Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
Device Facts
| Record ID | K122809 |
|---|---|
| Device Name | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup |
| Applicant | Advin Biotech |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Jun 17, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels: [Table of 16 drugs/metabolites]. The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table. Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use. The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine. The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.
Device Story
Lateral flow immunochromatographic competitive binding assay; detects drugs/metabolites in human urine. Input: urine specimen; principle: competitive binding antigen-antibody immunochemistry using anti-drug antibodies. Output: visual colored lines in test/control regions; no instrument required. Used in point-of-care, lab, workplace, and home settings by professionals or lay users. Positive result: absence of colored line in test region; negative result: presence of colored line. Procedural control line confirms proper wicking. Optional adulteration strips detect oxidant, specific gravity, pH, glutaraldehyde, creatinine, and nitrite. Provides preliminary results; requires GC/MS, LC/MS/MS, or HPLC confirmation. Assists clinical decision-making by identifying potential drug presence.
Clinical Evidence
No clinical diagnostic data. Bench testing included precision/reproducibility studies at three POC sites, cross-reactivity/interference testing, and method comparison against GC/MS/LC-MS. A consumer study (n=100) evaluated lay user performance across all formats, confirming ease of use and readability.
Technological Characteristics
Lateral flow immunochromatographic competitive binding assay. Formats: Cassette, Dipcard, Cup. Visual readout; no energy source. Includes optional adulteration reagent pads (oxidant, specific gravity, pH, glutaraldehyde, creatinine, nitrite).
Indications for Use
Indicated for qualitative detection of drugs of abuse and metabolites in human urine. Target population: individuals requiring drug screening in point-of-care, laboratory, workplace, or OTC settings. Analytes: AMP, BAR, BZO, BUP, COC, EDDP, MDMA, MET, MTD, MOR, OPI, OXY, PCP, PPX, TCA, THC. Propoxyphene (PPX) excluded from OTC use.
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
- Innovacon Spectrum II Test Card and Test Card with Integrated Test Cup (k061718)
Related Devices
- K130665 — WONDOFO MULTI-DRUG URINE TEST CUP / PANEL · Guangzhou Wondfo Biotech Co., Ltd. · Apr 9, 2013
- K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · May 23, 2016
- K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) · Hangzhou AllTest Biotech Co., Ltd. · Mar 27, 2019
- K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel · Hangzhou AllTest Biotech Co., Ltd. · Sep 27, 2024
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k122809
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Methamphetamine, Barbiturates, Benzodiazepine, Opiate, Cannabinoids, Cocaine, Methadone, Tricyclic antidepressants, Buprenorphine, EDDP, MDMA, Morphine, Oxycodone, Phencyclidine and Propoxyphene
D. Type of Test:
Qualitative lateral flow immunochromatographic competitive binding assay
E. Applicant:
Advin Biotech
F. Proprietary and Established Names:
Advin Multi-Drug Screen Test Cassette
Advin Multi-Drug Screen Test Dip Card
Advin Multi-Drug Screen Test Cup
G. Regulatory Information:
1. Regulation section:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | II | 862.3100, Amphetamine test system | Toxicology - 91 |
| DJC | II | 862.3610, Methamphetamine test system | Toxicology - 91 |
| DIS | II | 862.3150, Barbiturate test system | Toxicology - 91 |
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# H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
| Drug Test | Calibrator | Cutoff Level |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 500 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 150 ng/mL |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL |
| Ecstasy (MDMA) | Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | d-Methamphetamine | 500 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Morphine (MOR300) | Morphine | 300 ng/mL |
| Opiates (OPI) | Morphine | 2000 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | Propoxyphene | 300 ng/mL |
| Tricyclic-antidepressant (TCA) | Nortriptyline | 1000 ng/mL |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
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The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table.
Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings, and is also intended for workplaces and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.
The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine.
The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.
3. Special conditions for use statement(s):
This assay is intended for prescription use and over the counter use
4. Special instrument requirements:
Not applicable; this is a visually read single use device
I. Device Description:
The Advin Multi-Drug Screen Test consists of multi-drug test strips with one or two drug tests on each strip. Each of the two-drug test strips detects two drugs. Each two-drug test strip can also be formulated into two 1-drug test strip, where each test strip only detects one drug. The Advin Multi-Drug Screen Test has three types of test formats: a Cassette, a Dip Card and a Cup. All three formats use identical test strips made with same chemical formulation and manufacturing procedures.
The differences between the test formats are that (1) the Cassette format has a plastic cassette to hold the test strip; urine sample can be applied onto the sample well; (2) the Dip Card has a plastic card to hold the strips for dipping and a cap to expose the sample pads; and (3) the Cup format has an integrated cup with lid to hold the strips.
J. Substantial Equivalence Information:
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1. Predicate device name(s):
Innovacon Spectrum II Test Card and Test Card with Integrated Test Cup
2. Predicate 510(k) number(s):
k061718
3. Comparison with predicate:
| Similarities/Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | A rapid chromatographic immunoassay for the qualitative detection of multiple drugs/metabolites in human urine | Same |
| Sample Type | Urine | Same |
| Materials provided | Test devices (Cassette, Dipcard, Cup) and Package insert | Test Device (Test card, Cup) and Package insert |
| Cutoff concentrations (ng/mL) | Amphetamine 500
Barbiturates 300
Benzodiazepines 300
Buprenorphine 10
Cocaine 150
Methadone 300
MDMA 500
THC 50
Methamphetamine 500
morphine 300, or opiates 2,000
Oxycodone 100
Phencyclidine 25
Propoxyphene 300
Tricyclic antidepressants 1,000,
EDDP 300 | Amphetamine 1000 or 300
Barbiturates 300
Benzodiazepines 300
Buprenorphine 10
Cocaine 150 or 300
Methadone 300
MDMA 500
THC 50
Methamphetamine 500 or 1,000
morphine 300, or opiates 2,000
Oxycodone 100
Phencyclidine 25
Propoxyphene 300
Tricyclic antidepressants 1,000
EDDP 300 |
| Methodology | Membrane Particle Assay | Same |
| Test time | 5 minutes | Same |
| Format | Immunoassay | Same |
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K. Standard/Guidance Document Referenced (if applicable):
- EN ISO13485, Medical devices – quality management systems – Requirements for regulatory purpose
- EN ISO14971, Medical device – application of risk management to medical device
- EN ISO14155-2, Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans
L. Test Principle:
The Advin Multi-Drug Screen Test is a lateral flow immunochromatographic competitive binding assay and is intended for prescription, workplace and OTC use. It is used as *in vitro* diagnostic to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens. The test is based on the principle of competitive binding antigen-antibody immunochemistry. Urine migrates via capillary action along the nitrocellulose (NC) membrane strip pre-coated with a drug-protein conjugate band on the test line region and a colored antibody-colloidal gold conjugate pad, and rehydrates the antibody colloidal gold conjugate on test strip. This urine-gold conjugate mixture then migrates along the NC membrane to the immobilized drug-protein band. When a drug is absent in the urine, the colored antibody-colloidal gold conjugate and immobilized drug-protein bind specifically to form a visible color line on the test region. A drug-positive urine specimen will not generate a colored-line in the designated test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of urine specimen has been added and membrane wicking has occurred. These visual read tests are performed without the use of an instrument.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision of the device was characterized at three Physician’s Lab Office (POL) sites using office personnel of varying educational backgrounds and laboratory experience. Several samples were prepared for this study using drug-free urine specimens collected and pooled from volunteers. Drug standards were spiked into the drug-free urine to the following drug concentrations: 0% cutoff, -50% cutoff, -25% cutoff, at cutoff, +25% cutoff and +50% cutoff. Each concentration was confirmed with GC/MS. Each sample was analyzed in 10 replicates by each of the testing personnel at each POL site, using each of the three assay formats. Results are presented below for each test format.
