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K Number
K070734
Device Name
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2007-04-09

(24 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

Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Diazyme Direct Enzymatic HbA1c Assay, stating that the device is substantially equivalent to a legally marketed predicate device.

The information provided focuses on:

  • The FDA's review and determination of substantial equivalence.
  • Regulatory classification of the device.
  • General controls provisions and other regulations the manufacturer must comply with.
  • Contact information for further inquiries.
  • The intended use of the device ("Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control.").

None of the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment are present in this document.

§ 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).