ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
Device Facts
| Record ID | K050024 |
|---|---|
| Device Name | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. |
| Product Code | DIS · Clinical Toxicology |
| Decision Date | Nov 17, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3150 |
| Device Class | Class 2 |
Indications for Use
The One Step Multiple Drugs of Abuse Assays is intended for the qualitative determination of drugs and their metabolisms In human urine. They are intended for the healthcare professional use including professionals at point-of-care sites.
Device Story
Lateral flow immunochromatographic assay; detects drugs of abuse in urine. Input: urine sample; reaction initiated by sample movement through test strip. Principle: competitive binding between drug in sample and drug-labeled conjugate for antibody binding sites. Output: visual presence/absence of test line; internal process control line confirms sample volume/strip integrity. Used by healthcare professionals; not for point-of-care. Preliminary results require GC/MS confirmation. Assists in diagnosis/treatment of drug use or overdose.
Clinical Evidence
No clinical studies performed. Analytical performance validated via precision studies (90 replicates per concentration per lot) and method comparison against GC/MS reference method using 80 clinical samples per analyte. Results demonstrated high agreement with GC/MS values.
Technological Characteristics
Lateral flow immunochromatographic assay. Uses monoclonal mouse antibodies for drug detection and polyclonal goat anti-mouse antibody for control line. Formats: dipstick, multi-drug panel, or cassette. Visual readout. No instrumentation required. Qualitative result.
Indications for Use
Indicated for qualitative determination of drugs of abuse in urine for healthcare professional use. Includes Amphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methamphetamine, MDMA, Morphine, Opiates, Phencyclidine, and Tricyclic Antidepressants. Not for point-of-care settings.
Regulatory Classification
Identification
A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A barbiturate 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
- ACON, Inc One Step Drug Screening Test Card (K020771)
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
k050024
B. Purpose for Submission:
New Device
C. Measurands:
Amphetamine, Barbiturates, Benzodiazepines, Marijuana, Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Phencyclidine, and Tricyclic Antidepressants
D. Type of Test:
Qualitative immunoassay
E. Applicant:
Guangzhou Wondfo Biotech Co, Ltd.
F. Proprietary and Established Names:
One Step Urine Test for Amphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Phencyclidine, and Tricyclic Antidepressants.
One Step Multi-Drug Urine Test Panel
G. Regulatory Information:
1. Regulation section:
21 CFR 862.3100, 862.3150, 862.3170, 862.3870, 862.3250, 862.3620, 862.3610, 862.3640, 862.3650, 862.3910
2. Classification:
All class II
3. Product Codes:
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DPK, DJG, LCM, LFG
4. Panel:
Toxicology (91)
{1}
Page 2 of 32
H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine:
| Product Name | Cutoff |
| --- | --- |
| Amphetamine (amphetamine) | 1000 ng/ml |
| Barbiturates (secobarbital) | 300 ng/ml |
| Benzodiazipines (oxazepam) | 300 ng/ml |
| Cocaine (benzoylecgonine) | 300 ng/ml |
| Methamphetamine (methamphetamine) | 1000 ng/ml |
| Morphine (morphine) | 300 ng/ml |
| Opiates (morphine) | 2000 ng/ml |
| Methadone (methadone) | 300 ng/ml |
| Methylenedioxymethamphetamine (methylenedioxymethamphetamine) | 500 ng/ml |
| Phencyclidine (phencyclidine) | 25 ng/ml |
| Tricyclic antidepressant drugs (nortriptyline) | 1000 ng/ml |
| Cannabinoids (tetrahydrocannabinol-COOH) | 50 ng/ml |
The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
{2}
Page 3 of 32
3. Special condition for use statement(s):
The Guangzhou Wondfo assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/Mass spectrometry is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The assay is not designated for use in point-of-care settings.
Tests for barbiturates, benzodiazepines, opiates, and tricyclic antidepressants cannot distinguish between abused drugs and certain prescribed medications.