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Cassette
| | | Drug concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | Cutoff | +25% | +50% |
| AMP 500 ng/ml | Neg | 60 | 60 | 42 | 13 | 8 | 0 |
| | Pos | 0 | 0 | 18 | 47 | 52 | 60 |
| | Total | 60 | 60 | 60 | 60 | 60 | 60 |
| MOR 300 ng/ml | Neg | 30 | 30 | 22 | 8 | 8 | 0 |
| | Pos | 0 | 0 | 8 | 22 | 22 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| COC 150 ng/ml | Neg | 30 | 30 | 22 | 6 | 4 | 0 |
| | Pos | 0 | 0 | 8 | 24 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| THC 50 ng/mL | Neg | 30 | 30 | 22 | 5 | 3 | 0 |
| | Pos | 0 | 0 | 8 | 25 | 27 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| MET 500 ng/mL | Neg | 30 | 30 | 21 | 8 | 6 | 0 |
| | Pos | 0 | 0 | 9 | 22 | 24 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| PCP 25 ng/mL | Neg | 30 | 30 | 23 | 6 | 5 | 0 |
| | Pos | 0 | 0 | 7 | 24 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| Barb 300 ng/mL | Neg | 30 | 30 | 21 | 6 | 5 | 0 |
| | Pos | 0 | 0 | 9 | 24 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| BZO 300 ng/mL | Neg | 30 | 30 | 23 | 8 | 4 | 0 |
| | Pos | 0 | 0 | 7 | 22 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| PPX 300 ng/mL | Neg | 30 | 30 | 22 | 4 | 5 | 0 |
| | Pos | 0 | 0 | 8 | 26 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| BUP 10 ng/mL | Neg | 30 | 30 | 24 | 5 | 5 | 0 |
| | Pos | 0 | 0 | 6 | 25 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| EDDP 300 ng/mL | Neg | 30 | 30 | 22 | 8 | 9 | 0 |
| | Pos | 0 | 0 | 8 | 22 | 21 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| MTD 300 ng/mL | Neg | 30 | 30 | 21 | 7 | 6 | 0 |
| | Pos | 0 | 0 | 9 | 23 | 24 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| TCA 1000 ng/mL | Neg | 30 | 30 | 22 | 5 | 4 | 0 |
| | Pos | 0 | 0 | 8 | 25 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| OPI 2000 ng/mL | Neg | 30 | 30 | 25 | 7 | 7 | 0 |
| | Pos | 0 | 0 | 5 | 23 | 23 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
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| MDMA
500 ng/mL | Neg | 30 | 30 | 22 | 5 | 7 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Pos | 0 | 0 | 8 | 25 | 23 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| OXY
100 ng/ml | Neg | 30 | 30 | 21 | 7 | 4 | 0 |
| | Pos | 0 | 0 | 9 | 23 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
Dip card
| | | Drug concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | Cutoff | +25% | +50% |
| AMP
500 ng/ml | Neg | 60 | 60 | 45 | 14 | 11 | 0 |
| | Pos | 0 | 0 | 15 | 46 | 49 | 60 |
| | Total | 60 | 60 | 60 | 60 | 60 | 60 |
| MOR
300 ng/ml | Neg | 30 | 30 | 23 | 8 | 8 | 0 |
| | Pos | 0 | 0 | 7 | 22 | 22 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| COC
150 ng/ml | Neg | 30 | 30 | 21 | 8 | 5 | 0 |
| | Pos | 0 | 0 | 9 | 22 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| THC
50 ng/mL | Neg | 30 | 30 | 23 | 5 | 4 | 0 |
| | Pos | 0 | 0 | 7 | 25 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| MET
500 ng/mL | Neg | 30 | 30 | 22 | 8 | 4 | 0 |
| | Pos | 0 | 0 | 8 | 22 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| PCP
25 ng/mL | Neg | 30 | 30 | 24 | 6 | 6 | 0 |
| | Pos | 0 | 0 | 6 | 24 | 24 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| Barb
300 ng/mL | Neg | 30 | 30 | 23 | 6 | 5 | 0 |
| | Pos | 0 | 0 | 7 | 24 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| BZO
300 ng/mL | Neg | 30 | 30 | 23 | 7 | 4 | 0 |
| | Pos | 0 | 0 | 7 | 23 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| PPX
300 ng/mL | Neg | 30 | 30 | 22 | 4 | 7 | 0 |
| | Pos | 0 | 0 | 8 | 26 | 23 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| BUP
10 ng/mL | Neg | 30 | 30 | 23 | 5 | 6 | 0 |
| | Pos | 0 | 0 | 7 | 25 | 24 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| EDDP
300 ng/mL | Neg | 30 | 30 | 23 | 9 | 8 | 0 |
| | Pos | 0 | 0 | 4 | 21 | 22 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
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| MTD 300 ng/mL | Neg | 30 | 30 | 21 | 8 | 5 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Pos | 0 | 0 | 9 | 22 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| TCA 1000 ng/mL | Neg | 30 | 30 | 21 | 5 | 4 | 0 |
