(27 days)
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
Here's a breakdown of the acceptance criteria and study information for the HiChem ALP/AMP Reagent, based on the provided text:
Important Note: The provided document is a 510(k) summary for a diagnostic reagent, not a medical device in the typical sense of AI-powered imaging or diagnostic software. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to existing, legally marketed devices through analytical performance characteristics.
Acceptance Criteria and Reported Device Performance
Device: HiChem ALP/AMP Reagent (product no. 70001)
Intended Use: Quantitative determination of alkaline phosphatase (ALP) in serum and plasma.
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Manual Procedure | ||
| Linearity (30°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), r² = 0.9998, sy.x = 6.5 U/L |
| Linearity (37°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), r² = 0.9998, sy.x = 8.0 U/L |
| Precision (37°C) | Replicate assay with acceptable within-run and total SD values (implied by tabulated results) | See table below for detailed precision results at 37°C (n=30 for each control). |
| Comparison to MAS ALP Reagent | Acceptable correlation and agreement (implied by regression statistics) | r² = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results), sy.x = 5.5 U/L |
| Anticoagulant Interference | Bias |
§ 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.