Certain foods or medications may interfere with tests for amphetamines and opiates and cause false positive results.
4. Special instrument Requirements:
Not applicable. The devices are visually read single-use devices.
I. Device Description:
The sponsor has included data from three different configurations, all of which use the same strip(s). One configuration is a single-use dipstick device. Operators dip the test strip into the urine and the reaction is initiated by movement of the sample through the test strip. The second configuration combines from 2 to 12 strips in a multi-drug urine test panel. Operators dip the test strips into the urine and the reaction is initiated by movement of the sample through the test strips. The third configuration uses the same strips in a cassette format. Operators add several drops of the sample to the sample well. The test reaction is initiated by movement of the sample through the test strip.
J. Substantial Equivalence Information:
1. Predicate device name(s):
ACON, Inc One Step Drug Screening Test Card
2. Predicate K number(s):
K020771
{3}
Page 4 of 32
3. Comparison with predicate:
Both devices are for the qualitative determination of the same analyte(s) in the same matrix, and utilize the same cutoff concentration. Both are visually-read single use devices. The reagent formulations vary between the two devices.
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Calibrator | Same | Amphetamine (d-amphetamine)
Methamphetamine (d-methamphetamine)
Cocaine (Benzoylecgonine)
Cannabinoids (11-nor-delta-9-THC-9-COOH)
Phencyclidine (Phencyclidine)
Morphine (Morphine)
Opiates (Morphine)
Methadone (Methadone)
Barbiturates (Secobarbital)
Benzodiazepines (Oxazepam) |
| Antibodies | Same | Mouse, Monoclonal |
| Methodology | Same | Qualitative Lateral Flow Immunochromatographic |
| Internal Control | Same | Procedural control indicates adequate sample volume and integrity of the strip |
| Differences | | |
| Item | Device | Predicate |
| Calibrator | TCA (Nortryptyline)
MDMA (Methylenedioxy methamphetamine) | TCA, MDMA not included |
| Point of Care Use | No | Yes |
| Configurations | Strip, Cassette, Multi-Drug Test Panel | Test Card, Test Card with Integrated Cup |
K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in their submission.
L. Test Principle:
The test employs lateral flow immunochromatographic technology.
Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.
{4}
Page 5 of 32
The device also has an internal process control which indicates that an adequate volume of sample has been added and that the immunochromatographic strip is intact.
Description of the test antibodies: monoclonal mouse antibody against d-amphetamine, d-methamphetamine, Benzoylecgonine, 11-nor-delta-9-THC-9-COOH, Phencyclidine, Morphine (for both the morphine and opiates assay), Methadone, Secobarbital, Oxazepam, Nortryptyline, and Methylenedioxymethamphetamine.
Description of the control line antibody: Polyclonal Goat anti-Mouse
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
To assess the precision of the device, the sponsor used both spiked and clinical samples. The spiked samples were prepared at the following concentrations: cutoff – 50%, cutoff – 25%, cutoff, cutoff +25%, and the cutoff + 50%. All samples were analyzed with GC-MS to confirm the concentration. Each concentration was then tested using three lots of the candidate device. For each drug, thirty samples (five clinical and 25 spiked) were analyzed at each concentration, and each result was read by three viewers, for a total of 90 results per concentration per lot. See summary data below.
