(114 days)
For in vitro diagnostic use only. VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolites) in human urine using a cutoff of either a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose.
The VITROS Chemistry Products COCM assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
The VITROS COCM assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products COCM Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5.1 FS Chemistry Systems.
The VITROS COCM Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzoylecgonine (cocaine metabolite) in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to benzoylecgonine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing benzoylecgonine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzoylecgonine in the treated urine sample and benzoylecgonine labeled with the enzyme glucose-6-phosphate dchydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzoylecgonine in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD+) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
The VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. The VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). These calibrators are used in combination to calibrate VITROS 5.1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzoylecgonine (cocaine metabolites) in urine.
The VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V are prepared from a human urine pool to which analytes. surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS COCM assay on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) is a common reagent that is used by multiple assays on the VITROS 5,1 FS Chemistry System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry mstrament that provieds and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
The provided text describes the 510(k) summary for the VITROS Chemistry Products COCM Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V. It details their intended uses and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, performance metrics, or detailed study results for the new device as typically found in a clinical study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, or ground truth for test sets.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size for the training set or how ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to predicate devices based on similarities in indications for use, test principle, cutoff values, specimen type, reagent format, antibody source, and calibrator properties. It mentions "correlation studies" and "bench testing... to determine assay precision, linearity, specificity, expected values, limit of detection, dilution, stability, and specimen matrix," but does not provide the results of these studies or the criteria used to evaluate them.
The closest the document comes to performance claims are the statements:
- "The results demonstrated good agreement between the two immunoassay methods." (referring to the comparison between the VITROS COCM assay and the Syva® Emit® II Plus Cocaine Metabolite assay).
- "The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products COCM Reagent... are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices."
- "Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples."
Without explicit performance data and acceptance criteria, a detailed table and description of the study as requested cannot be generated from the given 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).