(73 days)
The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.
The Roche COBAS INTEGRA Acetaminophen assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma. The COBAS INTEGRA Acetaminophen assay determinations are made on the COBAS INTEGRA 700 analyzer using an enzymatic reaction. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically. The change in absorbance is directly proportional to the quantitative drug concentration in serum. The COBAS INTEGRA 700 analyzer calculates the change in absorbance units (ΔΑ/min). After ΔΑ/min values have been calculated for the calibrators, the system calculates a best-fit curve for the calibrators using a linear least squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured AA/min value.
This document is a 510(k) summary for the Roche COBAS INTEGRA Acetaminophen assay, a device used for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on:
- Device Description: Explains the enzymatic reaction and colorimetric measurement used by the assay on the COBAS INTEGRA 700 analyzer.
- Regulatory Information: Specifies the submitter, device name, predicate device (COBAS INTEGRA Acetaminophen, K954992), and the FDA's clearance of the device.
- Indications for Use: Clearly states the intended use of the device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.