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K Number
K063209
Device Name
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
Manufacturer
THERMO ELECTRON OY
Date Cleared
2007-03-21

(149 days)

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

The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "HbA1c Test System, Calibrator, Control normal, and Control abnormal." It primarily discusses the regulatory approval process and does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, most of the requested information cannot be extracted from this document as it focuses on regulatory clearance rather than a detailed technical performance study.

Here's what can be inferred or stated based on the provided text:

  • Device Name: HbA1c Test System, HbA1c Calibrators, HbA1c Control Normal, HbA1c Control Abnormal
  • Intended Use: Quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
  • Regulatory Status: Substantially equivalent to legally marketed predicate devices, Class II.

Regarding the specific questions about acceptance criteria and study details:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document. This type of information would typically be in the 510(k) submission itself (which is not this letter) and would detail performance metrics like accuracy, precision, linearity, and analytical measurement range, along with the criteria for acceptable performance (e.g., %CV

§ 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).