| | Pos | 0 | 0 | 9 | 25 | 26 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| OPI 2000 ng/mL | Neg | 30 | 30 | 23 | 7 | 5 | 0 |
| | Pos | 0 | 0 | 7 | 23 | 25 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| MDMA 500 ng/mL | Neg | 30 | 30 | 25 | 6 | 8 | 0 |
| | Pos | 0 | 0 | 5 | 24 | 22 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| OXY 100 ng/ml | Neg | 30 | 30 | 22 | 8 | 3 | 0 |
| | Pos | 0 | 0 | 8 | 22 | 27 | 30 |
| | Total | 30 | 30 | 30 | 30 | 30 | 30 |
Cup
| | | Drug concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | Cutoff | +25% | +50% |
| AMP 500 ng/ml | Neg | 120 | 120 | 82 | 33 | 25 | 0 |
| | Pos | 0 | 0 | 38 | 87 | 95 | 120 |
| | Total | 120 | 120 | 120 | 120 | 120 | 60 |
| MOR 300 ng/ml | Neg | 60 | 30 | 24 | 9 | 8 | 0 |
| | Pos | 0 | 0 | 6 | 21 | 22 | 30 |
| | Total | 60 | 30 | 30 | 30 | 30 | 30 |
| COC 150 ng/ml | Neg | 210 | 30 | 21 | 9 | 6 | 0 |
| | Pos | 0 | 0 | 9 | 21 | 24 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| THC 50 ng/mL | Neg | 210 | 30 | 24 | 4 | 4 | 0 |
| | Pos | 0 | 0 | 6 | 26 | 26 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| MET 500 ng/mL | Neg | 210 | 30 | 21 | 9 | 6 | 0 |
| | Pos | 0 | 0 | 9 | 21 | 24 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| PCP 25 ng/mL | Neg | 210 | 30 | 26 | 6 | 6 | 0 |
| | Pos | 0 | 0 | 4 | 24 | 24 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| Barb 300 ng/mL | Neg | 210 | 30 | 21 | 6 | 8 | 0 |
| | Pos | 0 | 0 | 9 | 24 | 22 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| BZO 300 ng/mL | Neg | 210 | 30 | 26 | 8 | 4 | 0 |
| | Pos | 0 | 0 | 4 | 22 | 26 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| PPX | Neg | 210 | 30 | 20 | 4 | 6 | 0 |
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| 300 ng/mL | Pos | 0 | 0 | 10 | 26 | 24 | 30 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| BUP
10 ng/mL | Neg | 210 | 30 | 22 | 4 | 6 | 0 |
| | Pos | 0 | 0 | 8 | 26 | 24 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| EDDP
300 ng/mL | Neg | 210 | 30 | 24 | 9 | 9 | 0 |
| | Pos | 0 | 0 | 6 | 21 | 21 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| MTD
300 ng/mL | Neg | 210 | 30 | 21 | 9 | 6 | 0 |
| | Pos | 0 | 0 | 9 | 21 | 24 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| TCA
1000 ng/mL | Neg | 210 | 30 | 26 | 6 | 4 | 0 |
| | Pos | 0 | 0 | 6 | 24 | 26 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| OPI
2000 ng/mL | Neg | 60 | 30 | 26 | 7 | 7 | 0 |
| | Pos | 0 | 0 | 4 | 23 | 23 | 30 |
| | Total | 60 | 30 | 30 | 30 | 30 | 30 |
| MDMA
500 ng/mL | Neg | 210 | 30 | 22 | 6 | 9 | 0 |
| | Pos | 0 | 0 | 8 | 24 | 21 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
| OXY
100 ng/ml | Neg | 210 | 30 | 24 | 9 | 4 | 0 |
| | Pos | 0 | 0 | 6 | 21 | 26 | 30 |
| | Total | 210 | 30 | 30 | 30 | 30 | 30 |
b. Linearity/assay reportable range:
Not applicable. The assays are intended for qualitative use.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control standards are not supplied with this device; however, this device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region.
Stability
Accelerated and real time studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date: The Advin Multi-Drug Screen Test unopened (shelf-life) stability is 24 months for all formats (cassette, cup and dip card).
d. Detection limit:
Not applicable. The assay is intended for qualitative use.
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# e. Analytical specificity:
# Cross Reactivity Study:
Each compound was tested for cross reactivity with certain compounds, drugs, and drug metabolites. Each compound was spiked to drug-free urine to $100\mu \mathrm{g / mL}$ . Each sample was tested in 3 replicates. If any positive result was observed, the compound, drug/drug metabolites were further diluted sequentially to different concentrations and tested in triplicates until the highest concentration that generates negative result. The cross reacting substances with the lowest concentration that produces a positive result was identified and are presented in the product package insert. Results are shown below.