Specimen description: drug free urine spiked with d-amphetamine, d-methamphetamine, benzoylecgonine, 11-nor-delta-9-THC-9-COOH, phencyclidine, morphine (for both the morphine and opiates assay), methadone, secobarbital, oxazepam, nortryptyline, and methylenedioxymethamphetamine. The sponsor also used clinical samples containing the same compounds. The study protocol was the same for all 12 analytes:
Number of days: one
Replicates per day: at each concentration, 90 replicates per lot
Lots of product used: three
Number of operators: three
Operator: laboratorian
Testing Facility: manufacturer
Results of the studies are presented below:
{5}
Page 6 of 32
# Cocaine Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 82/8 |
| 300 | 90 | 53/37 |
| 375 | 90 | 13/77 |
| 450 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 80/10 |
| 300 | 90 | 36/54 |
| 375 | 90 | 13/77 |
| 450 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 80/10 |
| 300 | 90 | 36/54 |
| 375 | 90 | 13/77 |
| 450 | 90 | 0/90 |
# Barbiturates Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 79/11 |
| 300 | 90 | 42/48 |
| 375 | 90 | 18/72 |
| 450 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 79/11 |
| 300 | 90 | 42/48 |
| 375 | 90 | 18/72 |
| 450 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 79/11 |
| 300 | 90 | 42/48 |
| 375 | 90 | 18/72 |
| 450 | 90 | 0/90 |
{6}
Page 7 of 32
# Cannabinoid (THC) Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 25 | 90 | 90/0 |
| 38 | 90 | 76/14 |
| 50 | 90 | 43/47 |
| 63 | 90 | 12/78 |
| 75 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 25 | 90 | 90/0 |
| 38 | 90 | 76/14 |
| 50 | 90 | 43/47 |
| 63 | 90 | 12/78 |
| 75 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 25 | 90 | 90/0 |
| 38 | 90 | 76/14 |
| 50 | 90 | 43/47 |
| 63 | 90 | 12/78 |
| 75 | 90 | 0/90 |
# Opiates Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 1000 | 90 | 90/0 |
| 1500 | 90 | 80/10 |
| 2000 | 90 | 44/46 |
| 2500 | 90 | 12/78 |
| 3000 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 1000 | 90 | 90/0 |
| 1500 | 90 | 80/10 |
| 2000 | 90 | 44/46 |
| 2500 | 90 | 12/78 |
| 3000 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 1000 | 90 | 90/0 |
| 1500 | 90 | 80/10 |
| 2000 | 90 | 44/46 |
| 2500 | 90 | 12/78 |
| 3000 | 90 | 0/90 |
{7}
Page 8 of 32
# PCP Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 13 | 90 | 90/0 |
| 17 | 90 | 93/7 |
| 25 | 90 | 47/43 |
| 32 | 90 | 14/76 |
| 38 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 13 | 90 | 90/0 |
| 17 | 90 | 93/7 |
| 25 | 90 | 47/43 |
| 32 | 90 | 14/76 |
| 38 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 13 | 90 | 90/0 |
| 17 | 90 | 93/7 |
| 25 | 90 | 47/43 |
| 32 | 90 | 14/76 |
| 38 | 90 | 0/90 |
# Amphetamine Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 32/58 |
| 1250 | 90 | 14/76 |
| 1500 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 32/58 |
| 1250 | 90 | 14/76 |
| 1500 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 32/58 |
| 1250 | 90 | 14/76 |
| 1500 | 90 | 0/90 |
{8}
Page 9 of 32
# TCA Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 41/49 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 41/49 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 78/12 |
| 1000 | 90 | 41/49 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
# Benzodiazepines Precision Study Results
Lot 1
| concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 79/11 |
| 300 | 90 | 41/49 |
| 375 | 90 | 9/81 |
| 450 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 79/11 |
| 300 | 90 | 41/49 |
| 375 | 90 | 11/79 |
| 450 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 80/10 |
| 300 | 90 | 41/49 |
| 375 | 90 | 11/79 |
| 450 | 90 | 0/90 |
{9}
Page 10 of 32
# Morphine Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 77/13 |
| 300 | 90 | 28/62 |
| 375 | 90 | 8/82 |
| 450 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 77/13 |
| 300 | 90 | 28/62 |
| 375 | 90 | 8/82 |
| 450 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 77/13 |
| 300 | 90 | 28/62 |
| 375 | 90 | 6/84 |
| 450 | 90 | 0/90 |
# Methadone Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 75/15 |
| 300 | 90 | 41/49 |
