# K160762: Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Nov 21, 2016 after 245 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070734 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070734: Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal, DZ168A-Con, Diazyme Laboratories (2007) Summary page 13.

## Indications for use
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis) test kit is intended for use in the quantitative determination of stable HbA1c in venous whole blood samples with on-board blood lysis application in a clinical laboratory. This test is not to be used to diagnose or screen for diabetes. The measurement of HbA1c concentration is for use in monitoring long-term glucose control of persons with diabetes. For in-vitro diagnostic use only. Diazyme Direct HbA1c Assay Calibrator Set is intended to be used for calibration of Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis). For in-vitro diagnostic use only. Diazyme Direct HbA1c Assay Control Set is intended to be used for quality control by monitoring accuracy and precision of Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis). For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K160762
Methodology: https://510kreport.com/methodology