOH | 50 | 100 |
| 11-Hydroxy-Δ^{9}-Tetrahydrocannabinol | 10,000 | 0.5 |
| 11-Nor-Δ^{8}-Tetrahydrocannabinol-9-COOH | 2500 | 2 |
| Cannabinol | 5000 | 1 |
| 11-Nor-Δ^{9}-THC-carboxy glucuronide | 5000 | 1 |
| (-)-11-nor-9-carboxy-Δ^{9}-THC | 10,0000 | 0.5 |
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10
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Δ^{8}-Tetrahydrocannabinol | >50,000 | 0.1 |
| Δ^{9}-Tetrahydrocannabinol | >50,000 | 0.1 |
| Cannabidiol | >50,000 | 0.1 |
## Amphetamine
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| D-Amphetamine | 1000 | 100.0 |
| D/L-Amphetamine | 1500 | 66.7 |
| Hydroxyamphetamine | 10,000 | 10.0 |
| Phentermine | 3000 | 33.3 |
| MDA | 10,000 | 10.0 |
| MDMA | >100,000 | <1 |
| MDE | >100,000 | <1 |
| Ephedrine | >100,000 | <1 |
| Pseudoephedrine | >100,000 | <1 |
| D/L-Methamphetamine | >100,000 | <1 |
| D-Methamphetamine | >100,000 | <1 |
| L-Amphetamine | 3000 | 33.3 |
## Cocaine
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Cocaine HCl | 5000 | 6 |
| Norcocaine | 25,000 | 1.2 |
| Ecgonine HCl | 50,000 | 0.6 |
| Benzoylecgonine | 300 | <0.3 |
| Cocaethylene | >100,000 | 100 |
## Oxazepam
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Diazepam | 1000 | 30 |
| Alprazolam | 1000 | 30 |
| α-Hydroxyalprazolam | 5000 | 6 |
| Bromazepam | 10000 | 3 |
| Chlordiazepoxide | 10000 | 3 |
| Clobazam | 500 | 60 |
| Clonazepam | 3000 | 10 |
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11
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Delorazepam | 5000 | 6 |
| Estazolam | 10000 | 3 |
| Flunitrazepam | 5000 | 6 |
| Midazolam | 50000 | 0.6 |
| Nitrazepam | 500 | 60 |
| Nordiazepam | 5000 | 6 |
| Temazepam | 500 | 60 |
| Triazolam | 10000 | 3 |
| Lorazepam | 25000 | 1.2 |
| Oxazepam | 300 | 100 |
| Clorazepate dipotassium | >100,000 | <0.3 |
| Desalkylflurazepam | >100,000 | <0.3 |
| Norchlordiazepoxide | >100,000 | <0.3 |
## Interferences:
Interference was evaluated by spiking the potential interferents below into urine samples at $\pm 25\%$ of the cut-off for the AMP, COC, BNZ, MET, MOP, and THC assays.
All potential interferents were tested at a concentration of $100~\mu \mathrm{g/mL}$ except for THC which was tested at $10~\mu \mathrm{g/mL}$ and $1\%$ Ethanol. There were no deviations from the expected results for any of the three formats.
## Methamphetamine
| Methadone | Naltrexone | Naloxone | Morphine |
| --- | --- | --- | --- |
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Diazepam |
| Dextromethorphan | Cocaine | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Cholesterol | Ethanol | |
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Morphine
| Methadone | Naltrexone | Naloxone | Cocaine |
| --- | --- | --- | --- |
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Cholesterol | Hydrocortisone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Amphetamine | MDMA | Ethanol |
THC
| Methadone | Naltrexone | Naloxone | Morphine |
| --- | --- | --- | --- |
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
| Acetaminophen | Cocaine | Amphetamine | MDMA |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Cholesterol | Hydrocortisone | Oxycodone |
| Ethanol | | | |
AMP
| Methadone | Naltrexone | Naloxone | Morphine |
| --- | --- | --- | --- |
| Gatifloxacin | Procaine | Amitriptyline | Chlorpheniramine Maleate |
| Promethazine | Amoxicillin | Methoxyphenamine | Ketamine Hydrochloride |
| Ranitidine | Tramadol | Buprenorphine | Phenobarbital |
| Nifedipine | Diazepam | Dextromethorphan | Cocaine |
| Theophylline | Aspirin | Acetaminophen | Δ9-THC |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
{12}
13
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| --- | --- | --- | --- |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Cholesterol | Hydrocortisone | Oxycodone |
| Ethanol | | | |
Oxazepam
| Methadone | Naltrexone | Naloxone | Morphine |
| --- | --- | --- | --- |
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Cocaine | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| MDMA | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Cholesterol | Amphetamine | Ethanol |
Cocaine
| Methadone | Naltrexone | Naloxone | Morphine |
| --- | --- | --- | --- |
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Secobarbital | Angiotensin | Adrenaline | Oxalic Acid |
| Oxazepam | Uric Acid | Triglyceride | Prednisolone acetate |
| Cholesterol | MDMA | Amphetamine | Ethanol |
The effect of pH was evaluated by preparing samples at $\pm 25\%$ of the cutoff for the MET, MOR, THC, AMP, COC, and OXAZ assays and adjusting the pH to 4.00 to 9.00, in increments of $1\mathrm{pH}$ unit. There were no deviations from the expected results.
