BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
Device Facts
| Record ID | K180879 |
|---|---|
| Device Name | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use |
| Applicant | Shanghai Venture Bio-Tech Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Dec 14, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, 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: Test Calibrators Cut-off Level Amphetamine (AMP) d-Amphetamine 1000ng/ml Oxazepam Oxazepam 300ng/ml Cocaine (COC) Benzoylecgonine 300ng/ml Methamphetamine (MET) d-Methamphetamine 1000ng/ml Morphine(MOP) Morphine 300ng/ml Marijuana (THC) Delta-9-THC-COOH 50ng/ml Easy cup test and Split Key Cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes. 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. BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay 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: Test Calibrators Cut-off Level Amphetamine (AMP) d-Amphetamine 1000ng/ml Oxazepam Oxazepam 300ng/ml Cocaine (COC) Benzoylecgonine 300ng/ml Methamphetamine (MET) d-Methamphetamine 1000ng/ml Morphine(MOP) Morphine 300ng/ml Marijuana (THC) Delta-9-THC-COOH 50ng/ml Easy cup test and split key cup test may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes. 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.
Device Story
Lateral flow immunochromatographic assay; detects d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH in human urine. Urine sample migrates via capillary action; target drugs compete with drug-conjugates for binding sites on monoclonal mouse antibody-coated particles. Absence of drug allows antibody-particle binding to immobilized drug-conjugate, forming visible colored test line; presence of drug saturates binding sites, preventing line formation. Control line confirms proper flow. Used in OTC or clinical settings; operated by lay users or healthcare professionals. Provides preliminary qualitative results; positive results require confirmation via GC/MS. Benefits patient by enabling rapid, point-of-care screening for drug presence.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical bench testing (precision, cross-reactivity, interference) and a lay user study (n=280) comparing device results to GC/MS-confirmed spiked urine samples. Results showed high concordance with GC/MS across all analytes at concentrations near the cutoff.
Technological Characteristics
Lateral flow immunochromatographic assay; qualitative; urine specimen; monoclonal mouse antibody-coated particles; immobilized drug-conjugate test lines; internal control line; shelf life 24 months at 2-30°C; no external controls provided; no instrumentation required.
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 OTC or prescription use to provide preliminary results; requires confirmatory testing (GC/MS).
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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:
k180879
B. Purpose for Submission:
New device
C. Measurand:
d-Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, and Marijuana
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 Multi-drug Test Easy Cup for OTC Use
BIO-VENTURE Rapid Multi-drug Test Split Key Cup for OTC Use
BIO-VENTURE Rapid Multi-drug Test Easy Cup for Rx Use
BIO-VENTURE Rapid Multi-drug Test Split Key Cup for Rx Use
G. Regulatory Information:
| Product Codes | Class | Regulation Section | Regulation Name | Panel |
| --- | --- | --- | --- | --- |
| DKZ, NFT | II | 862.3100 | Amphetamine Test System | Toxicology (91) |
| DIO, NFY | II | 862.3250 | Cocaine and cocaine metabolites test system | |
| JXM, NFV | II | 862.3170 | Benzodiazepine test system | |
| DJC, NGG | II | 862.3610 | Methamphetamine Test System | |
| DNK, NGI | II | 862.3640 | Morphine Test System | |
| LDJ, NFW | II | 862.3870 | Cannabinoid test system | |
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H. Intended Use:
1. Intended use(s):
Refer to Indication for Use
2. Indication(s) for use:
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup 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:
| Test | Calibrators | Cut-off Level |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana(THC) | Delta-9-THC-COOH | 50ng/ml |
Easy cup test and Split key cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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.
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup 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:
| Test | Calibrators | Cut-off Level |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
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Easy cup test and split key cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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.
3. Special conditions for use statement(s):
The BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use are intended for over the counter use.
The BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use are intended for prescription use.
4. Special instrument requirements:
Not applicable.