Amphetamine
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| d-Amphetamine | 500 | 100% |
| L-amphetamine | 50,000 | 1% |
| MDA | 8,000 | 6.5% |
| Phentermine | 45,000 | 1.1% |
Cocaine
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Benzoylecgonine | 150 | 100% |
| Cocaine | 5,000 | 3% |
| Cocaethylene | 50,000 | 0.3% |
| Ecgonine | 50,000 | 0.3% |
Methamphetamine
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| d-Methamphetamine | 500 | 100% |
| Ephedrine | 100,000 | 0.5% |
| MDEA | 30,000 | 1.7% |
| MDMA | 3,500 | 14.3% |
| Mephentermine | 75,000 | 0.7% |
| d-Amphetamine | 50,000 | 1% |
| L-Amphetamine | 50,000 | 1% |
Morphine
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 100 | 300% |
| Ethylmorphine | 100 | 300% |
| Heroine | 800 | 37.5% |
| Hydrocodone | 1,250 | 24% |
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| Hydromorphone | 2,500 | 12% |
| --- | --- | --- |
| Levophenol | 50,000 | 0.6% |
| Morphine3-glucuronide | 400 | 75% |
| Norcodeine | 16,000 | 1.9% |
| Oxycodone | 75,000 | 0.4% |
| Thebaine | 90,000 | 0.3% |
Opiate
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 2,000 | 100% |
| Oxycodone | 70,000 | 2.9% |
| Codeine | 1,800 | 111.1% |
| Morphine3-glucuronide | 2,600 | 76.9% |
| Ethylmorphine | 1,500 | 133.3% |
| Hydrocodone | 5,000 | 40% |
| Hydromorphone | 5,000 | 40%% |
| Thebaine | 95,000 | 2.1% |
| Heroine | 11,000 | 18.2% |
PCP
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-hydroxy-PCP | 1,500 | 1.7% |
THC
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| (+/-)11-hydroxy-Δ9-THC | 5,000 | 1% |
| (-)-Δ8-THC | 20,000 | 0.3% |
| (-)-Δ9-THC | 20,000 | 0.3% |
MDMA
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| (+/-)-MDMA | 500 | 100% |
| (+/-)-MDA | 3,900 | 12.8% |
| (+/-)-MDEA | 500 | 100% |
Buprenorphine
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Buprenorphine | 10 | 100% |
{11}
12
Oxycodone
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Hydromorphone | 25,000 | 0.4% |
| Hydrocodone | 5,000 | 2% |
| Oxymorphone | 12,500 | 0.8% |
| Ethymorphine | 50,000 | 0.2% |
| Codeine | 50,000 | 0.2% |
Benzodiazepines
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alpha-hydroxyalprazolam | 1,900 | 15.8% |
| Alprazolam | 200 | 150% |
| Bromazepam | 1,000 | 30% |
| Clobazam | 200 | 150% |
| Clorazepam | 750 | 40% |
| Desalkyflurazepam | 1,200 | 25% |
| Diazepam | 1,000 | 30% |
| Flunitrazepam | 250 | 120% |
| Lorazepam | 3,900 | 7.7% |
| Lorazepam-glucuronide | 5,000 | 6% |
| Nitrazepam | 250 | 120% |
| Nordiazepam | 390 | 76.9% |
| Norchlordiazepapoxide | 500 | 60% |
| Nordiazepoxide | 400 | 75% |
| Temazepam | 150 | 200% |
| Triazolam | 2,500 | 12% |
Barbiturates
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Amorbarbital | 2,500 | 12% |
| Aprobarbital | 500 | 60% |
| Butabarbital | 100 | 300% |
| Butalbital | 300 | 100% |
| Cyclopentobarbital | 500 | 60% |
| Phenobarbital | 300 | 100% |
| Phentobarbital | 250 | 120% |
Methadone
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
{12}
EDDP
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| EDDP | 300 | 100% |
TCA
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Nortriptyline | 1,000 | 100% |
| Amitriptyline | 4,000 | 25% |
| Clomipramine | 2,000 | 50% |
| Doxepine | 1,000 | 100% |
| Desipramine | 500 | 200% |
| Imipramine | 1,000 | 100% |
| Promethazine | 1,000 | 100% |
| Trimipramine | 5,000 | 20% |
PPX
| Compound | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Propoxyphene | 300 | 100% |
| Nor-propoxyphene | 300 | 100% |
# Interference Study:
The following unrelated compounds were found not to cross-react when tested spiked $(100\mu \mathrm{g} / \mathrm{mL})$ into drug-free urine, as well as into urine spiked with $\pm 25\%$ of the cutoff concentration for each individual drug:
| Acetaminophen | Erythromycin | Penicillin-G |
| --- | --- | --- |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Glucose | L-Phenylephrine |
| Ampicillin | Guaiacol glyceryl ether | B-Phenylethylamin |
| Ascorbic Acid | Hemoglobin | Phencyclidine |
| Aspartame | Ibuprofen | Procaine |
| Aspirin | Ketamine | Propoxyphene |
| Atropine | Levorphanol | Quinidine |
| Benzocaine | Lidocaine | Ranitidine |
| Benzoic acid | Lysergic acid | Riboflavin |
| Benzoylecgonine | Methadone | Salicylic acid |
| Bilirubin | Methanol | Secobarbital |
| Caffeine | Methaqualone | Sodium Chloride |
| Chlorquine | Morphine | Sulindac |
| (±) Chlolrpheniramine | (1R,2S)-(-)-n-Methyl-ephedrine | Theophyline |
| Creatine | (+)-Naproxen | Tyramine |
{13}
| Dexbrompheniramine | Niacinamide | Uric acid |
| --- | --- | --- |
| Dextromethorphan | Nicotine | Vitamin (L-Ascorbic Acid) |
| Dophenhydramine | (+/-)-Norephedrine | 4-Dimethylaminoantipyrine |
| Dopamine | Nortriptyline | d-Amphetamine |
| (+/-)-Isoproterenol | Nordiazepam | |
| 1R,2S(+)-Ephedrine | Oxalic acid | |
Evaluation of Specific Gravity and pH on test results:
To evaluate the effect of pH value on the test results, negative urine samples were adjusted to pH levels 3.0, 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0. The samples were then spiked with drug at +/-25% of the cutoff values. Testing was performed on 3 lots/device (dip card, cassette and cup).
To evaluate the effect of specific gravity, samples specific gravities of 1.010, 1.020, and 1.030, were spiked with drug at +/-25% of the cut-off values. Testing was performed on 3 lots/device (dip card, cassette and cup).
The testing results demonstrate that varying pH's and specific gravities do not affect urine testing results around each analyte cut-off.
f. Assay cut-off:
The cut-off characterization study results can be found in the precision section of this summary.
2. Comparison studies:
a. Method comparison with predicate device:
In order to characterize performance of the Advin Multi-Drug Screen Tests compared with Mass Spectrometry testing, forty drug-free urine samples were collected from presumed non-user volunteers and at least 40 drug positive unaltered urine specimens for each drug test were obtained from several reference labs. Each specimen was tested with Advin Multi-Drug Screen Test Cassette, Dip card and Cup by 3 operators at 1 POC site. Results are presented below.
