(66 days)
Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The ONLINE DAT II Cocaine II assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission.
The provided text is a 510(k) Summary for the Roche Diagnostics ONLINE DAT II Cocaine II assay. This document describes an in vitro diagnostic test and establishes its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be presented to prove a device meets specific acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is missing from the 510(k) summary.
Here's what I can extract based on the available information, along with what is explicitly missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The 510(k) summary does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or a performance table. It describes the device and its intended use, then compares it generally to a predicate device, but does not present the results of a validation study against predefined criteria.
2. Sample size used for the test set and the data provenance:
- Missing. The document does not mention any specific test set, sample sizes, or data provenance (country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing. Since no specific test set or study results are detailed, there is no information on expert involvement for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. Adjudication methods are not discussed as no test set details are provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Missing. The device described is an in vitro diagnostic assay (a chemical test), not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study in the typical sense of imaging or clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. This is a standalone in vitro diagnostic assay. Its performance would be evaluated as "algorithm only" (i.e., the assay's chemical reaction and detection system) without human intervention in the result generation itself (though human intervention is required for sample collection and operating the analyzer). However, the specific performance metrics and studies are not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Likely reference methodology or spiked samples, but not explicitly stated. For an immunoassay detecting a specific metabolite, ground truth would typically be established using:
- Confirmatory quantitative methods (e.g., GC/MS or LC/MS) on urine samples.
- Urine samples spiked with known concentrations of the analyte.
- The document does not state how ground truth was established for any performance evaluation.
8. The sample size for the training set:
- Not applicable / Missing. For an immunoassay, there isn't a "training set" in the machine learning sense. The assay's "training" refers to its development and optimization based on chemical principles, antibody-antigen binding, and reaction kinetics. However, data would be collected during development to optimize parameters and establish cutoff values. This specific sample size is not mentioned.
9. How the ground truth for the training set was established:
- Not applicable / Missing. (See point 8).
Summary of what is available:
- Device Name: ONLINE DAT II Cocaine II
- Intended Use: Qualitative and semi-quantitative detection of benzoylecgonine (cocaine metabolite) in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Also permits assessment of assay performance as part of a quality control program.
- Predicate Device: Abuscreen OnLine Cocaine Metabolite assay (K983697)
- Principle of Procedure: Kinetic Interaction of Microparticles in a Solution (KIMS) – an immunoassay where drug-polymer conjugates bind to antibody-bound microparticles, causing aggregation. In the presence of sample drug, this aggregation is inhibited. Absorbance changes are measured.
- Key Differences from Predicate:
- Use of a benzoylecgonine monoclonal antibody (mouse) attached to microparticles.
- A soluble drug-polymer conjugate.
- Addition of a 150 ng/ml cutoff concentration.
- Use of new calibrators and unassayed controls.
To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to refer to the full 510(k) submission or an associated scientific publication or device manual, which are not included in the provided text.
§ 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).