(230 days)
Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 ag/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test:
Based on the provided 510(k) Summary and the FDA clearance letter, the device is a qualitative immunoassay for detecting benzoylecgonine in human urine. The information presented describes performance characteristics and comparisons rather than explicitly stated "acceptance criteria" presented as pass/fail thresholds. However, we can infer the performance metrics considered acceptable based on the reported results.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device | (Implied: High correlation, demonstrating substantial equivalence) The statement "higher than 94.6 %" suggests that a correlation in this range was considered acceptable for demonstrating equivalence to a legally marketed device. | 94.6% |
| Agreement across POL sites | (Implied: High agreement across different user environments) The 94.2% agreement suggests that maintaining consistency in results when used by diverse personnel in various settings (Physician's Office Laboratories, POL) was an important consideration. | 94.2% agreement across three POL sites |
| Accuracy (vs. expected results/ground truth) | (Implied: High accuracy against established reference or expected results). The 97.8% agreement figure suggests that a high level of accuracy when compared to a reference method or expected outcome was necessary to demonstrate the device's reliability. The phrasing "agreed 97.8% with the results expected" implies a comparison to a gold standard or a highly reliable method. | 97.8% agreement with expected results in Clinical Laboratory and three Physician's Offices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for the test set used in the performance studies. It mentions:
- "The correlation of results from the Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test, and the legally marketed test device compared, is higher than 94.6 %." (This implies a comparison study with an unspecified number of samples.)
- "The results from the three POL sites agreed 94.2%." (This indicates data collected from three Physician's Office Laboratories, but not the number of samples.)
- "The Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 97.8 % with the results expected." (This indicates data from a clinical lab and three POLs, but no sample count.)
Data Provenance: The studies were conducted in a "Clinical Laboratory" and "three Physician's Offices (POL sites)." This suggests the data was collected likely within the United States, given the context of a 510(k) submission to the FDA. The studies appear to be prospective in nature, as they involve testing the device and comparing its performance to predicate devices or expected results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The text refers to "results expected" and comparison with a "legally marketed test device," implying a reference method was used, but details on the experts or their qualifications for establishing ground truth are absent. Given it's a diagnostic test for a substance, the "expected results" would likely be derived from a more definitive analytical method, such as GC/MS if used as a reference.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It describes agreement percentages between the device and a predicate, or expected results, and agreement across POL sites, but not a process for resolving discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study, specifically for comparing human readers with and without AI assistance, is not relevant or described for this device. This is a qualitative immunoassay for substance detection, not an image-based AI diagnostic tool requiring human interpretation comparison. The "diverse educational backgrounds and working experience" of personnel in the POLs suggests a multi-user evaluation, but not an MRMC study in the context of AI-assisted human reading.
6. Standalone Performance Study
Yes, a standalone performance evaluation of the algorithm (device) was done. The entire document describes the performance of the "Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test" itself. The reported correlations and accuracy percentages (94.6%, 94.2%, 97.8%) are measures of the device's performance in detecting benzoylecgonine.
7. Type of Ground Truth Used
The ground truth or reference standard appears to be based on:
- Comparison with a predicate device: "legally marketed test device compared" (QuikStrip One Step Cocaine Test, K971926).
- "Results expected": This strongly implies a comparison against a more definitive method or a known concentration of benzoylecgonine in urine samples. The "Indications For Use" also explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method." This suggests that GC/MS or a similar high-precision analytical method would be the ultimate ground truth for establishing the "expected results."
8. Sample Size for the Training Set
The document does not mention a training set. This type of immunoassay device typically does not involve machine learning algorithms that require a "training set" in the conventional sense. Its performance is based on the inherent biochemical properties of the antibodies and reagents used.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of ground truth for such a set is not applicable and not described.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).