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K Number
K994045
Device Name
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
Manufacturer
PRIMUS CORP.
Date Cleared
1999-12-21

(22 days)

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

In vitro diagnostic use to establish reference points for glycated hemoglobin test methods

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for "Primus Liquid Calibrators for GHb/A1c Level 1 and Level 2." While it confirms the device is substantially equivalent to a predicate, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information from the given input. The document is solely an FDA clearance letter and does not detail the technical study data or acceptance criteria used for approval.

§ 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).