(145 days)
The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:
THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
OPI Morphine 300 ng/ml
MET Methamphetamine 500 ng/ml
AMP Amphetamine 1000 ng/ml
PCP Phencyclidine 25 ng/ml
BZO Oxazepam 300 ng/ml
BAR Secobarbital 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
OXY Oxycodone 100 ng/ml
BUP Buprenorphine 10 ng/ml
PPX Propoxyphene 300 ng/ml
These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.
These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fasted® II Drug Screen Dipstick or Fasted® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.
The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.
The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
The provided document describes the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices, which are lateral flow immunoassays for the qualitative detection of Propoxyphene (PPX) and other drugs in human urine at specified cutoff concentrations.
1. Table of Acceptance Criteria and Reported Device Performance (Focus on Propoxyphene as it's the new analyte):
The document does not explicitly state "acceptance criteria" through numerical thresholds for sensitivity, specificity, or accuracy in a traditional sense. Instead, the acceptance criterion for regulatory approval appears to be demonstrating substantial equivalency to a predicate device (ACON® multi-CLINTM Drug Screen Test Device K041685) for the detection of Propoxyphene at a 300 ng/ml cutoff. The "Performance Specifications" section outlines the types of analytical studies conducted to establish this equivalency.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Summary from Conclusion) |
|---|---|---|
| Functional Equivalence | Detect Propoxyphene in human urine. | All devices mentioned (Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, QuickTox® Drug Screen Dipcard) detect Propoxyphene. |
| Cut-off Concentration | Detect Propoxyphene at or above 300 ng/ml. | All devices are standardized to detect Propoxyphene at a cutoff concentration of 300 ng/ml. |
| Test Principle | Utilize competitive immunoassay. | All devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and utilize a competitive immunoassay procedure. |
| Analytical Performance | Demonstrate performance comparable to predicate for: | Conclusion: "The performance characteristics studies performed demonstrate substantial equivalency between the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, QuickTox® Drug Screen Dipcard and the predicate kit ACON™ Drug Screen test device with the same cutoff concentration of 300 ng/ml." Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in this summary, but the studies listed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) were conducted to support this conclusion. |
| - Stability | ||
| - Optimal Read Time | ||
| - Precision | ||
| - Method Comparison | ||
| - Specificity and Interference | ||
| - Effect of pH and Specific Gravity | ||
| Safety and Effectiveness | Safe and effective for qualitative detection of Propoxyphene. | "We have demonstrated that the Fasted II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard are safe and effective for the qualitative detection of Propoxyphene at a cutoff concentration of 300ng/ml." |
2. Sample Size Used for the Test Set and Data Provenance:
The document lists the types of performance characteristic studies performed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) but does not provide details on the sample sizes used for these test sets.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For drug screening tests like these, ground truth is typically established through a reference method (like GC/MS or LC/MS), not through a panel of experts interpreting results.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. When a reference method like GC/MS is used to establish ground truth, there isn't typically an "adjudication method" involving multiple human readers interpreting the output of the reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study evaluates the performance of human readers, sometimes with and without AI assistance. The described devices are in vitro diagnostic tests that provide a visual qualitative result, intended for direct use by a professional without a complex interpretation process that would typically involve multiple readers. The document highlights the need for confirmation by GC/MS or LC/MS for preliminary positive results, indicating that human interpretation of the dipstick is a preliminary step, not a diagnostic endpoint requiring complex reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance studies described are essentially standalone performance evaluations. The devices are immunochromatographic tests that yield a visual result (presence or absence of a line). The "performance characteristics studies" (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) evaluate the inherent analytical performance of the device itself, independent of human interpretation variability after the preliminary visual reading. The device's "algorithm" is the biochemical reaction and the visual readout mechanism.
7. The Type of Ground Truth Used:
The document states: "All preliminary positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis." This strongly implies that Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be the gold standard or "ground truth" used to validate the performance of these devices in a method comparison study. These are highly sensitive and specific analytical techniques for drug detection and quantification.
8. The Sample Size for the Training Set:
This information is not provided as these are not machine learning/AI devices in the traditional sense that require a "training set." The development of such immunoassay devices involves laboratory testing and optimization of reagents, antibodies, and manufacturing processes, rather than training on a dataset in the way an AI algorithm would be trained.
9. How the Ground Truth for the Training Set Was Established:
As these are not traditional AI devices with a "training set," this question is not directly applicable. The "ground truth" for optimizing the assay's performance during development would rely on known concentrations of propoxyphene and its metabolites, confirmed by highly accurate analytical methods like GC/MS or LC/MS.
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).