SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Device Facts
| Record ID | K182654 |
|---|---|
| Device Name | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card |
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd. |
| Product Code | NGG · Clinical Toxicology |
| Decision Date | Nov 19, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamine, Phencyclidine, Methadone, Nortriotyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunichromatographic assays for qualitative and simultaneous detection of Amphetanine, Oxazepam, Methamphetamine, Morghine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of SAFECARE® Multi-Drug Urine Test Cup contination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine. Oxazenam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
Device Story
Single-use in vitro diagnostic devices (Dip Card or Cup formats) for qualitative detection of drugs of abuse in human urine. Operates via competitive binding, lateral flow immunochromatographic assay; urine sample migrates via capillary action. If target drug concentration is below cutoff, specific monoclonal mouse antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence. Used by lay users in home/OTC settings. Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Provides rapid screening to assist in identifying potential drug use.
Clinical Evidence
No clinical diagnostic studies performed. Evidence consists of analytical performance (precision, interference, cross-reactivity) and a lay user study (n=300 per format). Lay user study demonstrated high concordance with LC/MS confirmed samples across various concentrations relative to cutoff levels.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use, visually read. No instrumentation required. Components include test device, package insert, and urine collection cup. Sealed in aluminum pouch with desiccant.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, MDMA, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphene) in human urine. Intended for over-the-counter use. Not for distinguishing between prescription use and abuse.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
Related Devices
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · May 27, 2020
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Jul 26, 2018
- K182530 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 9, 2018
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k182654
B. Purpose for Submission:
Modification of a previously cleared device to add 6 new drug test strips.
C. Measurand:
Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Hangzhou Safecare Biotech Co., Ltd
F. Proprietary and Established Names:
SAFECARE Multi-Drug Urine Test Dip Card; SAFECARE Multi-Drug Urine Test Cup
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| NFW Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| NGG Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGI Morphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) |
| NFV Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
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| NGL
Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| --- | --- | --- | --- |
| PTH
Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| NGL
Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NGG
Methylenedioxy-methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGM
Phencyclidine | unclassified | Enzyme Immunoassay
Phencyclidine | Toxicology (91) |
| PTG
Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
| QAW
Nortriptyline | II | 21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System | Toxicology (91) |
| QBF
Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) |
## H. Intended Use:
1. Intended use(s):
Refer to Indications for Use below.
2. Indication(s) for use:
SAFECARE Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
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Methadone 300 ng/mL
Nortriptyline 1000 ng/mL
d-Propoxyphene 300 ng/mL
Configuration of SAFECARE Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
SAFECARE Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of SAFECARE Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain
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a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
3. Special conditions for use statement(s):
For over the counter use.
4. Special instrument requirements:
Not applicable. The devices are visually read and single-use.
I. Device Description:
The SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene (target analytes) in human urine. The devices are single-use in vitro diagnostic devices. SAFECARE Multi-Drug Urine Test Dip Card comes in the dip card format, and SAFECARE Multi-Drug Urine Test Cup comes in the cup format. Each test kit contains a device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Chemtrue Multi-Panel Drug Screen Dip Card Tests
2. Predicate 510(k) number(s):
k142396
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device (k142396) |
| Intended Use | Same | For the qualitative determination of drugs of abuse in human urine. |
| Analytes and cutoffs | Same | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 300 ng/ml
11-Nor-Δ9-Tetrahydrocannabinol-9-COOH |
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| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device (k142396) |
| | | (THC):50 ng/ml |
| | | Methamphetamine (MET): 1,000 ng/ml |
| | | Morphine (OPI): 2000ng/ml |
| | | Secobarbital (BAR): 300 ng/ml |
| | | Methadone (MTD): 300 ng/ml |
| | | Methylenedioxy-methamphetamine (MDMA): 500 ng/ml |
| | | Oxycodone (OXY): 100 ng/ml |
| | | Buprenorphine (BUP): 10 ng/ml |
| | | Phencyclidine (PCP): 25 ng/ml |
| | | Nortriptyline (TCA): 1000 ng/ml |
| | | Propoxyphene (PPX): 300 ng/ml |
| Methodology | Same | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. |
| Intended Users | Same | Over the counter |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device (k142396) |
| Configurations | Dipcard and Cup | Dipcard, cup, and cassette |
## K. Standard/Guidance Document Referenced (if applicable):
None referenced
## L. Test Principle:
The SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present
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in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Please refer to k181968 for precision data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone.