{14}
| Drug | Candidate Cassette Device Results | Negative | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| AMP | Positive | 0 | 1 | 4 | 45 |
| | Negative | 40 | 3 | 0 | 0 |
| Barb | Positive | 0 | 2 | 7 | 36 |
| | Negative | 40 | 2 | 0 | 0 |
| Bup | Positive | 0 | 2 | 8 | 32 |
| | Negative | 40 | 2 | 0 | 0 |
| BZO | Positive | 0 | 3 | 7 | 34 |
| | Negative | 40 | 1 | 0 | 0 |
| COC | Positive | 0 | 1 | 5 | 53 |
| | Negative | 40 | 3 | 0 | 0 |
| EDDP | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| MDMA | Positive | 0 | 2 | 6 | 34 |
| | Negative | 40 | 2 | 0 | 0 |
| METH | Positive | 0 | 3 | 4 | 51 |
| | Negative | 40 | 1 | 0 | 0 |
| MOR | Positive | 0 | 3 | 4 | 53 |
| | Negative | 40 | 1 | 0 | 0 |
| MTD | Positive | 0 | 2 | 4 | 37 |
| | Negative | 40 | 2 | 0 | 0 |
| OPI | Positive | 0 | 2 | 7 | 40 |
| | Negative | 40 | 1 | 0 | 0 |
| OXY | Positive | 0 | 3 | 8 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| PCP | Positive | 0 | 1 | 11 | 33 |
| | Negative | 40 | 3 | 0 | 0 |
| PPX | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| TCA | Positive | 0 | 2 | 12 | 28 |
| | Negative | 40 | 2 | 0 | 0 |
| THC | Positive | 0 | 1 | 11 | 44 |
| | Negative | 40 | 3 | 0 | 0 |
{15}
Analysis of Discordant Results with Admin Multi-Drug Screen Test Cassette
| Drug Test/Cutoff (ng/mL) | Advin Multi-Drug Screen Test Cassette Discordant Test Result (Positive or Negative by Visual Read) | GC/MS or LCMS Analysis | |
| --- | --- | --- | --- |
| | | Drug Concentration (ng/mL) | Drug in Urine |
| AMP/500 | Positive | 477 | Amphetamine |
| BZO/300 | Positive | 244 | Oxazepam |
| BZO/300 | Positive | 252 | Oxazepam |
| BZO/300 | Positive | 295 | Oxazepam |
| COC/150 | Positive | 146 | Benzoylecgonine |
| EDDP/300 | Positive | 250 | EDDP |
| EDDP/300 | Positive | 263 | EDDP |
| EDDP/300 | Positive | 275 | EDDP |
| BAR/300 | Positive | 265 | Barbital |
| BAR/300 | Positive | 286 | Barbital |
| BUP/10 | Positive | 8 | Buprenorphine |
| BUP/10 | Positive | 9 | Buprenorphine |
| OXY/100 | Positive | 88 | Oxycodone |
| OXY/100 | Positive | 98 | Oxycodone |
| OXY/100 | Positive | 99 | Oxycodone |
| OPI/2,000 | Positive | 1,898 | Morphine |
| OPI/2,000 | Positive | 1,990 | Morphine |
| MOR/300 | Positive | 260 | Morphine |
| MOR/300 | Positive | 263 | Morphine |
| MOR/300 | Positive | 292 | Morphine |
| MET/500 | Positive | 394 | Methamphetamine |
| MET/500 | Positive | 461 | Methamphetamine |
| MET/500 | Positive | 1809 | Methamphetamine Amphetamine |
| MTD/300 | Positive | 266 | Methadone |
| MTD/300 | Positive | 273 | Methadone |
| PPX/300 | Positive | 242 | Norpropoxyphene |
| PPX/300 | Positive | 285 | Norpropoxyphene |
| PCP/25 | Positive | 22.9 | Phencyclidine |
| THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH |
| TCA/1,000 | Positive | 786 | Nortriptyline |
| TCA/1,000 | Positive | 859 | Nortriptyline |
| MDMA/500 | Positive | 368 | MDMA |
| MDMA/500 | Positive | 439 | MDMA MDA |
{16}
| Drug | Candidate Dipcard Device Results | Negative | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| AMP | Positive | 0 | 1 | 4 | 45 |
| | Negative | 40 | 3 | 0 | 0 |
| Barb | Positive | 0 | 2 | 7 | 36 |
| | Negative | 40 | 2 | 0 | 0 |
| Bup | Positive | 0 | 2 | 8 | 32 |
| | Negative | 40 | 2 | 0 | 0 |
| BZO | Positive | 0 | 3 | 7 | 34 |
| | Negative | 40 | 1 | 0 | 0 |
| COC | Positive | 0 | 1 | 4 | 36 |
| | Negative | 40 | 3 | 0 | 0 |
| EDDP | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| MDMA | Positive | 0 | 2 | 6 | 34 |
| | Negative | 40 | 2 | 0 | 0 |
| METH | Positive | 0 | 3 | 4 | 51 |
| | Negative | 40 | 1 | 0 | 0 |
| MOR | Positive | 0 | 3 | 4 | 53 |
| | Negative | 40 | 1 | 0 | 0 |
| MTD | Positive | 0 | 2 | 4 | 37 |
| | Negative | 40 | 2 | 0 | 0 |
| OPI | Positive | 0 | 2 | 7 | 40 |
| | Negative | 40 | 1 | 0 | 0 |
| OXY | Positive | 0 | 3 | 8 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| PCP | Positive | 0 | 1 | 11 | 33 |
| | Negative | 40 | 3 | 0 | 0 |
| PPX | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| TCA | Positive | 0 | 2 | 12 | 28 |
| | Negative | 40 | 2 | 0 | 0 |
| THC | Positive | 0 | 1 | 11 | 44 |
| | Negative | 40 | 3 | 0 | 0 |
{17}
Analysis of Discordant Result with Admin Multi-Drug Screen Test Dipcard
| Assay Cutoff value | Device Pos/Neg | Major metabolite by GC/MS or LC/MS |
| --- | --- | --- |
| AMP500 | Positive | 477 Amphetamine |
| BZO300 | Positive | 244 Oxaxepam |
| BZO300 | Positive | 252 Oxaxepam |
| BZO300 | Positive | 295 Oxaxepam |
| COC150 | Positive | 146 Benzoylecgonine |
| EDDP300 | Positive | 250 EDDP |
| EDDP300 | Positive | 263 EDDP |
| EDDP300 | Positive | 275 EDDP |
| BAR300 | Positive | 265 Barbital |
| BAR300 | Positive | 286 Barbital |
| BUP10 | Positive | 8 Buprenorphine |
| BUP10 | Positive | 9 Buprenorphine |
| OXY100 | Positive | 88 Oxycodone |
