# K092911: Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model DZ168B-Con, Smart HBAC1C Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Apr 26, 2010 after 216 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K111664: Diazyme Cystatin C Poc Test Kit (2012), 0 descendants of its own

## Indications for use
SMART Hemoglobin Alc (Glycated hemoglobin Alc; Alc; HbAlc) Assay Reagent Kit is intended for use with the SMART analyzer for the quantitative determination of stable H-bAic in human capillary and venous whole blood samples. Measurement of hemoglobin Alc is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only. SMART HbAlIc Assay Controls are intended for use as quality controls for the SMART HbAlIc Assay reagents. For in vitro diagnostic use only. SMART analyzer is a compact cuvette based spectrophotometei machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbAlc reagent kit and SMART HbAlc Assay Controls, is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K092911
Methodology: https://510kreport.com/methodology