Methylenedioxy-methamphetamine – Dip Card
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methylenedioxy-methamphetamine – Cup
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Oxycodone – Dip Card
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxycodone – Cup
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0 | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0 | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0 | 50+/0- | 50+/0- | 50+/0- |
Buprenorphine – Dip Card
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Buprenorphine – Cup
| Results
Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Phencyclidine – Dip Card
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Phencyclidine – Cup
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Nortriptyline – Dip Card
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Nortriptyline – Cup
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Propoxyphene – Dip Card
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- |
Propoxyphene – Cup
| Lot Number | Results | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable; these devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
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.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Interferences
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine with concentrations at 25% below and 25% above the cutoff levels for each analyte. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100 µg/mL, for either the SAFECARE Multi-Drug Urine Test Dip Card or the SAFECARE Multi-Drug Urine Test Cup, are listed in the following tables.
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| Acetominophen (4-Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
| --- | --- | --- |
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5-Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
10
{10}
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| --- | --- | --- |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Cholesterol | Loperamide | Tetrahydrozoline |
| Clonidine | Maprotiline | Thiamine |
| Cortisone | Meperidine | Thioridazine |
| (-) Cotinine | Meprobamate | Triamterene |
| Creatinine | Methoxyphenamine | DL-Tyrosine |
| Deoxycorticosterone | Nalidixic acid | Trifluoperazine |
| Dextromethorphan | Naloxone | Trimethoprim |
| Diclofenac | Naltrexone | D L-Tryptophan |
| Diflunisal | Naproxen | Tyramine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nifedipine | Verapamil |
| Disopyramide | Norethindrone | Zomepirac |
| EDDP | Noscapine | |
11
{11}
12
# Cross-reactivity
To evaluate cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were tested using three lots of each device. The lowest concentrations of tested compounds that caused a positive result for each compound are listed below for Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Cross-reactivity data was reported in k181968 for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone. There were no differences in cross-reactivity observed between the SAFECARE Multi-Drug Urine Test Dip Card or the SAFECARE Multi-Drug Urine Test Cup.
| Compound | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Methylenedioxy-methamphetamine | 500 | 100% |
| 3,4-Methylenedioxyamphetamine | 5000 | 10% |
| 3,4-Methylenedioxyethylamphetamine | 300 | 166% |
| d-methamphetamine | >100000 | <1% |
| d-amphetamine | >100000 | <1% |
| l-amphetamine | >100000 | <1% |
| l-methamphetamine | >100000 | <1% |
| Compound | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Oxymorphone | 250 | 40% |
| Hydrocodone | 3125 | 3.2% |
| Dihydrocodeine | >100000 | <0.1% |
| Codeine | >100000 | <0.1% |
| Hydromorphone | >100000 | <0.1% |
| Morphine | >100000 | <0.1% |
| Buprenorphine | >100000 | <0.1% |
| Ethylmorphine | >100000 | <0.1% |
| Compound | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Buprenorphine | 10 | 100% |
| Buprenorphine -3-D-Glucuronide | 10 | 100% |
| Norbuprenorphine | 50 | 20% |
| Norbuprenorphine-3-D-Glucuronide | 100 | 10% |
| Morphine | >100000 | <0.01% |
| Oxymorphone | >100000 | <0.01% |
| Hydromorphone | >100000 | <0.01% |
| Compound | Result Positive at(ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 75 | 33% |
{12}
| Compound | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Nortriptyline | 1000 | 100% |
| Amitriptyline | 750 | 133.30% |
| Clomipramine | 10000 | 10% |
| Desipramine | 200 | 500% |
| Doxepin | 1250 | 80% |
| Imipramine | 625 | 160% |
| Maprotiline | 2000 | 50% |
| Nordoxepin | 1000 | 100% |
| Promazine | 1500 | 66.70% |
| Promethazine | 25000 | 4% |
| Trimipramine | 3000 | 33.30% |
| Cyclobenzaprine Hydrochloride | 5000 | 20% |
| Norclomipramine | 3000 | 33.30% |
| Compound | Result Positive at(ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| d-Propoxyphene | 300 | 100% |
| D-Norpropoxyphene | 330 | 91% |
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity and urine samples with pH 4 to 9 were spiked with the target analytes at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results for the pH and specific gravity samples 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 between the SAFECARE Multi-Drug Urine Test Dip Card or the SAFECARE Multi-Drug Urine Test Cup.
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.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies for the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup were performed with three laboratory assistants performing the tests for each device format. The operators analyzed 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Methylenedioxy-methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene. Method comparison results were reported in k181968 for Amphetamine, Oxazepam, Cocaine, Marijuana,
{13}
Methamphetamine, Morphine, Secobarbital and Methadone.