| OXY100 | Positive | 98 Oxycodone |
| OXY100 | Positive | 99 Oxycodone |
| OPI2,000 | Positive | 1,898 Morphine |
| OPI2,000 | Positive | 1,990 Morphine |
| MOR300 | Positive | 260 Morphine |
| MOR300 | Positive | 263 Morphine |
| MOR300 | Positive | 292 Morphine |
| MET500 | Positive | 394 Methamphetamine |
| MET500 | Positive | 461 Methamphetamine |
| MET500 | Positive | 1809 Methamphetamine, Amphetamine |
| MTD300 | Positive | 266 Methadone |
| MTD300 | Positive | 273 Methadone |
| PPX300 | Positive | 242 Norpropoxyphene |
| PPX300 | Positive | 285 Norpropoxyphene |
| PCP25 | Positive | 22.9 Phencyclidine |
| THC50 | Positive | 49 11-nor-Δ9-THC-9-COOH |
| TCA1,000 | Positive | 786 Nortriptyline |
| TCA1,000 | Positive | 859 Nortriptyline |
| MDMA500 | Positive | 368 MDMA |
| MDMA500 | Positive | 439 MDMA, MDA |
{18}
| Drug | Candidate CupDevice Results | Negative | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| AMP | Positive | 0 | 1 | 4 | 45 |
| | Negative | 40 | 3 | 0 | 0 |
| Barb | Positive | 0 | 2 | 7 | 36 |
| | Negative | 40 | 2 | 0 | 0 |
| Bup | Positive | 0 | 2 | 8 | 32 |
| | Negative | 40 | 2 | 0 | 0 |
| BZO | Positive | 0 | 3 | 7 | 34 |
| | Negative | 40 | 1 | 0 | 0 |
| COC | Positive | 0 | 1 | 5 | 53 |
| | Negative | 40 | 3 | 0 | 0 |
| EDDP | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| MDMA | Positive | 0 | 2 | 6 | 34 |
| | Negative | 40 | 2 | 0 | 0 |
| METH | Positive | 0 | 3 | 4 | 51 |
| | Negative | 40 | 1 | 0 | 0 |
| MOR | Positive | 0 | 3 | 4 | 53 |
| | Negative | 40 | 1 | 0 | 0 |
| MTD | Positive | 0 | 2 | 4 | 37 |
| | Negative | 40 | 2 | 0 | 0 |
| OPI | Positive | 0 | 2 | 7 | 40 |
| | Negative | 40 | 1 | 0 | 0 |
| OXY | Positive | 0 | 3 | 8 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| PCP | Positive | 0 | 1 | 11 | 33 |
| | Negative | 40 | 3 | 0 | 0 |
| PPX | Positive | 0 | 3 | 7 | 33 |
| | Negative | 40 | 1 | 0 | 0 |
| TCA | Positive | 0 | 2 | 12 | 28 |
| | Negative | 40 | 2 | 0 | 0 |
| THC | Positive | 0 | 1 | 11 | 44 |
| | Negative | 40 | 3 | 0 | 0 |
{19}
Analysis of Discordant Results with Admin Multi-Drug Screen Test Cup
| Drug Test/Cutoff (ng/mL) | Advin Multi-Drug Screen Test Cassette Discordant Test Result (Positive or Negative by Visual Read) | GC/MS or LCMS Analysis | |
| --- | --- | --- | --- |
| | | Drug Concentration (ng/mL) | Drug in Urine |
| AMP/500 | Positive | 477 | Amphetamine |
| BZO/300 | Positive | 244 | Oxazepam |
| BZO/300 | Positive | 252 | Oxazepam |
| BZO/300 | Positive | 295 | Oxazepam |
| COC/150 | Positive | 146 | Benzoylecgonine |
| EDDP/300 | Positive | 250 | EDDP |
| EDDP/300 | Positive | 263 | EDDP |
| EDDP/300 | Positive | 275 | EDDP |
| BAR/300 | Positive | 265 | Barbital |
| BAR/300 | Positive | 286 | Barbital |
| BUP/10 | Positive | 8 | Buprenorphine |
| BUP/10 | Positive | 9 | Buprenorphine |
| OXY/100 | Positive | 88 | Oxycodone |
| OXY/100 | Positive | 98 | Oxycodone |
| OXY/100 | Positive | 99 | Oxycodone |
| OPI/2,000 | Positive | 1,898 | Morphine |
| OPI/2,000 | Positive | 1,990 | Morphine |
| MOR/300 | Positive | 260 | Morphine |
| MOR/300 | Positive | 263 | Morphine |
| MOR/300 | Positive | 292 | Morphine |
| MET/500 | Positive | 394 | Methamphetamine |
| MET/500 | Positive | 461 | Methamphetamine |
| MET/500 | Positive | 1809 | Methamphetamine Amphetamine |
| MTD/300 | Positive | 266 | Methadone |
| MTD/300 | Positive | 273 | Methadone |
| PPX/300 | Positive | 242 | Norpropoxyphene |
| PPX/300 | Positive | 285 | Norpropoxyphene |
| PCP/25 | Positive | 22.9 | Phencyclidine |
| THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH |
| TCA/1,000 | Positive | 786 | Nortriptyline |
| TCA/1,000 | Positive | 859 | Nortriptyline |
| MDMA/500 | Positive | 368 | MDMA |
| MDMA/500 | Positive | 439 | MDMA MDA |
{20}
b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.
# 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):
# Consumer Study:
Drug-free urine samples were spiked with following different drugs to different concentrations: $+ / 50\%$ cutoff, $+ / - 25\%$ cutoff and $0\%$ cutoff. Each solution was labeled with different code numbers.
One hundred male and female persons age 18 or older participated in the lay person user study for the Advin Multi -Drug Screen Test. Each participant performed 2-5 tests on provided specimens with each of the three formats of Advin Multi-Drug Screen Test (Cassette, Dip Card and Cup) by following the instructions in the product package inserts. The test solutions were blinded and randomized for different test formats. Each level of the drug solutions was randomly tested with 20- 24 replicates. Over 100 test results for a total of 6 drug concentration levels were obtained from the lay users study. Study participants recorded the test results on provided data sheets. Results are shown below.