I. Device Description:
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and 11-Nor-Δ9-Tetrahydrocannabinol-9- COOH (target analytes) in human urine. The BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use devices consist of a cup that may be configured as single drug tests or multiple drug tests in any combination of the drug analytes up to a maximum of 6 analytes, and the BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use and the BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use devices consist of a split key cup that may be configured as a single drug test or multiple drug tests in any combination of the drug analytes up to 6 total. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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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:
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Same | For the qualitative determination of drugs of abuse in human urine. |
| Methodology | Same | Lateral flow immunochromatographic assays |
| Test Type | Same | Qualitative |
| Specimen Type | Same | Urine |
| Intended Users | Same | OTC Use |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Configurations | Easy Cup and Split Key Cup | Cup |
| Analytes | d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH | d-Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Methadone, Phencyclidine, Nortriptyline, 11-nor-Δ9-THC-9-COOH, Methylenedioxy-methamphetamine, Morphine, Oxycodone |
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BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Same | For the qualitative determination of drugs of abuse in human urine. |
| Methodology | Same | Lateral flow immunochromatographic assays |
| Test Type | Same | Qualitative |
| Specimen Type | Same | Urine |
| Intended Users | Same | Rx Use |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Configurations | Easy Cup and Split Key Cup | Cup |
| Analytes | d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH | d-Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Methadone, Phencyclidine, Nortriptyline, 11-nor-Δ9-THC-9-COOH, Methylenedioxy-methamphetamine, Morphine, Oxycodone |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. Test Principle:
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use and BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use are rapid tests for the qualitative detection of d-Amphetamine, Benzoylecgonine, Oxazepam, Methamphetamine, Morphine, and 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific
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monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff concentration because it will saturate all the binding sites of the antibody coated on the particles.
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 the tests have been performed properly.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
The BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use are identical physical devices but the BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use has different labeling appropriate for OTC users. Similarly, the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for OTC Use and the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for Rx Use are identical physical devices but the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for OTC Use has different labeling appropriate for OTC users. The precision testing is from one BIO-VENTURE Rapid Multi-Drug Test Easy Cup device and one BIO-VENTURE Rapid Multi-drug Test Split Key Cup 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. Results were as follows:
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use
| 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+ | 22-/28+ | 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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| 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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BIO-VENTURE Rapid Multi-Drug Test Rapid Split Key Cup for OTC Use and BIO-VENTURE Rapid Split Key Cup for Rx Use Use
| 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+ | 22-/28+ | 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 24-/26+ | 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 25-/25+ | 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- |
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| 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+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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- |
# 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 region. There are no external controls supplied with the device.
The sponsor claims that the devices are stable at $2 - 30^{\circ}\mathrm{C}$ for 24 months based on a real time stability study at room temperature.
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d. Detection limit:
Not applicable.
e. Analytical specificity:
Cross-reactivity
Cross-reactivity was evaluated by spiking in potential cross-reactants and titrating potential cross-reactants to find the lowest concentration of cross-reactant that produced a positive result with each device. The percent cross-reactivity was calculated as:
(cutoff concentration / lowest concentration causing a positive result) x 100
The results are summarized below for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use are representative of all formats.
AMP
| 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 |
| L-Methamphetamine | >100,000 | <1 |
COC
| 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 |
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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 |
| 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 |
| Cloraepate dipotassium | >100,000 | 0.3 |
| Desalkylflurazepam | >100,000 | 0.3 |
| Norchlordiazepoxide | >100,000 | 0.3 |
MET
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| p-Hydroxyamphetamine | 50000 | 2 |
| (+)3,4-Methylenedioxyamphetamine(MDA) | 20000 | 5 |
| (+)3,4-Methylenedioxymethamphetamine(MDMA) | 3000 | 33.3 |
| (+)3,4-methylenedioxy-n-ethylamphetamine(MDEA) | 5000 | 20 |
| D/L-Amphetamine | >100000 | <1 |
| D-Amphetamine | >100000 | <1 |
| D/L-Methamphetamine | 3000 | 33.3 |
| D-Methamphetamine | 1000 | 100 |
| L-Amphetamine | >100000 | 10 |
{11}
MOR
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Acetylmorphine | 6000 | 5 |
| Hydromorphone | 3000 | 10 |
| Hydrocodone | 50000 | .6 |
| Levorphanol | 1500 | 20 |
| Oxycodone | 50000 | .6 |
| Dimethylmorphine | 3000 | 10 |
| Morphine-3-Glucuronide | >100,000 | <0.3 |
| Morphine | 300 | 100 |
| Codeine | 300 | 100 |
| Heroin | 300 | 100 |
| O6-Monoacetylmorphine | 300 | 100 |
| Ethylmorphine | >100000 | <0.3 |
THC
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| (-)-11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 | 100 |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | 10000 | 0.5 |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | 2500 | 2 |
| Cannabinol | 5000 | 1 |
| 11-Nor-Δ9-THC-carboxy glucuronide | 5000 | 1 |
| (-)-11-nor-9-carboxy-Δ9-THC | 10000 | <0.5 |
| Δ8-Tetrahydrocannabinol | >50000 | <0.1 |
| Δ9-Tetrahydrocannabinol | >50000 | <0.1 |
| Cannabidiol | >50000 | <0.1 |
# Interferences
Interference was evaluated by spiking the potential interferents below into urine samples having test drug analytes at $\pm 25\%$ of the cutoff for each assay.
