SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
Device Facts
| Record ID | K153646 |
|---|---|
| Device Name | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana |
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd. |
| Product Code | DIO · Clinical Toxicology |
| Decision Date | Mar 18, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
Indications for Use
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Device Story
SAFECARE Urine Test devices are lateral flow immunochromatographic assays for qualitative detection of drugs of abuse (Amphetamine, Cocaine/Benzoylecgonine, Marijuana/Cannabinoids) in human urine. Available in Cassette, Cup, and DipCard formats. Device includes test device, package insert, and urine cup. Used by lay users (OTC) or clinicians (prescription) for preliminary screening. Urine sample migrates via capillary action; competitive binding principle used. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored line. If drug concentration exceeds cutoff, binding sites are saturated, preventing line formation. Control line forms regardless of drug presence. Results are visually read by the user. Positive results require confirmation via GC/MS. Benefits include rapid, preliminary identification of drug presence to guide clinical decision-making or personal monitoring.
Clinical Evidence
No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, cut-off verification) and a lay-user study (n=420 per drug type). Lay-user study demonstrated high concordance with GC/MS results across various concentrations relative to cutoffs. Precision studies confirmed consistent performance across three lots and operators.
Technological Characteristics
Lateral flow immunochromatographic assay; monoclonal antibody-dye conjugate with gold chloride; fixed drug-protein conjugates on membrane. Formats: cassette, cup, dip card. No external energy source; visually read. Stable at 4-30°C for 24 months.
Indications for Use
Indicated for qualitative detection of Amphetamine, Benzoylecgonine, and Cannabinoids in human urine for over-the-counter and prescription use. Target populations include individuals requiring drug screening; no specific age or gender contraindications noted.
Regulatory Classification
Identification
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Special Controls
*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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
- First Check Multi Drug Cup 12 (K052115)
Related Devices
- K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) · Guangzhou Wondfo Biotech Co., Ltd. · Jun 27, 2016
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE
A. 510(k) Number:
K153646
B. Purpose for Submission:
New Device
C. Measurand:
Amphetamine (AMP)
Cocaine (COC)
Marijuana (THC)
D. Type of Test:
Qualitative Assay
E. Applicant:
Safecare BioTech Co., Ltd.
F. Proprietary and Established Names:
SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard)
SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard)
SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard)
G. Regulatory Information:
| Item | Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| SAFECARE Urine Test Amphetamine Cassette | LAF – Amphetamine | Class II | 862.3610 | 91-Toxicology |
| SAFECARE Urine Test Amphetamine Cup | LAF – Amphetamine | Class II | 862.3610 | 91-Toxicology |
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| Item | Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| SAFECARE Urine Test Amphetamine Dip Card | LAF – Amphetamine | Class II | 862.3610 | 91-Toxicology |
| SAFECARE Urine Test Cocaine Cassette | DIO – Cocaine | Class II | 862.3250 | 91-Toxicology |
| SAFECARE Urine Test Cocaine Cup | DIO – Cocaine | Class II | 862.3250 | 91-Toxicology |
| SAFECARE Urine Test Cocaine Dip Card | DIO – Cocaine | Class II | 862.3250 | 91-Toxicology |
| SAFECARE Urine Test Marijuana Cassette | LDJ – Marijuana | Class II | 862.3870 | 91-Toxicology |
| SAFECARE Urine Test Marijuana Cup | LDJ – Marijuana | Class II | 862.3870 | 91-Toxicology |
| SAFECARE Urine Test Marijuana Dip Card | LDJ – Marijuana | Class II | 862.3870 | 91-Toxicology |
H. Intended Use:
1. Intended use(s):
See indications for Use below.
2. Indication(s) for use:
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is
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positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
3. Special conditions for use statement(s):
For over-the-counter and prescription use
4. Special instrument requirements:
Not applicable. The devices are visually read and single-use.
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I. Device Description:
These devices are immunochromatographic assays for Amphetamine, Cocaine and Marijuana Urine Tests use a lateral flow, one step system for the qualitative detection of d-Amphetamine, Benzoylecgonine and 11-nor-Δ9-THC-9-COOH in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs, with gold chloride and fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibody in membranes.
