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K Number
K992921
Device Name
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
Manufacturer
PRIMUS CORP.
Date Cleared
1999-11-12

(74 days)

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

Evaluate glycated hemoglobin test accuracy In vitro diagnostic use only

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, indicating the clearance of a device. It does not contain information about the acceptance criteria, device performance, study design, or any of the specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document is a legal notification of substantial equivalence, not a summary of a clinical or performance study. Therefore, I cannot extract the requested information from this 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).