The effect of specific gravity was evaluated by preparing samples at $\pm 25\%$ of
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the cutoff for the MET, MOR, THC, AMP, COC, and OXAZ assays and adjusting the specific gravity to 1.002, 1.016, 1.018, 1.023, 1.033, and 1.036. There were no deviations from the expected results.
f. Assay cut-off:
For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to section M.1.a., above.
2. Comparison studies:
a. Method comparison with predicate device:
The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use are identical physical devices to the BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use, but have different labeling appropriate for OTC users. Method comparison testing was conducted using the The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use devices, but represents expected performance from both the Rx and OTC devices.
Method comparison studies for the BIO-VENTURE Rapid Single Drug Test Cassettes for Amphetamine, Oxazepam, Cocaine and Cocaine metabolites, Marijuana, Methamphetamine, Morphine were performed in-house with three laboratory assistants for each device. Operators ran unaltered clinical samples; 87 samples for amphetamine, 80 samples for cocaine, 80 samples for Oxazepam, 81 samples for Methamphetamine, 81 samples for Morphine and 82 samples for Marijuana. The samples were blind-labeled and compared to results obtained by GC/MS. The results are presented in the tables below:
14
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15
| Methamphetamine – Cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
| Operator 2 | Negative | 17 | 16 | 8 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 8 | 29 |
| Operator 3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
Discordant results
| Drug in urine | | Operator | Cut-off (ng/mL) | GC/MS results(ng/mL) | Test results |
| --- | --- | --- | --- | --- | --- |
| Methamphetamine | 2 | 1000 | 1025 | - | |
| | | | 2 | 1033 | - |
| | | | 1 | 984 | + |
| | | | 3 | 984 | + |
| | | | 2 | 1055 | - |
| Morphine – Cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
| Operator 2 | Negative | 19 | 9 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 12 | 25 |
| Operator 3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
{15}
Discordant results
| Drug in urine | Operator | Cut-off (ng/mL) | GC/MS results(ng/mL) | Test results |
| --- | --- | --- | --- | --- |
| Morphine | 2 | 300 | 323 | - |
| | 2 | | 325 | - |
| | 2 | | 335 | - |
| | 1 | | 293 | + |
| | 3 | | 293 | + |
| THC Cassette | | Negative | <-50% cut off | -50% cut off~cut off | Cut off~+50% cut off | >+50% cut off |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Negative | 18 | 11 | 13 | 4 | 0 |
| | Positive | 0 | 0 | 0 | 12 | 24 |
| Operator 2 | Negative | 18 | 11 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 24 |
| Operator 3 | Negative | 18 | 11 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 15 | 24 |
Discordant results
| Drug in urine | Operator | Cutoff(ng/mL) | GC/MS Results (ng/mL) | Test Results |
| --- | --- | --- | --- | --- |
| Marijuana | 1 | 50 | 61 | - |
| | 1 | | 59 | - |
| | 3 | | 59 | - |
| | 1 | | 61 | - |
| | 1 | | 59 | - |
| Amphetamine- cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 19 | 16 | 11 | 1 | 0 |
| | Negative | 0 | 0 | 0 | 13 | 27 |
| Operator 2 | Positive | 19 | 16 | 10 | 1 | 0 |
| | Negative | 0 | 0 | 1 | 13 | 27 |
| Operator 3 | Positive | 19 | 16 | 10 | 0 | 0 |
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17
| Amphetamine- cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| | Negative | 0 | 0 | 1 | 14 | 27 |
Discordant results
| Drug in urine | Operator | Cut-off (ng/mL) | GC/MS results(ng/mL) | Test results |
| --- | --- | --- | --- | --- |
| Amphetamine | 2 | 1000 | 989 | + |
| | 3 | | 989 | + |
| | 2 | | 1035 | - |
| | 1 | | 1062 | - |
| Oxazepam - cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 15 | 10 | 15 | 0 | 0 |
| | Negative | 0 | 0 | 0 | 20 | 20 |
| Operator 2 | Positive | 15 | 10 | 13 | 0 | 0 |
| | Negative | 0 | 0 | 2 | 20 | 20 |
| Operator 3 | Positive | 15 | 10 | 13 | 0 | 0 |
| | Negative | 0 | 0 | 2 | 20 | 20 |
Discordant results
| Drug in urine | Operator | Cut-off (ng/mL) | GC/MS results(ng/mL) | Test results |
| --- | --- | --- | --- | --- |
| Oxazepam | 2 | 300 | 283 | + |
| | 2 | | 288 | + |
| | 3 | | 288 | + |
| | 3 | | 298 | + |
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| Cocaine - cassette | | Negative | (less than -50% by LC/MS) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 18 | 13 | 11 | 0 | 0 |
| | Negative | 0 | 0 | 0 | 17 | 21 |
| Operator 2 | Positive | 18 | 13 | 9 | 0 | 0 |
| | Negative | 0 | 0 | 2 | 17 | 21 |
| Operator 3 | Positive | 18 | 13 | 9 | 0 | 0 |
| | Negative | 0 | 0 | 2 | 17 | 21 |
Discordant results
| Drug in urine | Operator | Cut-off (ng/mL) | GC/MS results(ng/mL) | Test results |
| --- | --- | --- | --- | --- |
| Cocaine | 2 | 300 | 278 | + |
| | 3 | | 278 | + |
| | 2 | | 285 | + |
| | 3 | | 285 | + |
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
A lay user study was conducted to assess the BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, and BIO-
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VENTURE Rapid Marijuana Test Cassette for OTC Use devices with 840 lay persons with diverse educational and professional backgrounds and ranging in age from 20 to <50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS, and the results provided below are from each lay user, who tested only one device at one test concentration. Lay-users were also given surveys on the ease of understanding the package insert instructions (Flesch-Kincaid reading analysis revealed a reading Grade Level of 7 for the device labeling). All lay users indicated that the device instructions could be easily followed.
