(30 days)
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. 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. 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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. 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.
The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
The provided text describes the performance characteristics of the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. The document details analytical performance (precision, linearity, stability, interference, specificity, effect of specific gravity and pH) and comparison studies (method comparison and lay-user study).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each analytical performance characteristic are implicitly defined by the successful results reported in the study. The study aims to demonstrate that the device performs as expected according to its intended use and analytical specifications.
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Precision:
- Acceptance Criteria for -100% to -25% Cut-off: All samples should test negative.
- Acceptance Criteria for +25% to +100% Cut-off: All samples should test positive.
- Acceptance Criteria for Cut-off (nominal concentration): Approximately 50% positive and 50% negative results (reflecting the nature of the cut-off).
- Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
- Dip Card (Lot 1, 2, 3):
- -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
- +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
- Cut-off: 24-/26+, 25-/25+, 26-/24+ (Split between positive and negative, as expected)
- Cup (Lot 1, 2, 3):
- -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
- +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
- Cut-off: 27-/23+, 24-/26+, 26-/24+ (Split between positive and negative, as expected)
- Dip Card (Lot 1, 2, 3):
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Interference:
- Acceptance Criteria: No interference from common physiological or pathological substances at specified concentrations.
- Reported Device Performance: No interference observed for a comprehensive list of compounds at 100ug/mL (except albumin at 100mg/dL and ethanol at 1% volume).
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Specificity (Cross-Reactivity):
- Acceptance Criteria: Related compounds should either not cross-react or cross-react at concentrations significantly higher than the cut-off, as defined by medical relevance.
- Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
- Methadone: Positive at 300000 ng/mL (0.1% cross-reactivity)
- EMDP: Positive at 300000 ng/mL (0.1% cross-reactivity)
- Doxylamine, Disopyramide, LAAM HCl, Alpha Methadol: Positive at >100,000 ng/mL (
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).