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K Number
K011599
Device Name
ALKALINE PHOSPHATASE LIQUID REAGENT
Manufacturer
JAS Diagnostics, Inc.
Date Cleared
2001-07-20

(57 days)

Product Code
CJE
Regulation Number
862.1050
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended for the In Vitro, quantitative determination of alkaline phosphatase in human serum on automated chemistry analyzers.

Alkaline phosphatase measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, which confirms that a medical device (JAS Alkaline Phosphatase Liquid Reagent) is substantially equivalent to existing devices. It does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you've requested.

Therefore, I cannot fulfill your request using the provided text. The document is essentially an approval letter, not a scientific study report.

§ 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.