(153 days)
The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine in urine at a cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
The ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzoylecgonine in a urine sample. The test is based on the principle of antigenantibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of cocaine and its metabolite (Benzoylecgonine) in urine at a cutoff concentration of 150 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Benzoylecgonine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text regarding the ACON COC-150 One Step Cocaine Test Strip and Test Device, structured according to your request:
Acceptance Criteria and Study for ACON COC-150 One Step Cocaine Test
The document describes a clinical evaluation to demonstrate the substantial equivalence of the ACON COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device. The primary acceptance criteria appear to be high agreement rates (ideally 100% or very close with tight confidence intervals) when compared to both a predicate FDA-cleared cocaine test and Gas Chromatography/Mass Spectrometry (GC/MS) analysis at specified concentration ranges.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (vs. FDA-cleared Cocaine Test) | Reported Device Performance (vs. GC/MS at Cutoff) - ACON Test Strip | Reported Device Performance (vs. GC/MS at Cutoff) - ACON Test Device |
|---|---|---|---|
| High Positive Agreement | 100% (97.4% - 100% CI) | 98.6% (95.0% - 99.8%) CI for Positive samples > Cutoff | 98.6% (95.0% - 99.8%) CI for Positive samples > Cutoff |
| High Negative Agreement | 100% (97.7% - 100% CI) | 98.7% (95.5% - 99.6%) CI for Negative samples 95% agreement"). Instead, it presents the results, implying that the achieved performance, particularly the 100% agreement with the predicate device and very high agreement with GC/MS, met the necessary standards for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 300 clinical urine specimens.
- Approximately 10% of these specimens contained Benzoylecgonine concentrations that fell within -25% cutoff to +25% cutoff range, indicating a focus on the critical decision point around the cutoff.
- Data Provenance: The document states "clinical urine specimens," implying human-derived samples. However, it does not specify the country of origin of the data. It also does not explicitly state if the data was retrospective or prospective. Given it's a "clinical evaluation," it's likely prospective collection of samples or retrospective use of stored clinical samples, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not specify the number of experts used and their qualifications for establishing ground truth.
- The ground truth for the comparison was established by an "FDA-cleared cocaine test" and "customary Gas Chromatography/Mass Spectrometry analysis." These are analytical methods, not human experts making subjective diagnoses.
4. Adjudication Method for the Test Set
- None in the context of human expert adjudication. The ground truth was established by laboratory methods (predicate device and GC/MS), which are objective and do not require adjudication in the way subjective human assessments would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study was NOT done. This study focuses on the performance of the device itself against established methods, not on how human readers perform with or without AI assistance. The device is a "rapid chromatographic immunoassay" that provides a visual, qualitative end result, and is not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study was done. The entire evaluation described is a standalone performance assessment of the ACON COC-150 test strip and device. It measures the device's ability to detect Benzoylecgonine in urine specimens independently, without human interpretation influencing the result beyond the visual reading of a line (which is inherent to the device's design). The comparison against GC/MS is a direct measure of its standalone analytical performance.
7. The Type of Ground Truth Used
- The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is considered the "gold standard" confirmatory method for drug testing and provides highly accurate quantitative data, from which qualitative "positive" or "negative" results are derived based on the 150 ng/mL cutoff.
- Additionally, an FDA-cleared predicate device was used for comparative purposes, serving as a secondary ground truth reference.
8. The Sample Size for the Training Set
- The document does not mention a training set sample size. This is expected because the ACON COC-150 devices are immunoassays, not machine learning or AI algorithms that require a separate training phase. The manufacturing process and quality control for these devices ensure their performance.
9. How the Ground Truth for the Training Set Was Established
- As no training set is described or implied for this type of immunoassay device, the question of how its ground truth was established is not applicable.
§ 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).