All potential interferents were tested at a concentration of $100~\mu \mathrm{g / mL}$ , except for Ethanol which was tested at a final concentration of $1\%$ . There were no deviations from the expected results for any of the devices.
{12}
AMP Assay
| 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 |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone acetate | Cholesterol | Hydrocortisone | Oxycodone |
| Ethanol | | | |
Oxazepam Assay
| 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 |
{13}
14
COC Assay
| 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 |
MET Assay
| 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 | |
{14}
MOP Assay
| 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 Assay
| 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 | | | |
Endogenous Interferents:
The effect of pH was evaluated by preparing samples with test drug analytes at ± 25% of the cutoff for all devices and adjusting the pH to 4.00 to 9.00, in increments of 1 pH unit. There were no deviations from the expected results.
The effect of specific gravity was evaluated by preparing samples with test drug analytes at ± 25% of the cutoff for all devices and adjusting the specific gravity from 1.002 - 1.033. There were no deviations from the expected results.
15
{15}
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 Multi-Drug Test Easy Cup for OTC Use and BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use Use are identical physical devices but the BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use has different labeling appropriate for OTC users. Similarly, the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for OTC Use and the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for Rx Use are identical physical devices but the BIO-VENTURE Rapid Multi-drug Test Split Key Cup for OTC Use has different labeling appropriate for OTC users. The method comparison testing is from one BIO-VENTURE Rapid Multi-Drug Test Easy Cup device and one BIO-VENTURE Rapid Multi-drug Test Split Key Cup but represents expected performance from both the Rx and OTC devices.
Unaltered, remnant clinical samples were obtained to test amphetamines, cocaine and oxazepam, morphine and THC. Three operators tested each sample, and each sample was also tested by GC-MS for comparison.
| Amphetamine – Easy Cup Format (87 samples total) | | Negative Urine | (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 | 16 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 27 |
| Operator 2 | Negative | 19 | 16 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 13 | 27 |
| Operator 3 | Negative | 19 | 16 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 14 | 27 |
Discordant results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 2 | 989 | Positive |
| 3 | 989 | Positive |
| 2 | 1035 | Negative |
| 1 | 1062 | Negative |
{16}
17
| Amphetamine – Split Key Cup Format (87 samples total) | | Negative Urine | (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 | 16 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 27 |
| Operator 2 | Negative | 19 | 16 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 13 | 27 |
| Operator 3 | Negative | 19 | 16 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 14 | 27 |
Discordant results
| Operator | GC/MS Result (ng/mL) | | Candidate Device Result | |
| --- | --- | --- | --- | --- |
| 2 | 989 | | Positive | |
| 3 | 989 | | Positive | |
| 2 | 1035 | | Negative | |
| 1 | 1062 | | Negative | |
| Oxazepam – Easy Cup Format (80 samples total) | | Negative Urine | (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 | 15 | 10 | 15 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 19 | 20 |
| Operator 2 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
| Operator 3 | Negative | 15 | 10 | 14 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 20 | 20 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 1 | 333 | Negative |
| 3 | 298 | Positive |
{17}
18
| Oxazepam –Split Key Cup Format (80 samples total) | | Negative Urine | (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 | 15 | 10 | 15 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 19 | 20 |
| Operator 2 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
| Operator 3 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 1 | 333 | Negative |
| COC – Easy Cup Format (80 samples total) | | Negative Urine | (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 | 18 | 13 | 11 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 15 | 21 |
| Operator 2 | Negative | 18 | 13 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 21 |
| Operator 3 | Negative | 18 | 13 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 17 | 21 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 3 | 285 | Positive |
| 1 | 313 | Negative |
| 2 | 313 | Negative |
| 1 | 321 | Negative |
{18}
19
| COC – Split Key Cup Format (80 samples total) | | Negative Urine | (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 | 18 | 13 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 21 |
| Operator 2 | Negative | 18 | 13 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 21 |
| Operator 3 | Negative | 18 | 13 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 17 | 21 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 3 | 285 | Positive |
| 1 | 313 | Negative |
| 2 | 313 | Negative |
| MET – Easy Cup Format (81 samples total) | | Negative Urine | (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 | 8 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 11 | 29 |
| Operator 2 | Negative | 17 | 16 | 8 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 10 | 29 |
| Operator 3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 2 | 1025 | Negative |
| 3 | 984 | Positive |
{19}
20
| MET – Split Key Cup Format (81 samples total) | | Negative Urine | (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 | 8 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 11 | 29 |
| Operator 2 | Negative | 17 | 16 | 8 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 10 | 29 |
| Operator 3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 2 | 1025 | Negative |
| 3 | 984 | Positive |
| MOR– Easy Cup Format (81 samples total) | | Negative Urine | (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 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 25 |
| Operator 3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 2 | 323 | Negative |
| 2 | 335 | Negative |
| 1 | 293 | Positive |
{20}
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 3 | 293 | Positive |
| MOR-Split Key Cup Format (81 samples total) | | Negative Urine | (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 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 14 | 25 |
