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The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The COBAS INTEGRA ONLINE DAT II Cocaine II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drugpolymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody . Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

The provided text is a 510(k) summary for the Roche COBAS INTEGRA ONLINE DAT II Cocaine II assay. It details the device, its intended use, and its comparison to a predicate device. However, it does not include any section describing acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided document.

To answer your request, I would need a section from the 510(k) submission that details:

• Performance characteristics studies (e.g., accuracy, precision, sensitivity, specificity, interference)
• The acceptance criteria set for these performance characteristics
• The results of the studies showing how the device met those criteria.

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