Methylenedioxy-methamphetamine
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM1822 | 491 | Positive |
| Viewer B | AM5121 | 497 | Positive |
| Viewer C | AM1822 | 491 | Positive |
| Viewer C | AM5121 | 497 | Positive |
| Viewer A | AM2281 | 517 | Negative |
| Viewer A | AM3339 | 509 | Negative |
| Viewer B | AM2281 | 517 | Negative |
| Viewer B | AM6217 | 525 | Negative |
| Viewer C | AM6217 | 525 | Negative |
| Viewer C | AM3339 | 509 | Negative |
{14}
Methylenedioxy-methamphetamine
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 10 | 18 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM5135 | 491 | Positive |
| Viewer A | AM6745 | 497 | Positive |
| Viewer B | AM5135 | 491 | Positive |
| Viewer C | AM5135 | 491 | Positive |
| Viewer C | AM6745 | 497 | Positive |
| Viewer A | AM8048 | 517 | Negative |
| Viewer A | AM4472 | 509 | Negative |
| Viewer B | AM4472 | 509 | Negative |
| Viewer B | AM4835 | 525 | Negative |
| Viewer C | AM8048 | 517 | Negative |
| Viewer C | AM4472 | 509 | Negative |
15
{15}
16
Oxycodone
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 10 | 19 | 3 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM8592 | 95 | Positive |
| Viewer B | AM3867 | 98 | Positive |
| Viewer C | AM7495 | 92 | Positive |
| Viewer A | AM1177 | 104 | Negative |
| Viewer A | AM3128 | 107 | Negative |
| Viewer B | AM9817 | 106 | Negative |
| Viewer B | AM9785 | 109 | Negative |
| Viewer C | AM0928 | 108 | Negative |
| Viewer C | AM1177 | 104 | Negative |
| Viewer C | AM3128 | 107 | Negative |
{16}
17
Oxycodone
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 10 | 19 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 10 | 19 | 3 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM0623 | 98 | Positive |
| Viewer B | AM5357 | 95 | Positive |
| Viewer C | AM0623 | 98 | Positive |
| Viewer A | AM7016 | 105 | Negative |
| Viewer A | AM3335 | 106 | Negative |
| Viewer B | AM7525 | 104 | Negative |
| Viewer B | AM0654 | 107 | Negative |
| Viewer B | AM3335 | 106 | Negative |
| Viewer C | AM7016 | 105 | Negative |
| Viewer C | AM7525 | 104 | Negative |
| Viewer C | AM3335 | 106 | Negative |
{17}
Buprenorphine
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM7493 | 9 | Positive |
| Viewer B | AM1093 | 9 | Positive |
| Viewer C | AM1093 | 9 | Positive |
| Viewer A | AM6936 | 11 | Negative |
| Viewer A | AM0902 | 11 | Negative |
| Viewer B | AM6497 | 11 | Negative |
| Viewer B | AM0902 | 11 | Negative |
| Viewer C | AM6936 | 11 | Negative |
{18}
Buprenorphine
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM8338 | 9 | Positive |
| Viewer B | AM4130 | 9 | Positive |
| Viewer C | AM4130 | 9 | Positive |
| Viewer A | AM3059 | 11 | Negative |
| Viewer A | AM5605 | 11 | Negative |
| Viewer B | AM5605 | 11 | Negative |
| Viewer B | AM2763 | 11 | Negative |
| Viewer C | AM3059 | 11 | Negative |
| Viewer C | AM2763 | 11 | Negative |
{19}
Phencyclidine
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM1553 | 23 | Positive |
| Viewer B | AM1159 | 24 | Positive |
| Viewer C | AM1159 | 24 | Positive |
| Viewer A | AM2982 | 25.3 | Negative |
| Viewer B | AM5901 | 26 | Negative |
| Viewer B | AM2982 | 25.3 | Negative |
| Viewer C | AM2982 | 25.3 | Negative |
{20}
Phencyclidine
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM7467 | 24 | Positive |
| Viewer B | AM6637 | 23 | Positive |
| Viewer C | AM7467 | 24 | Positive |
| Viewer A | AM1449 | 26 | Negative |
| Viewer A | AM8727 | 25.3 | Negative |
| Viewer B | AM8727 | 25.3 | Negative |
| Viewer C | AM1449 | 26 | Negative |
| Viewer C | AM8727 | 25.3 | Negative |
{21}
22
# Nortriptyline
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM9403 | 982 | Positive |
| Viewer B | AM2316 | 998 | Positive |
| Viewer C | AM9403 | 982 | Positive |
| Viewer A | AM7812 | 1004 | Negative |
| Viewer A | AM0170 | 1031 | Negative |
| Viewer B | AM4373 | 1023 | Negative |
| Viewer B | AM0170 | 1031 | Negative |
| Viewer C | AM7812 | 1004 | Negative |
| Viewer C | AM4373 | 1023 | Negative |
{22}
23
# Nortriptyline
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM0528 | 998 | Positive |
| Viewer B | AM0528 | 998 | Positive |
| Viewer C | AM0528 | 998 | Positive |
| Viewer A | AM6084 | 1004 | Negative |
| Viewer A | AM6157 | 1031 | Negative |
| Viewer B | AM6084 | 1004 | Negative |
| Viewer B | AM9869 | 1023 | Negative |
| Viewer C | AM9869 | 1023 | Negative |
| Viewer C | AM6157 | 1031 | Negative |
{23}
Propoxyphene
| Dip Card | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 17 | 20 |
| | Negative | 10 | 10 | 20 | 3 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer |
| --- | --- | --- | --- |
| Viewer A | AM9748 | 294 | Positive |
| Viewer B | AM8770 | 290 | Positive |
| Viewer A | AM6660 | 315 | Negative |
| Viewer A | AM8794 | 306 | Negative |
| Viewer B | AM6660 | 315 | Negative |
| Viewer B | AM2236 | 309 | Negative |
| Viewer C | AM6660 | 315 | Negative |
| Viewer C | AM8794 | 306 | Negative |
| Viewer C | AM2236 | 309 | Negative |
{24}
25
Propoxyphene
| Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 17 | 20 |
| | Negative | 10 | 10 | 19 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AM7095 | 290 | Positive |
| Viewer B | AM1226 | 294 | Positive |
| Viewer C | AM7095 | 290 | Positive |
| Viewer A | AM9825 | 306 | Negative |
| Viewer A | AM6247 | 309 | Negative |
| Viewer B | AM8797 | 315 | Negative |
| Viewer B | AM9825 | 306 | Negative |
| Viewer B | AM6247 | 309 | Negative |
| Viewer C | AM8797 | 315 | Negative |
| Viewer C | AM6247 | 309 | Negative |
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
{25}
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 300 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 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 LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, one blind labeled sample and a device. Each device was tested. Results are shown below.
SAFECARE Multi-Drug Urine Test Cup
Amphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 505 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 754 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1259 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
Cocaine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 152 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 373 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
{26}
Marijuana
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 25 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 37 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87 | 20 | 0 | 100 |
Secobarbital
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 226 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 372 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 529 | 20 | 0 | 100 |
Oxazepam