The assays in this submission include a cassette, dip card, and cup formats. Each assay and format is available separately.
J. Substantial Equivalence Information:
1. Predicate device name(s): First Check Multi Drug Cup 12
2. Predicate 510(k) number(s): K052115
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate (K052115) |
| Intended Use | For the qualitative determination of AMP, COC, and THC in urine | The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is a screening test for the rapid detection of the twelve drugs listed above in human urine. |
| Calibrator Drug | D-amphetamine 11-nor-Δ⁹-THC-9 COOH Benzoylecgonine | D-amphetamine D-Methamphetamine Morphine Phenylcyclidine Oxazepam Secobarbital |
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate (K052115) |
| | | (+/-) Methadone
Nortriptyline
Oxicodone
(+/-)3,4-MDMA
11-nor-Δ⁹-THC-9 COOH
Benzoylecgonine |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL (COC)
1000 ng/mL (AMP)
50 ng/mL (THC) | Same |
| Intended Populations | For over-the-counter use | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Configurations | Cup, Dip Card, Cassette | Cup |
## K. Standard/Guidance Document Referenced (if applicable):
None were referenced
## L. Test Principle:
SAFECARE Urine Tests are tests for the qualitative detection of Benzoylecgonine, or D-amphetamine, or 11-nor-Δ⁹-THC-9 COOH in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample if sufficient volume of sample was applied.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +50% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days.
AMP Cassette
| AMP | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48/2+ | 25-/25+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
AMP Dip Card
| AMP | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
AMP Cup
| AMP | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
COC Cassette
| COC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 31-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 28-/22+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 28-/22+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
COC Dip Card
| COC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
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COC Cup
| COC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
THC Cassette
| THC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
THC Dip Card
| THC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
THC Cup
| THC | -100% cut off | -75% cut off | -50% cut off | -25% Cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 27-/23+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable, these devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
**Stability**
Real-time and accelerated stability studies were conducted on three lots of each device. The protocols for the stability studies were reviewed and found to be acceptable. The results of these studies indicated that all devices were found to be stable at $4 - 30^{\circ}\mathrm{C}$ (39-86°F) for 24 months based on the accelerated stability study at $50^{\circ}\mathrm{C}$ and a shelf life study at $30^{\circ}\mathrm{C}$. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
**Transportation Study**
A Transportation stability study was conducted on three lots of each device. The protocols for the transportation stability study were reviewed and found to be
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acceptable. The results of these studies indicated that all devices were found to be stable during transport of the device in temperatures between -20 and 50°C.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Compounds sharing structural or conformational similarity with the analytes were tested for cross-reactivity with the candidate device. The structurally related compounds that exhibited cross-reactivity with the candidate device were titrated to determine the percent cross-reactivity. The concentration (ng/mL) of cross-reactant that gives a response equivalent to the cutoff, and the percent cross-reactivity are presented in the table below.
Amphetamine Cross Reactivity
| Drugs | Concentration (ng/ml) | Reactivity |
| --- | --- | --- |
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 20000 | 5% |
| D,L - Amphetamine | 3000 | 33% |
| Phentermine | 30000 | 3% |
| Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine (MDA) | 20000 | 5% |
| d-Methamphetamine | Negative at 100000 | <1% |
| 1-Methamphetamine | Negative at 100000 | <1% |
| ephedrine | Negative at 100000 | <1% |
| Methylenedioxyethylamphetamine (MDE) | Negative at 100000 | <1% |
| 3,4-methylenedioxy-methamphetamine (MDMA) | Negative at 100000 | <1% |
Cocaine Cross Reactivity
| Drugs | Concentration (ng/ml) | Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine | 32000 | 0.9% |
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THC Cross Reactivity
| Drugs | Concentration (ng/ml) | Reactivity |
| --- | --- | --- |
| 11-Nor-Δ⁹-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 5000 | 1% |
| 11-Nor-Δ⁸-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| Cannabinol | 20000 | 0.3% |
| Δ⁸-Tetrahydrocannabinol | 10000 | 0.5% |
| Δ⁹-Tetrahydrocannabinol | 10000 | 0.5% |
| Cannabidiol | 20000 | 0.3% |
| 11-Nor-Δ⁹-THC-carboxy glucuronide | 2500 | 2% |
| (-)-11-nor-9-carboxy-Δ⁹-THC | 2500 | 2% |
# Interference Study
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs. These urine samples were tested using three batches of each device for all formats.
