(271 days)
One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:
Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml.
Cocaine (COC) Benzoylecgonine 300 ng/ml.
Amphetamine (AMP) D-Amphetamine 1000 ng/ml.
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 ne/ml.
The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.
These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
The provided document describes the performance of the Co-Innovation Biotech Co., Ltd. One Step Single/Multi-drug Test Cup and Dipcard for the qualitative detection of drugs and drug metabolites in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance metrics (like sensitivity, specificity, or agreement percentages). Instead, it presents the results of clinical studies (accuracy studies) designed to demonstrate the device's performance against a gold standard (GC/MS). The implied acceptance is that the device demonstrates a high level of agreement with GC/MS, especially near and above the cutoff concentrations.
For the purpose of this response, I infer the performance target is to achieve high agreement with GC/MS. The reported device performance is shown in the tables below, demonstrating the number of positive and negative results from the device compared to GC/MS at different concentration levels.
Performance Summary (based on provided data for both formats: Cup and Dipcard)
| Drug Test | Cut-off Level (ng/mL) | Device Format | Agreement with Drug Free (Negative Result) | Agreement with
§ 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).