(49 days)
ACE® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.
ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer.
The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD' to NADH.
Here's an analysis of the provided text regarding the ACE® Phenobarbital Reagent, detailing its acceptance criteria and the study that proves its performance:
ACE® Phenobarbital Reagent: Acceptance Criteria and Performance Study
The ACE® Phenobarbital Reagent is an enzyme immunoassay intended for the quantitative determination of phenobarbital in human serum. This 510(k) premarket notification (K973536) demonstrates substantial equivalence to a predicate device, the DRI Phenobarbital Enzyme Immunoassay (K946210).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and standard performance metrics for such assays. The reported performance of the Proposed Device (ACE® Phenobarbital Reagent) is compared against that of the Predicate Device for substantial equivalence.
| Parameter | Acceptance Criteria (Implied from Predicate) | Reported Proposed Device Performance |
|---|---|---|
| Assay Range | 0.5 µg/mL to 80 µg/mL | 1.3 µg/mL to 80 µg/mL |
| Precision | ||
| Consistency |
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.