(28 days)
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine and PCP OR Methamphetamine in urine. The QuickScreen Pro Multi Drug Drug Screening Test, like many commercially available drug screening test kits, qualitatively measures of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical "acceptance criteria" are not explicitly stated in a formalized table within the document, the performance metrics achieved by the device serve as the de-facto acceptance benchmarks for substantial equivalence. The document primarily focuses on correlation and overall accuracy.
| Performance Metric | Reported Device Performance | Acceptance Criteria (Implied) |
|---|---|---|
| Correlation to Behring EMIT II and GC/MS | >98% correlation | Likely >95% (based on "substantially equivalent") |
| Overall Accuracy (professional users) | >97% overall accuracy | Likely >95% (based on "excellent overall accuracy") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical sample correlation study" and "blind labeled spiked study" but does not provide the number of samples used in these studies.
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated, though a "clinical sample correlation study" usually implies prospective collection of clinical samples. "Blind labeled spiked study" would involve prospectively prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The study involved "professional users" in clinical settings, but their specific qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The study evaluated the device's performance against reference methods and in the hands of professional users, but not in a head-to-head comparison with human readers, or how it improves human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the studies described (correlation with GC/MS and EMIT II, and overall accuracy) appear to demonstrate the standalone performance of the device. The device itself is a qualitative immunoassay, and its performance is assessed directly.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Reference Laboratory Methods: The primary ground truth for the correlation study was established using the Behring EMIT II (an established immunoassay) and GC/MS (Gas Chromatography/Mass Spectrometry) methodology. GC/MS is considered a gold standard for drug detection and quantification in forensic and clinical toxicology.
- Clinical Specimen Results: For the "overall accuracy" study, the ground truth would have been derived from the reference methods applied to the clinical specimens.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an immunoassay (a biochemical test), not a machine learning algorithm that requires a "training set" in the conventional sense. Its performance is inherent to its biochemical design.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as it's not a machine learning algorithm requiring a training set. The device's design and manufacturing processes would be based on established immunological principles and verified through analytical validation.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).