(266 days)
The Alkaline Phosphatase2 assay is used for the quantitation of alkaline phosphatase in human serum or plasma on the ARCHITECT c System.
Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The Alkaline Phosphatase2 assay is an automated clinical chemistry assay for the quantitation of alkaline phosphatase in human serum or plasma on the ARCHITECT c System. Alkaline Phosphatase in a sample catalyzes the hydrolysis of colorless para-nitrophenyl phosphate (p-NPP) to give para-nitrophenol (yellow phenoxide form at alkaline pH) and inorganic phosphate. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
The provided document is a 510(k) Premarket Notification for a clinical chemistry assay (Alkaline Phosphatase2) and does not describe an AI medical device. Therefore, the questions related to AI-specific acceptance criteria, ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.
The document focuses on the analytical performance of the Alkaline Phosphatase2 assay, demonstrating its substantial equivalence to a legally marketed predicate device. The information details various non-clinical performance studies to establish the device's reliability and accuracy for quantitating alkaline phosphatase in human serum or plasma.
Here's a breakdown of the relevant information from the document, tailored to the context of a diagnostic assay's performance evaluation, substituting the AI-specific questions with applicable details:
Acceptance Criteria and Device Performance for Alkaline Phosphatase2 Assay
This submission (K223317) is for a clinical chemistry assay, not an AI medical device. The acceptance criteria and performance studies are focused on the analytical performance of the assay to demonstrate its intended use for quantitative measurement of alkaline phosphatase.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" for regulatory review, but it details various performance studies with implicit acceptance ranges. The reported device performance metrics are presented instead.
Performance Metrics of Alkaline Phosphatase2 Assay (Representative Values)
| Performance Metric | Acceptance Criteria (Implied by Study Design & Clinical Standards) | Reported Device Performance (Example Values) |
|---|---|---|
| Analytical Measuring Interval (AMI) | Defined range for acceptable linearity, imprecision, and bias. | 4-4522 U/L |
| Reportable Interval | Extends from LoD to upper limit of AMI. | 3-4522 U/L |
| Precision (Within-Laboratory - %CV) | (Example target from CLSI EP05-A3 guidelines) | Range from 0.3% to 11.5% |
| * Low-End Control (~115 U/L)* | (e.g., |
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.