| 375 | 90 | 7/83 |
| 450 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 75/15 |
| 300 | 90 | 41/49 |
| 375 | 90 | 7/83 |
| 450 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 150 | 90 | 90/0 |
| 225 | 90 | 75/15 |
| 300 | 90 | 41/49 |
| 375 | 90 | 7/83 |
| 450 | 90 | 0/90 |
{10}
Page 11 of 32
MDMA Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 250 | 90 | 90/0 |
| 325 | 90 | 86/14 |
| 500 | 90 | 30/50 |
| 625 | 90 | 9/81 |
| 750 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 250 | 90 | 90/0 |
| 325 | 90 | 86/14 |
| 500 | 90 | 30/50 |
| 625 | 90 | 9/81 |
| 750 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 250 | 90 | 90/0 |
| 325 | 90 | 86/14 |
| 500 | 90 | 30/50 |
| 625 | 90 | 9/81 |
| 750 | 90 | 0/90 |
Methamphetamine Precision Study Results
Lot 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 81/9 |
| 1000 | 90 | 34/56 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
Lot 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 81/9 |
| 1000 | 90 | 34/56 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
Lot 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 500 | 90 | 90/0 |
| 750 | 90 | 81/9 |
| 1000 | 90 | 34/56 |
| 1250 | 90 | 13/77 |
| 1500 | 90 | 0/90 |
{11}
Page 12 of 32
The sponsor also conducted a bridging study to demonstrate comparable performance between the strip format and the cassette format. Note: the multi-strip format is not housed in plastic but consists of multiple strips with a holder. Since these are dipped and read in the same manner as the single dipsticks, they were not included in the bridging study.
## Amphetamines Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 1/59 | 0/60 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
## Barbiturates Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 0/60 | 1/59 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
## Benzodiazepines Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 0/60 | 1/59 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
## Cocaine Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 60/0 | 98 |
| Cutoff | 2/58 | 0/60 | 97 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
{12}
Page 13 of 32
MDMA Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 60/0 | 58/2 | 97 |
| Cutoff | 0/60 | 1/59 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
Marijuana Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 58/2 | 60/0 | 97 |
| Cutoff | 1/59 | 1/59 | 100 |
| Cutoff + 25% | 0/60 | 1/59 | 98 |
Methamphetamine Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 60/0 | 98 |
| Cutoff | 1/59 | 0/60 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
Morphine Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 1/59 | 1/59 | 100 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
Methadone Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 2/58 | 0/60 | 97 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
{13}
Page 14 of 32
Opiates Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 60/0 | 98 |
| Cutoff | 1/59 | 0/60 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
Phencyclidine Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 59/1 | 59/1 | 100 |
| Cutoff | 1/59 | 0/60 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
Tricyclic Antidepressants Bridging Study
| Concentration | Strip Results (neg/pos) | Cassette Results (neg/pos) | % Agreement |
| --- | --- | --- | --- |
| Cutoff -25% | 60/0 | 58/2 | 97 |
| Cutoff | 1/59 | 0/60 | 98 |
| Cutoff + 25% | 1/59 | 0/60 | 98 |
b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.
c. Traceability (controls, calibrators, or method):
This device has an internal process control. A colored line appearing in the control region confirms that sufficient sample volume has traveled along the strip and that the membrane is intact. Users are informed that the test is invalid if a colored line fails to appear in the control region. External controls are not supplied with this device; however, users are instructed to follow federal, state, and local guidelines when determining when to run external controls.