Compounds that showed no interference at a concentration of $100\mu \mathrm{g / mL}$ for different formats (cassette, cup, dipcard) are listed below:
| 4-Acetamidophenol | Chloralhydrate | Hydralazine | Papaverine |
| --- | --- | --- | --- |
| Acetophenetidin | Chloramphenicol | Hydrochlorothiazide | Penicillin-G |
| N-Acetylprocainamide | Chlordiazepoxide | Hydrocodone | Pentazocaine |
| Acetylsalicylic acid | Chlorothiazide | Hydrocortisone | Pentobarbital |
| Aminopyrine | (±)Chlorpheniramine | O-Hydroxyhippuric acid | Perphenazine |
| Amitryptyline | Chlorpromazine | 3-Hydroxytyramine | Phencyclidine |
| Amobarbital | Chlorquine | Ibuprofen | Phenelzine |
| Amoxicillin | Cholesterol | Imipramine | Phenobarbital |
| Ampicillin | Clomipramine | (-) Isoproterenol | Phetoin |
| Ascorbic acid | Clonidine | Isoxsuprine | L-Phenylephrine |
| Aspartame | Cocaine hydrochloride | Ketamine | Phenylpropanolamine |
| Atropine | Codeine | Ketoprofen | Prednisolone |
| Benzilic acid | Cortisone | Labetalol | Prednisone |
| Benzoic acid | (-) Cotinine | Levorphanol | Procaine |
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| Benzoylecgonine | Creatinine | Loperamide | Promazine |
| --- | --- | --- | --- |
| Bilirubin | Deoxycorticosterone | Maprotiline | Promethazine |
| Brompheniramine | Dextromethorphan | Meperidine | D,L-Propanolol |
| Caffeine | Diazepam | Meprobamate | D-Propoxyphene |
| Cannabidiol | Diclofenac | Methadone | Quinidine |
| Cannabinol | Diflunisal | Methylphenidate | Quinine |
| Trimethoprim | Digoxin | Morphine-3-Dglucuronide | Ranitidine |
| Trimipramine | Diphenhydramine | Nalidixic acid | Salicylic acid |
| Tryptamine | Doxylamine | Naloxone | Secobarbital |
| D, L-Tyrosine | Ecgonine hydrochloride | Naltrexone | Sulfamethazine |
| Uric acid | Ecgonine methylester | Naproxen | Sulindac |
| Verapamil | (IR,2S)-(-)-Ephedrine | Niacinamide | Temazepam |
| Zomepirac | L-Ephedrine | Nifedipine | Tetracycline |
| Gentisic acid | (-) Y Ephedrine | Norcodein | Tetrahydrocortisone |
| Hemoglobin | Erythromycin | Norethindrone | Tetrahydrozoline |
| Oxycodone | β-Estradiol | D-Norpropoxyphene | Δ9-THC-COOH |
| Oxymetazoline | Estrone-3-sulfate | Noscapine | Thebaine |
| Triamterene | Ethyl-p-aminobenzoate | D,L-Octopamine | Thiamine |
| Trifluoperazine | Fenfluramine | Oxalic acid | Thioridazine |
| | Fenoprofen | Oxazepam | D,L-Thyroxine |
| | Furosemide | Oxolinic acid | Tolbutamine |
## Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
## f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration is described in the precision section, M.1.a. above.
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2. Comparison studies:
a. Method comparison with predicate device:
The method comparison studies for the SAVECARE Urine Test (Amphetamine, Cocaine and Marijuana) were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results.