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use
| % of cut off | Number of samples | d-Amphetamine Concentration by GC/MS(ng/mL) | Number of Positive | Number of Negative | Percentage of Correct Results (%) |
| --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 248 | 0 | 20 | 100% |
| -50% cut off | 20 | 492 | 0 | 20 | 100% |
| -25% cut off | 20 | 741 | 2 | 18 | 90% |
| +25% cut off | 20 | 1262 | 19 | 1 | 95% |
| +50% cut off | 20 | 1506 | 20 | 0 | 100% |
| +75% cutoff | 20 | 1744 | 20 | 0 | 100% |
BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use
| % of cut off | Number of samples | Cocaine Concentration by GC/MS(ng/mL) | Number of Positive | Number of Negative | Percentage of Correct Results(%) |
| --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 62 | 0 | 20 | 100% |
| -50% cut off | 20 | 135 | 0 | 20 | 100% |
| -25% cut off | 20 | 212 | 2 | 18 | 90% |
| +25% cut off | 20 | 365 | 20 | 0 | 100% |
| +50% cut off | 20 | 444 | 20 | 0 | 100% |
| +75% cut off | 20 | 533 | 20 | 0 | 100% |
{19}
BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use
| % of cut off | Number of samples | Oxazepam Concentration by GC/MS(ng/mL) | Number of Positive | Number of Negative | Percentage of Correct Results(%) |
| --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 64 | 0 | 20 | 100% |
| -50% cut off | 20 | 141 | 0 | 20 | 100% |
| -25% cut off | 20 | 221 | 1 | 19 | 95% |
| +25% cut off | 20 | 362 | 20 | 0 | 100% |
| +50% cut off | 20 | 440 | 20 | 0 | 100% |
| +75% cut off | 20 | 530 | 20 | 0 | 100% |
BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use
| % of cut off | Number of samples | d-Methamphetamine Concentration by GC/MS(ng/mL) | | Number of Positive | Number of Negative | Percentage of Correct Results (%) |
| --- | --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% | |
| -75% cut off | 20 | 248 | 0 | 20 | 100% | |
| -50% cut off | 20 | 489 | 0 | 20 | 100% | |
| -25% cut off | 20 | 734 | 2 | 18 | 90% | |
| +25% cut off | 20 | 1284 | 20 | 0 | 100% | |
| +50% cut off | 20 | 1535 | 20 | 0 | 100% | |
| +75% cut off | 20 | 1783 | 20 | 0 | 100% | |
BIO-VENTURE Rapid Morphine Test Cassette for OTC Use
| % of cut off | Number of samples | Morphine Concentration by GC/MS(ng/mL) | Number of Positive | Number of Negative | Percentage of Correct Results(%) |
| --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 70 | 0 | 20 | 100% |
| -50% cut off | 20 | 136 | 0 | 20 | 100% |
| -25% cut off | 20 | 228 | 2 | 18 | 90% |
| +25% cut off | 20 | 378 | 20 | 0 | 100% |
| +50% cut off | 20 | 445 | 20 | 0 | 100% |
| +75% cut off | 20 | 510 | 20 | 0 | 100% |
{20}
BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use
| % of cut off | Number of samples | Marijuana Concentration by GC/MS(ng/mL) | Number of Positive | Number of Negative | Percentage of Correct Results(%) |
| --- | --- | --- | --- | --- | --- |
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 10 | 0 | 20 | 100% |
| -50% cut off | 20 | 24 | 0 | 20 | 100% |
| -25% cut off | 20 | 36 | 0 | 20 | 100% |
| +25% cut off | 20 | 60 | 20 | 0 | 100% |
| +50% cut off | 20 | 73 | 20 | 0 | 100% |
| +75% cut off | 20 | 82 | 20 | 0 | 100% |
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