{14}
Page 15 of 32
d. Detection limit:
Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result. This information appears in the precision section, above.
e. Analytical specificity:
Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine /a negative control. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below:
Amphetamine
| Drug Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| d,l-3,4-Methylenedioxymethamphetamine (MDMA) | 300 |
| d-amphetamine | 1,000 |
| d-methamphetamine | 1,000 |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | 2,000 |
| dl-amphetamine | 3,000 |
| Phentermine | 3,000 |
| l-methamphetamine | 3,000 |
| 3,4-Methylenedioxyamphetamine (MDA) | 5,000 |
| l-amphetamine | 50,000 |
Methamphetamine
| Drug Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | 600 |
| d-methamphetamine | 1,000 |
| D,L 3,4-Methylenedioxymethamphetamine (MDMA) | 2,000 |
| 3,4-Methylenedioxyamphetamine (MDA) | 3,000 |
| l-methamphetamine | 8,000 |
| trimethobenzamide | 10,000 |
| d-amphetamine | 50,000 |
| l-amphetamine | 50,000 |
| β-phenylethylamine | 50,000 |
| chloroquine | 50,000 |
| ephedrine | 50,000 |
{15}
Page 16 of 32
MDMA
| Drug Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | 300 |
| D,L 3,4-Methylenedioxymethamphetamine (MDMA) | 500 |
| 3,4-Methylenedioxyamphetamine (MDA) | 3,000 |
| d-methamphetamine | 8,000 |
| l-methamphetamine | 10,000 |
| d-amphetamine | 50,000 |
| l-amphetamine | 60,000 |
Morphine (cutoff 300 ng/mL)
| Drug compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Codeine | 300 |
| Heroin | 300 |
| Morphine | 300 |
| Ethylmorphine | 300 |
| 6-monoacetylmorphine | 400 |
| Morphine-3-β-glucuronide | 1,000 |
| Hydrocodone | 5,000 |
| Hydromorphone | 5,000 |
| Oxycodone | 30,000 |
| Thebaine | 30,000 |
Opiates (cutoff 1000 ng/mL)
| Drug compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Codeine | 2,000 |
| Heroin | 2,000 |
| Morphine | 2,000 |
| Morphine-3-β-glucuronide | 2,000 |
| 6-monoacetylmorphine | 5,000 |
| Hydromorphone | 5,000 |
| Ethylmorphine | 5,000 |
| Hydrocodone | 12,500 |
| Norcodeine | 12,500 |
| Oxycodone | 25,000 |
| Normorphone | 50,000 |
| Levorphanol | 75,000 |
| Thebaine | 100,000 |
| Procaine | 150,000 |
{16}
Page 17 of 32
## Cocaine
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Benzoylecogonine | 300 |
| Cocaine HCl | 750 |
| Cocaethylene | 12,500 |
| Ecgonine | 32,000 |
## Cannabinoids (THC)
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 11-Nor-Δ⁸-Tetrahydrocannabinol carboxylic acid | 30 |
| 11-Nor-Δ⁹-Tetrahydrocannabinol carboxylic acid | 50 |
| 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 2,500 |
| Δ⁸-Tetrahydrocannabinol | 7,500 |
| Δ⁹-Tetrahydrocannabinol | 10,000 |
| Cannabinol | 10,000 |
| Cannabidiol | 100,000 |
## Phencyclidine
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Phencyclidine | 25 |
| Phencyclidine Morpholine | 50 |
| 4-hydroxyphencyclidine | 12,500 |
## Barbiturates
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Butabarbital | 75 |
| Phenobarbital | 100 |
| Butethal | 100 |
| Alphenol | 150 |
| Aprobarbital | 200 |
| Secobarbital | 300 |
| Pentobarbital | 300 |
| Amobarbital | 300 |
| Cyclopentobarbital | 600 |
| Butalbital | 2,500 |
{17}
Page 18 of 32
Benzodiazepines
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Nitrazepam | 100 |
| Clobazam | 100 |
| Temazepam | 100 |
| Alprazolam | 200 |
| Diazepam | 200 |
| Clorazepate dipotassium | 200 |
| Norchlordiazepoxide | 200 |
| Oxazepam | 300 |
| Flunitrazepam | 400 |
| Nordiazepam | 400 |
| Clonazepam | 800 |
| Chlordiaepoxide | 1,500 |
| Lorazepam | 1,500 |
| α – hydroxyalprazolam | 1,500 |
| Bromazepam | 1,500 |
| Delorazepam | 1,500 |
| Estazolam | 2,500 |
| Trazolam | 2,500 |
| Midazolam | 12,500 |
Methadone
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Methadone | 300 |
| Doxylamine | 50,000 |
Tricyclic Antidepressants (TCA)
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Desipramine | 200 |
| Imipramine | 400 |
| Nortriptyline | 1,000 |
| Nordoxepine | 1,000 |
| Amitriptyline | 1,500 |
| Promazine | 1,500 |
| Doxepine | 2,000 |
| Maprotiline | 2,000 |
| Trimipramine | 3,000 |
| Clomipramine | 12,500 |
| Promethazine | 25,000 |
{18}
Page 19 of 32
To evaluate for interference the sponsor prepared three control samples for all 12 analytes: drug-free urine, drug-free urine spiked to an analyte concentration 50% below the cutoff, and drug-free urine spiked to an analyte concentration 50% above the cutoff of the targeted drug. 100 µg/mL of potentially interfering compounds were then added to separate aliquots of the control samples and analyzed. There were no deviations from the expected results; i.e., the drug-free and cutoff – 50% samples all read negative, and the cutoff + 50% sample all read positive. All of the compounds tested are listed in the package inserts.