Cassette
| | | Drug Concentration | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | +25% | +50% |
| AMP 500 ng/mL | Negative | 44 | 44 | 36 | 7 | 0 |
| | Positive | 0 | 0 | 12 | 36 | 43 |
| | Total | 44 | 44 | 48 | 43 | 43 |
| | Agreement | 100% | 100% | 75% | 83.7% | 100% |
| BAR 300 ng/mL | Negative | 24 | 20 | 16 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 24 |
| | Total | 24 | 20 | 21 | 20 | 24 |
| | Agreement | 100% | 100% | 76.2% | 80% | 100% |
| BUP 10 ng/mL | Negative | 24 | 20 | 16 | 6 | 0 |
| | Positive | 0 | 0 | 6 | 18 | 20 |
| | Total | 24 | 20 | 22 | 24 | 20 |
| | Agreement | 100% | 100% | 72.7% | 75% | 100% |
{21}
| BZO
300 ng/mL | Negative | 21 | 20 | 18 | 4 | 0 |
| --- | --- | --- | --- | --- | --- | --- |
| | Positive | 0 | 0 | 6 | 16 | 21 |
| | Total | 21 | 20 | 24 | 20 | 21 |
| | Agreement | 100% | 100% | 75% | 80% | 100% |
| COC
150 ng/mL | Negative | 20 | 24 | 18 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 17 | 21 |
| | Total | 20 | 24 | 24 | 21 | 21 |
| | Agreement | 100% | 100% | 75% | 80.9% | 100% |
| EDDP
300 ng/mL | Negative | 22 | 24 | 15 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 14 | 22 |
| | Total | 22 | 24 | 20 | 20 | 22 |
| | Agreement | 100% | 100% | 75% | 70% | 100% |
| MET
500 ng/mL | Negative | 21 | 21 | 14 | 5 | 0 |
| | Positive | 0 | 0 | 6 | 19 | 20 |
| | Total | 21 | 21 | 20 | 24 | 20 |
| | Agreement | 100% | 100% | 70% | 75% | 100% |
| MDMA
500 ng/mL | Negative | 20 | 22 | 14 | 6 | 0 |
| | Positive | 0 | 0 | 6 | 18 | 22 |
| | Total | 20 | 22 | 20 | 24 | 22 |
| | Agreement | 100% | 100% | 70% | 75% | 100% |
| MTD
300 ng/mL | Negative | 22 | 22 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 7 | 17 | 24 |
| | Total | 22 | 22 | 20 | 20 | 24 |
| | Agreement | 100% | 100% | 65% | 85% | 100% |
| MOR
300 ng/mL | Negative | 20 | 21 | 16 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 18 | 23 |
| | Total | 20 | 21 | 21 | 24 | 23 |
| | Agreement | 100% | 100% | 76% | 75% | 100% |
| OPI
2000 ng/mL | Negative | 20 | 22 | 17 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 24 |
| | Total | 20 | 22 | 22 | 20 | 24 |
| | Agreement | 100% | 100% | 77.2% | 80% | 100% |
| OXY
100 ng/mL | Negative | 24 | 24 | 16 | 3 | 0 |
| | Positive | 0 | 0 | 6 | 19 | 20 |
| | Total | 24 | 24 | 22 | 22 | 20 |
| | Agreement | 100% | 100% | 72.7% | 86.4% | 100% |
| PCP
25 ng/ML | Negative | 24 | 24 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 7 | 18 | 20 |
| | Total | 24 | 24 | 20 | 21 | 20 |
| | Agreement | 100% | 100% | 65% | 95.7% | 100% |
| TCA
1000 ng/mL | Negative | 24 | 20 | 18 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 18 | 20 |
| | Total | 24 | 20 | 24 | 22 | 20 |
| | Agreement | 100% | 100% | 75% | 81.8% | 100% |
| THC | Negative | 20 | 21 | 15 | 5 | 0 |
22
{22}
Dip card
| | | Drug Concentration | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | +25% | +50% |
| AMP 500 ng/mL | Negative | 41 | 45 | 29 | 8 | 0 |
| | Positive | 0 | 0 | 11 | 36 | 42 |
| | Total | 41 | 45 | 40 | 44 | 42 |
| | Agreement | 100% | 100% | 72.5% | 81.8% | 100% |
| BAR 300 ng/mL | Negative | 24 | 20 | 17 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 14 | 20 |
| | Total | 24 | 20 | 22 | 20 | 20 |
| | Agreement | 100% | 100% | 77.3% | 70% | 100% |
| BUP 10 ng/mL | Negative | 20 | 22 | 17 | 4 | 0 |
| | Positive | 0 | 0 | 4 | 17 | 21 |
| | Total | 20 | 22 | 21 | 21 | 21 |
| | Agreement | 100% | 100% | 81% | 81% | 100% |
| BZO 300 ng/mL | Negative | 23 | 20 | 16 | 4 | 0 |
| | Positive | 0 | 0 | 4 | 16 | 22 |
| | Total | 23 | 20 | 20 | 20 | 22 |
| | Agreement | 100% | 100% | 80% | 80% | 100% |
| COC 150 ng/mL | Negative | 20 | 20 | 19 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 18 | 23 |
| | Total | 20 | 20 | 24 | 22 | 23 |
| | Agreement | 100% | 100% | 79.1% | 81.8% | 100% |
| EDDP 300 ng/mL | Negative | 20 | 21 | 16 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 21 |
| | Total | 20 | 21 | 21 | 22 | 21 |
| | Agreement | 100% | 100% | 76.2% | 72.7% | 100% |
| MET 500 ng/mL | Negative | 23 | 22 | 14 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 20 |
| | Total | 23 | 22 | 20 | 20 | 20 |
| | Agreement | 100% | 100% | 70% | 80% | 100% |
| MDMA 500 ng/mL | Negative | 22 | 20 | 16 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 14 | 21 |
| | Total | 22 | 20 | 21 | 20 | 21 |
| | Agreement | 100% | 100% | 76.2% | 70% | 100% |
| MTD 300 ng/mL | Negative | 20 | 0 | 16 | 5 | 0 |
| | Positive | 0 | 21 | 6 | 16 | 20 |
| | Total | 20 | 21 | 22 | 21 | 20 |
| | Agreement | 100% | 100% | 72.7% | 76.2% | 100% |
| MOR | Negative | 20 | 23 | 17 | 4 | 0 |
{23}
| 300 ng/mL | Positive | 0 | 0 | 5 | 20 | 20 |
| --- | --- | --- | --- | --- | --- | --- |
| | Total | 20 | 23 | 22 | 24 | 20 |
| | Agreement | 100% | 100% | 77.3% | 83.4% | 100% |
| OPI 2000 ng/mL | Negative | 22 | 21 | 15 | 5 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 20 |
| | Total | 22 | 21 | 20 | 21 | 20 |
| | Agreement | 100% | 100% | 75% | 76.2% | 100% |
| OXY 100 ng/mL | Negative | 21 | 20 | 16 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 21 |
| | Total | 21 | 20 | 21 | 20 | 21 |
