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K Number
K033847
Device Name
A1CNOW FOR HOME AND PROFESSIONAL USE
Manufacturer
METRIKA, INC.
Date Cleared
2003-12-23

(12 days)

Product Code
LCP
Regulation Number
864.7470
Type
Special
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AlcNow® test provides quantitative measurement of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Metrika, Inc A1cNow® device, a glycated hemoglobin assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, and study design.

Therefore, I cannot provide the requested information based on the provided text.

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).