There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.
To test for potential positive and negative interference from endogenous conditions the sponsor prepared two control samples, one with drug-free urine spiked to an analyte concentration 50% below the cutoff, and one with drug-free urine spiked to 50% above the cutoff of the targeted drug. Aliquots of the control samples were then altered to span the following ranges of conditions, and analyzed:
4-9 pH
1.000 to 1.035 specific gravity
There was no change in test results as compared to the results of the control sample. The sponsor did not evaluate the effects albumin on the assay.
f. Assay cut-off:
Of the 12 analytes in this submission, six use cutoffs recommended for use by the Substance Abuse and Mental Health Services Administration (SAMHSA): cannabinoids, cocaine, opiates, phencyclidine, amphetamines, and MDMA (methylenedioxymethamphetamine). SAMHSA has not recommended cutoff concentrations for the other six analytes.
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above.
2. Comparison studies:
a. Method comparison with predicate device:
Because the candidate device was compared to a reference method, GC/MS, it was not compared to a predicate device.
{19}
Page 20 of 32
Sample description: Unaltered clinical urine samples were evaluated. A portion of samples having drug concentrations that were below the cutoff concentration of the assay were also evaluated by GC/MS.
The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. Approximately 40% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration.
Number of study sites: one
Type of study site: Manufacturer's facility
Operator description: Manufacturer's staff
# Candidate Device Results vs. stratified GC/MS Values - Amphetamine
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 4 | 11 | 29 |
| Negative | 28 | 8 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 90%
Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 11 | 29 |
| Negative | 28 | 11 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 98%
{20}
Page 21 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 5 | 11 | 29 |
| Negative | 28 | 7 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 88%
GC/MS values used to categorize samples in these tables are based on the concentration of d-amphetamine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values – Barbiturate
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 4 | 15 | 20 |
| Negative | 20 | 16 | 5 | 0 |
% Agreement among positives is 88%
% Agreement among negatives is 90%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 18 | 20 |
| Negative | 20 | 18 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 95%
{21}
Page 22 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 18 | 20 |
| Negative | 20 | 17 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 93%
GC/MS values used to categorize samples in these tables are based on the concentration of secobarbital found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Benzodiazepines
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 17 | 20 |
| Negative | 20 | 18 | 3 | 0 |
% Agreement among positives is 93%
% Agreement among negatives is 95%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 20 | 20 |
| Negative | 20 | 19 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 98%
{22}
Page 23 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 18 | 20 |
| Negative | 20 | 17 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 93%
GC/MS values used to categorize samples in these tables are based on the concentration of oxazepam found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Cocaine
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 11 | 29 |
| Negative | 20 | 19 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 98%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 9 | 29 |
| Negative | 20 | 19 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 98%
{23}
Page 24 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 9 | 29 |
| Negative | 20 | 18 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 95%
GC/MS values used to categorize samples in these tables are based on the concentration of benzoylecgonine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Cannabinoids
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 4 | 18 | 22 |
| Negative | 22 | 14 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 90%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 17 | 22 |
| Negative | 22 | 18 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 100%
{24}
Page 25 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 15 | 22 |
| Negative | 22 | 18 | 3 | 0 |
% Agreement among positives is 93%
% Agreement among negatives is 100%
GC/MS values used to categorize samples in these tables are based on the concentration of 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Methadone