Amphetamine Cassette
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 1* | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
| Operator C | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
% agreement among positives is 96.7%
% agreement among negatives is 95.8%
* Samples contained AMP at 872, 903, and 920 ng/mL
† Samples contained AMP at 1025 and 1086 ng/mL
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13
# Cocaine Cassette
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
| Operator C | Positive | 0 | 0 | 1* | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2† | 0 |
% agreement among positives is 96.7%
% agreement among negatives is 95.8%
* Samples contained COC at 294 and 293 ng/mL
† Samples contained COC at 319 and 325 ng/mL
# THC Cassette
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2* | 0 |
| Operator B | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2* | 0 |
| Operator C | Positive | 0 | 0 | 2* | 17 | 20 |
| | Negative | 10 | 10 | 18 | 3* | 0 |
% agreement among positives is 94.2%
% agreement among negatives is 95%
* Samples contained THC at 46, 47, and 48 ng/mL
† Samples contained THC at 52 and 54 ng/mL
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14
# Amphetamine Cup
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
| Operator C | Positive | 0 | 0 | 1* | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1† | 0 |
% agreement among positives is 96.7%
% agreement among negatives is 95.8%
* Samples contained AMP at 872, 903, and 920 ng/mL
† Samples contained AMP at 1025, 1086, and 1129 ng/mL
# Cocaine Cup
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 1* | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2† | 0 |
| Operator B | Positive | 0 | 0 | 1* | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2† | 0 |
| Operator C | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
% agreement among positives is 95.8%
% agreement among negatives is 96.7%
* Samples contained COC at 294 and 293 ng/mL
† Samples contained COC at 319, 325, and 330 ng/mL
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THC Cup
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 3* | 17 | 20 |
| | Negative | 10 | 10 | 17 | 3† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
| Operator C | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
% agreement among positives is 94.2%
% agreement among negatives is 94.2%
* Samples contained THC at 44, 46, 47, and 48 ng/mL
† Samples contained THC at 52 and 54 ng/mL
Amphetamine Dip Card
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 1* | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
| Operator C | Positive | 0 | 0 | 1* | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2† | 0 |
% agreement among positives is 95.8%
% agreement among negatives is 96.7%
* Samples contained AMP at 903 and 920 ng/mL
† Samples contained AMP at 1025, 1086, and 1129 ng/mL
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16
# Cocaine Dip Card
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
| Operator B | Positive | 0 | 0 | 1* | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2† | 0 |
| Operator C | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
% agreement among positives is 95.8%
% agreement among negatives is 95.8%
* Samples contained COC at 288, 294, and 293 ng/mL
† Samples contained COC at 319, 325, and 330 ng/mL
# THC Dip Card
| Test | | Drug-free | Low Negative (<50% the cutoff conc) | Near Cutoff Negative (Between <50% below up to the cutoff conc) | Near Cutoff Positive (Between the cutoff and 50% above cutoff conc) | High Positive (>50% above the cutoff conc) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 2* | 19 | 20 |
| | Negative | 10 | 10 | 18 | 1† | 0 |
| Operator B | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
| Operator C | Positive | 0 | 0 | 2* | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2† | 0 |
% agreement among positives is 95.8%
% agreement among negatives is 95%
* Samples contained THC at 45, 46, 47, and 48 ng/mL
† Samples contained THC at 52 and 54 ng/mL
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b. Matrix comparison:
N/A
3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a. and b. are not applicable):
## Lay User Study
A lay user study was performed at three intended user sites with 420 lay persons testing the amphetamine devices, 420 lay persons testing the cocaine devices and 420 lay persons testing the marijuana devices. A total of 208 females and 212 males tested the amphetamine samples, 205 females and 215 males tested cocaine samples, and 212 females and 208 males tested the marijuana samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.5.
17
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AMP Cup
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1250 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
AMP Dip Card
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
18
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AMP Cassette
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
COC Cup
| % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
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COC Dip Card
| % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
COC Cassette
| % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 375 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
20
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THC Cup
| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62.5 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
THC Dip Card
| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 62.5 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
{21}
22
THC Cassette
| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 62.5 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
4. Clinical cut-off:
N/A
5. Expected values/Reference range:
N/A
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
