(392 days)
QuickScreen™ Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't typically contain detailed "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it presents performance data to show the new device performs similarly to the predicate device and is safe and effective for its intended use. The "acceptance criteria" can be inferred from the reported performance meeting the generally understood expectations for such devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that explicit formal acceptance criteria are not stated in the document, I will infer them based on the context of drug screening tests and the data presented. The primary acceptance criteria for a qualitative drug screening test revolve around its ability to accurately identify positive and negative samples relative to a confirmatory method, especially around the cutoff concentration.
Device: QuickScreen Drug Screening Test System (specifically for Amphetamine 500 ng/ml cutoff)
| Performance Metric (Inferred Acceptance Criterion) | Reported Device Performance (Amphetamine 500 ng/ml) |
|---|---|
| Sensitivity / Precision (Qualitative Agreement around Cutoff): | |
| Accurately identify negative samples below cutoff. | |
| Accurately identify positive samples above cutoff. | Negative samples: |
| All samples at 100.86 ng/ml, 211.2 ng/ml, 286.22 ng/ml tested negative (60/60 for multi-card, cassette, cup; 80/80 for dipcard at 100.86 ng/ml; 60/60 for dipcard at other concentrations). | |
| Positive samples: | |
| All samples at 583.3 ng/ml, 878 ng/ml, 1062 ng/ml, 1361 ng/ml tested positive (60/60 for all formats and concentrations). | |
| Method Comparison (Clinical Sample Agreement with GC/MS): | |
| High concordance with GC/MS for both positive and negative samples, particularly near the cutoff. | |
| Minimize false positives and false negatives. | Overall Agreement: |
| For samples above cutoff, the device correctly identified all as positive (22 samples in "Cutoff to +50%" and 20 in "High Positive" categories for all formats). | |
| For samples below cutoff, the device correctly identified all as negative (23 samples in "Negative: NO DRUG" and 19 in "Negative |
§ 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).