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 17 | 21 |
| Negative | 22 | 18 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 100%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 18 | 21 |
| Negative | 22 | 18 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 100%
{25}
Page 26 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 18 | 21 |
| Negative | 22 | 18 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 100%
GC/MS values used to categorize samples in these tables are based on the concentration of methadone found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Methamphetamine
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 5 | 19 | 20 |
| Negative | 26 | 9 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 88%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 2 | 3 | 19 | 20 |
| Negative | 24 | 11 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 88%
{26}
Page 27 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 1 | 5 | 18 | 20 |
| Negative | 25 | 9 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 85%
GC/MS values used to categorize samples in these tables are based on the concentration of d-methamphetamine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - MDMA
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 19 | 20 |
| Negative | 20 | 20 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 100%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 19 | 20 |
| Negative | 20 | 17 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 93%
{27}
Page 28 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 19 | 20 |
| Negative | 20 | 18 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 95%
GC/MS values used to categorize samples in these tables are based on the concentration of d,l-3,4-Methylenedioxymethamphetamine (MDMA) found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Morphine
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 19 | 20 |
| Negative | 29 | 8 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 93%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 19 | 20 |
| Negative | 29 | 8 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 93%
{28}
Page 29 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 4 | 19 | 20 |
| Negative | 29 | 7 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 90%
GC/MS values used to categorize samples in these tables are based on the concentration of morphine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Opiate
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 16 | 22 |
| Negative | 30 | 8 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 95%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 17 | 22 |
| Negative | 30 | 9 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 98%
{29}
Page 30 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 16 | 22 |
| Negative | 30 | 9 | 2 | 0 |
% Agreement among positives is 95%
% Agreement among negatives is 98%
GC/MS values used to categorize samples in these tables are based on the concentration of morphine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - Phencyclidine
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 15 | 22 |
| Negative | 23 | 17 | 3 | 0 |
% Agreement among positives is 93%
% Agreement among negatives is 100%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 17 | 22 |
| Negative | 23 | 17 | 1 | 0 |
% Agreement among positives is 98%
% Agreement among negatives is 100%
{30}
Page 31 of 32
## Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 15 | 22 |
| Negative | 23 | 16 | 3 | 0 |
% Agreement among positives is 93%
% Agreement among negatives is 98%
GC/MS values used to categorize samples in these tables are based on the concentration of phencyclidine found in the sample.
## Candidate Device Results vs. stratified GC/MS Values - TCA
A total of 80 samples (40 negative and 40 positive) were evaluated by the candidate device and by GC/MS. Each test device was read by three readers.
## Reader A
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 10 | 30 |
| Negative | 29 | 11 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 100%
## Reader B
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 10 | 30 |
| Negative | 29 | 9 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 95%
{31}
Page 32 of 32
Reader C
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 10 | 30 |
| Negative | 29 | 11 | 0 | 0 |
% Agreement among positives is 100%
% Agreement among negatives is 100%
GC/MS values used to categorize samples in these tables are based on the concentration of nortriptyline found in the sample.
b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.
3. Clinical studies:
a. Clinical sensitivity:
Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):
4. Clinical cut-off:
Not applicable.
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.