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |
27
{27}
Methamphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 251 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 502 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 758 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1259 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1512 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
Methadone
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 376 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
Morphine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 505 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 1009 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 1510 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 2511 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 3031 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 3521 | 20 | 0 | 100 |
28
{28}
Methylenedioxy-methamphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 123 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 248 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 376 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 622 | 17 | 3 | 85 |
| +50% Cutoff | 40 | 741 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 871 | 20 | 0 | 100 |
Oxycodone
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 49 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 75 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 124 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 149 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100 |
Buprenorphine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 3 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 5 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 8 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 13 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 15 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 18 | 20 | 0 | 100 |
29
{29}
Phencyclidine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 6 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 13 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 19 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 31 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 38 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100 |
Nortriptyline
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 252 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 499 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 759 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1258 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1503 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1751 | 20 | 0 | 100 |
Propoxyphene
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 77 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 374 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |
30
{30}
SAFECARE Multi-Drug Urine Test Dip Card
Amphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 505 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 754 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1259 | 17 | 3 | 85 |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
Cocaine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 152 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 373 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
Marijuana
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 25 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 37 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87 | 20 | 0 | 100 |
{31}
Secobarbital
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 226 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 372 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 529 | 20 | 0 | 100 |
Oxazepam
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 376 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |
Methamphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 251 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 502 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 758 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1259 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1501 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
32
{32}
Methadone
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
Morphine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 505 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 1009 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 1510 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 2511 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 3005 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 3521 | 20 | 0 | 100 |
Methylenedioxy-methamphetamine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 123 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 248 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 376 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 622 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 741 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 871 | 20 | 0 | 100 |
33
{33}
Oxycodone
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 49 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 75 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 124 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 149 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100 |
Buprenorphine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 3 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 5 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 8 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 13 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 15 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 18 | 20 | 0 | 100 |
Phencyclidine
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 6 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 13 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 19 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 31 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 38 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100 |
34
{34}
35
# Nortriptyline
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 252 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 499 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 759 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1258 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1503 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1751 | 20 | 0 | 100 |
# Propoxyphene
| % of Cutoff | Number of samples | Drug Concentration by LC/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 | 77 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 149 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 523 | 20 | 0 | 100 |
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
