# K052101: C.F.a.S. (Calibrator for Automated Systems) HBA1C

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics
- Decided: Aug 26, 2005 after 23 days
- Product code: KRZ (Calibrator For Hemoglobin And Hematocrit Measurement)
- Device class: 2
- Regulation: 21 CFR 864.8165
- 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 K934070 (1994). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934070: Tina-Quant Hemoglobin A1C, Boehringer Mannheim Corp. (1994) Summary page 1.

## Most influential descendants
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls (2014), 4 descendants of its own
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (2017), 1 descendant of its own
- K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (2021), 0 descendants of its own
- K173206: SEKURE HbA1c Assay (2018), 0 descendants of its own
- K142595: VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (2015), 0 descendants of its own

## Indications for use
C.f.a.s. (Calibrator for automated systems) HbAlc is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K052101
Methodology: https://510kreport.com/methodology