| Operator 3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 2 | 323 | Negative |
| 1 | 293 | Positive |
| 3 | 293 | Positive |
| THC– Easy Cup Format (81 samples total) | | Negative Urine | (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 | 18 | 11 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 24 |
| Operator 2 | Negative | 18 | 11 | 13 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 14 | 24 |
| Operator 3 | Negative | 18 | 11 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 24 |
Discordant Results
{21}
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 1 | 61 | Negative |
| 2 | 61 | Negative |
| 1 | 61 | Negative |
| 1 | 59 | Negative |
| 2 | 59 | Negative |
| THC– Split Key Cup Format (82 samples total) | | Negative Urine | (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 | 18 | 11 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 24 |
| Operator 2 | Negative | 18 | 11 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 15 | 24 |
| Operator 3 | Negative | 18 | 11 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 24 |
# Discordant Results
| Operator | GC/MS Result (ng/mL) | Candidate Device Result |
| --- | --- | --- |
| 1 | 61 | Negative |
| 2 | 61 | Negative |
| 1 | 61 | Negative |
| 1 | 59 | Negative |
# b. Matrix comparison:
Not applicable.
# 3. Clinical studies:
# a. Clinical Sensitivity:
Not applicable.
# b. Clinical specificity:
Not applicable.
{22}
c. Other clinical supportive data (when a. and b. are not applicable):
# Lay user studies
A lay user study was performed by 140 lay persons for each format for the BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use and the BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use (280 lay persons total). The lay users had diverse educational and professional backgrounds and ranged in age from 20 to $>50$ years. Urine samples were prepared with test drug analytes 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. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (AMP)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 492 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 741 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1262 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1506 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 1744 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (Oxazepam)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 64 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 141 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 221 | 1 | 19 | 95 |
| +25% Cutoff | 40 | 362 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 440 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 530 | 20 | 0 | 100 |
{23}
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (COC)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 62 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 135 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 212 | 1 | 19 | 95 |
| +25% Cutoff | 40 | 365 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 444 | 0 | 0 | 100 |
| +75% Cutoff | 40 | 533 | 40 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (MET)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 489 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 734 | 0 | 20 | 100 |
| +25% Cutoff | 40 | 1284 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1535 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 1783 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (MOP)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 70 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 136 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 228 | 2 | 18 | 90 |
| +25% Cutoff | 40 | 378 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 445 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 510 | 20 | 0 | 100 |
{24}
BIO-VENTURE Rapid Multi-Drug Test Easy Cup (THC)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 10 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 24 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 36 | 0 | 20 | 100 |
| +25% Cutoff | 40 | 60 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 73 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 82 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (AMP)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 492 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 741 | 2 | 18 | 90 |
| +25% Cutoff | 40 | 1262 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 1506 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 1744 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (Oxazepam)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 64 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 141 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 221 | 0 | 20 | 100 |
| +25% Cutoff | 40 | 362 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 440 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 530 | 20 | 0 | 100 |
{25}
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (COC)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 62 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 135 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 212 | 1 | 19 | 95 |
| +25% Cutoff | 40 | 365 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 444 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 533 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (MET)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 489 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 734 | 0 | 20 | 100 |
| +25% Cutoff | 40 | 1284 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 1535 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 1783 | 20 | 0 | 100 |
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (MOP)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 70 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 136 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 228 | 1 | 19 | 95 |
| +25% Cutoff | 40 | 378 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 445 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 510 | 20 | 0 | 100 |
{26}
BIO-VENTURE Rapid Multi-Drug Test Split Key Cup (THC)
| % of Cutoff | Number of samples | Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| -100% Cutoff | 40 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 40 | 10 | 0 | 20 | 100 |
| -50% Cutoff | 40 | 24 | 0 | 20 | 100 |
| -25% Cutoff | 40 | 36 | 0 | 20 | 100 |
| +25% Cutoff | 40 | 60 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 73 | 20 | 0 | 100 |
| +75% Cutoff | 40 | 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.
