510(k) · Cleared

Cleared

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

K052101510(k) AbbreviatedCleared Aug 26, 200523-day reviewClass II21 CFR 864.8165

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics · KRZ Calibrator For Hemoglobin And Hematocrit Measurement

Cleared on Aug 26, 2005 as substantially equivalent to K934070 (Boehringer Mannheim Corp., 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Aug 26, 2005
Review: 23 days
Class: Class II
Product code: KRZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934070 (1994). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
This deviceK052101 C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005
Descendant · cites it directly · 4 of its ownK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK171771 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · Recalled
Descendant · 3 generations on · 0 of its ownK200256 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · Recalled
Descendant · 2 generations on · 0 of its ownK173206 SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc. · 2018
Descendant · cites it directly · 0 of its ownK142595 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit…Ortho Clinical Diagnostics · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all

K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · cites it directly4descendants
K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · 2 generations on1descendant
K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · 3 generations on0descendants
K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc. · 2018 · 2 generations on0descendants
K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934070	Tina-Quant Hemoglobin A1C	Boehringer Mannheim Corp.	1994	—
0 (this device)	K052101	C.F.a.S. (Calibrator for Automated Systems) HBA1C	Roche Diagnostics	2005	—
+1	K130255	Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls	Abbott Laboratories	2014	3
+2	K171771	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay	Siemens Healthcare Diagnostics, Inc.	2017	1
+3	K200256	ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay	Siemens Healthcare Diagnostics, Inc.	2021	2
+2	K173206	SEKURE HbA1c Assay	Sekisui Diagnostics P.E.I., Inc.	2018	—
+1	K142595	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS…	Ortho Clinical Diagnostics	2015	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	2	0
2017	1	0
2018	1	0
2021	1	0

FIG. 1 — Lineage of K052101, 1994–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K934070	Tina-Quant Hemoglobin A1C Summary page 1 …ue sheet. Predicate We claim substantial equivalence to the calibrator included in the Tina-Quant device HbA I c reagent kit, originally cleared under K934070. C.f.a.s. HbAlc is identical to this calibrator; however, it is now being provided at a single…	Boehringer Mannheim Corp.	1994	—

Also cleared against K934070: 5 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130255	Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls	Abbott Laboratories	2014	4
K142595	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…	Ortho Clinical Diagnostics	2015	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K130255 (Abbott Laboratories, 2014) has gone furthest, with 4 descendants of its own.
5 other devices also cite its predicate K934070.

How does its category compare?

All KRZ devices

KRZ Calibrator For Hemoglobin And Hematocrit Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRZ

FDA has decided no KRZ device since 2007.

Median 510(k) review, days · KRZ

Too few KRZ 510(k)s in any year since 2007 to give a median.

Recalls per year · KRZ

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRZ

1in 2022

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code KRZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	1	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	2
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052101: C.F.a.S. (Calibrator for Automated Systems) HBA1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052101

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026