| | Agreement | 100% | 100% | 76.2% | 80% | 100% |
| PCP 25 ng/ML | Negative | 24 | 20 | 15 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 18 | 20 |
| | Total | 24 | 20 | 20 | 22 | 20 |
| | Agreement | 100% | 100% | 75% | 81.8% | 100% |
| TCA 1000 ng/mL | Negative | 20 | 21 | 16 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 17 | 22 |
| | Total | 20 | 21 | 21 | 21 | 22 |
| | Agreement | 100% | 100% | 76.2% | 80.9% | 100% |
| THC 50 ng/mL | Negative | 20 | 22 | 17 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 24 |
| | Total | 20 | 22 | 23 | 20 | 24 |
| | Agreement | 100% | 100% | 73.9% | 80% | 100% |
Cup
| | | Drug Concentration | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Drug | Result | Negative | -50% | -25% | +25% | +50% |
| AMP 500 ng/mL | Negative | 90 | 82 | 61 | 22 | 0 |
| | Positive | 0 | 0 | 23 | 68 | 86 |
| | Total | 90 | 82 | 84 | 90 | 86 |
| | Agreement | 100% | 100% | 72.8% | 75.5% | 100% |
| BAR 300 ng/mL | Negative | 152 | 21 | 15 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 15 | 21 |
| | Total | 152 | 21 | 20 | 21 | 21 |
| | Agreement | 100% | 100% | 75% | 71.4% | 100% |
| BUP 10 ng/mL | Negative | 148 | 21 | 18 | 6 | 0 |
| | Positive | 0 | 0 | 4 | 18 | 20 |
| | Total | 148 | 21 | 22 | 24 | 20 |
| | Agreement | 100% | 100% | 81.8% | 75% | 100% |
| BZO 300 ng/mL | Negative | 154 | 21 | 15 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 17 | 20 |
| | Total | 154 | 21 | 21 | 21 | 20 |
| | Agreement | 100% | 100% | 71.4% | 80.9% | 100% |
| COC | Negative | 152 | 21 | 15 | 5 | 0 |
{24}
| 150 ng/mL | Positive | 0 | 0 | 6 | 15 | 23 |
| --- | --- | --- | --- | --- | --- | --- |
| | Total | 152 | 21 | 21 | 20 | 23 |
| | Agreement | 100% | 100% | 71.4% | 75% | 100% |
| EDDP 300 ng/mL | Negative | 150 | 24 | 14 | 5 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 22 |
| | Total | 150 | 24 | 20 | 21 | 22 |
| | Agreement | 100% | 100% | 70% | 76.2% | 100% |
| MET 500 ng/mL | Negative | 154 | 20 | 15 | 5 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 21 |
| | Total | 154 | 20 | 21 | 21 | 21 |
| | Agreement | 100% | 100% | 71.4% | 76.2% | 100% |
| MDMA 500 ng/mL | Negative | 148 | 23 | 15 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 15 | 22 |
| | Total | 148 | 23 | 20 | 21 | 22 |
| | Agreement | 100% | 100% | 75% | 71.4% | 100% |
| MTD 300 ng/mL | Negative | 150 | 22 | 16 | 5 | 0 |
| | Positive | 0 | 0 | 5 | 15 | 24 |
| | Total | 150 | 22 | 21 | 20 | 24 |
| | Agreement | 100% | 100% | 76.2% | 75% | 100% |
| MOR 300 ng/mL | Negative | 84 | 23 | 14 | 5 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 21 |
| | Total | 84 | 23 | 20 | 21 | 21 |
| | Agreement | 100% | 100% | 70% | 76.2% | 100% |
| OPI 2000 ng/mL | Negative | 84 | 22 | 18 | 4 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 21 |
| | Total | 84 | 22 | 23 | 20 | 21 |
| | Agreement | 100% | 100% | 78.3% | 80% | 100% |
| OXY 100 ng/mL | Negative | 151 | 21 | 15 | 5 | 0 |
| | Positive | 0 | 0 | 7 | 18 | 20 |
| | Total | 151 | 21 | 22 | 23 | 20 |
| | Agreement | 100% | 100% | 68.2% | 78.3% | 100% |
| PCP 25 ng/ML | Negative | 152 | 21 | 15 | 4 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 21 |
| | Total | 152 | 21 | 21 | 20 | 21 |
| | Agreement | 100% | 100% | 71.4% | 80% | 100% |
| TCA 1000 ng/mL | Negative | 148 | 20 | 19 | 6 | 0 |
| | Positive | 0 | 0 | 5 | 16 | 21 |
| | Total | 148 | 20 | 24 | 22 | 21 |
| | Agreement | 100% | 100% | 79.2% | 72.7% | 100% |
| THC 50 ng/mL | Negative | 152 | 20 | 17 | 5 | 0 |
| | Positive | 0 | 0 | 6 | 16 | 21 |
| | Total | 152 | 20 | 23 | 21 | 21 |
| | Agreement | 100% | 100% | 73.9% | 76.2% | 100% |
{25}
A post-test survey of volunteers showed that 100% thought that the test was easy to use and easy to read. A Flesh-Kincaid reading analysis resulted in a reading grade level of 7.8.
## Read Time
Drug standards at the concentration of 0, -50% and +50% cutoff level were tested in triplicates with the Advin Multi-Drug Screen Test Cassettes, Dip Card and Cup formats following the procedures described in the proposed package inserts. The result was read visually as positive or negative at 5, 10, 30, 60 and 120 minutes. Results showed that the test results are stable for up to 120 minutes.
## Adulteration Testing
To demonstrate that the technicians at POC sites are able to follow the product package insert to perform Advin urine adulteration test when the urine adulteration strips are included in Advin Multi-drug Screen Test Cassette, Dip Card and Cup, drug standards were spiked into drug-free urine samples at 0% cutoff, -50% cutoff, -25% cutoff, at cutoff, +25% cutoff and +50% cutoff, and bleach, nitrate, sodium chloride, and glutaraldehyde were spiked into samples as adulterants. Each adultered sample was tested in triplicates on each of the Advin Urine Adulteration test formats, by three office technicians at three POC sites. Results showed that the Advin Urine Adulteration tests were able to detect adulteration under these specific conditions 100% of the time.
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 Part 809.10.
## O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
