(58 days)
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Syntron's QuikStrip One Step Amphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Here's a breakdown of the acceptance criteria and study details for the QuikStrip One Step Amphetamine Test, based on the provided 510(k) submission:
Acceptance Criteria and Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Clinical Trial) |
|---|---|---|
| Relative Sensitivity (Agreement within positive samples) | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
| Relative Specificity (Agreement within negative samples) | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
| Accuracy | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
Note: The document phrasing "yielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples of 1.00 and an accuracy of 100%" for in-house testing, and "a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100%" for the clinical trial, strongly suggests these high percentages were the de facto acceptance criteria.
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size:
- In-house testing: Not explicitly stated, but performed against samples "documented to be positive by GC/MS."
- Clinical Trial: 308 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Syntron Bioresearch, Inc. in Carlsbad, California, implying the study was likely conducted in the USA.
- Retrospective or Prospective: Not explicitly stated. Given the context of a 510(k) submission for an existing product type and comparison to a predicate device, it's possible it was retrospective, using archived samples or newly collected samples for the purpose of the submission.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable/not specified. The ground truth was established by laboratory methods (GC/MS and EMIT II®), not by human experts interpreting results.
- Qualifications of Experts: N/A.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. Results were compared against a reference method (EMIT II®) and a confirmatory method (GC/MS). Discrepancies were resolved by GC/MS.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is an in-vitro diagnostic (IVD) test where the result is read directly from the test strip (presence/absence of a color band). Human reader variability is not a primary concern for its performance evaluation in this context. The study focuses on comparing the device's output to other analytical methods.
6. Standalone Performance Study
- Was a standalone study done? Yes. The entire study describes the standalone performance of the QuikStrip One Step Amphetamine Test by comparing its results directly to established reference methods (EMIT II® and GC/MS) without human readers interpreting its output in combination with other information.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Primary Comparison: Syva EMIT® II (Enzyme Multiplied Immunoassay Technique), which is itself a screening assay.
- Confirmatory Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). All positive samples by either screening method (QuikStrip or EMIT II®) that were used to determine the true positive/negative status were confirmed by GC/MS. This is considered a gold standard for drug detection.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. As a lateral flow immunoassay, the device itself is not a machine learning algorithm that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical and biological formulation and manufacturing process, which would have been refined during development. The provided document only details the validation (test set) performance.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. For traditional IVDs, the "ground truth" during development involves iterative testing and refinement against known positive and negative samples, often using methods like GC/MS to characterize those samples. However, the specific details for the "training set" are not provided in this 510(k) summary.
§ 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).