510(k) Report

510(k) · Cleared

Recalled · 2009

Variant II Hemoglobin A1C Program with Models 270-2101NU

K070452510(k) TraditionalCleared May 7, 200780-day reviewClass II21 CFR 864.7470Recalls 1

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

Bio-Rad Laboratories, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on May 7, 2007 as substantially equivalent to K984268 (Bio-Rad, 1998) after an 80-day review. Its family tree reaches back 2 generations to 1993. 11 later devices descend from it. It has been recalled once.

Decided
May 7, 2007
Review
80 days
Class
Class II
Product code
LCP
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K926469 (1993). 11 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2015: 1 descendant cleared2009: 2 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant clearedK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 1993K984268 · Variant II Hemoglobin A1C Program · Bio-Rad · 1998 · recalled1990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K984268 · Variant II Hemoglobin A1C Program · Bio-Rad · 1998 · recalledK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 19930
  1. Root · 2 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
  2. 1 generation backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
  3. This deviceK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007
  4. Descendant · cites it directly · 4 of its ownK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  5. Descendant · cites it directly · 2 of its ownK090699 Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set…Bio-Rad Laboratories, Inc. · 2009
  6. Descendant · 2 generations on · 1 of its ownK122472 Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2012
  7. Descendant · 2 generations on · 0 of its ownK252749 Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026
  8. Descendant · 2 generations on · 0 of its ownK242911 Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2009: 22011: 12012: 12013: 22015: 12019: 12024: 12025: 12026: 1
2009high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015 · cites it directly4descendants
  • K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc. · 2009 · cites it directly2descendants
  • K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis · 2012 · 2 generations on1descendant
  • K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
  • K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K926469Variant (TM) Hemoglobin a 1C ProgramBio-Rad1993—
−1K984268Variant II Hemoglobin A1C ProgramBio-Rad19982
0 (this device)K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc.2007—
+1K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.2015—
+1K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models…Bio-Rad Laboratories, Inc.2009—
+2K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis2012—
+2K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.2026—
+2K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201110
201210
201320
201510
201910
202410
202510
202610
FIG. 1 — Lineage of K070452, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Top candidate predicates for a new LCP device

  1. #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K984268Variant II Hemoglobin A1C Program
Summary page 1
…Name: Assay, Glycosylated Hemoglobin, 81LCP Predicate Device: VARIANTTM II Hemoglobin AIc Program K984268 Bio-Rad Laboratories, Inc. (Catalog number 270-2101) I…
Bio-Rad19982

Also cleared against K984268: 5 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.20154
K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc.20092
K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130
K102510Dimensions HB1C Kit, Model DF105ASiemens Healthcare Diagnostics20110
K090737Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection…Bio-Rad Laboratories, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 15, 2009Not classifiedZ-1013-2010OtherCalibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K151321 (Bio-Rad Laboratories, Inc., 2015) has gone furthest, with 4 descendants of its own.
  • 5 other devices also cite its predicate K984268.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LCP

1in 2024

2007: 72008: 52009: 62010: 22011: 102012: 92013: 22014: 82015: 32016: 22017: 52018: 22019: 42020: 12023: 22024: 1
2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007: 133 days median2008: 206 days median2009: 158 days median2011: 176 days median2012: 143 days median2014: 127 days median2015: 239 days median2017: 218 days median2019: 269 days median
2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007: 12008: 32009: 62010: 52011: 512013: 42014: 22015: 22016: 62017: 12018: 12022: 12024: 12025: 1
2007high 51 (2011) · low 0 (2012)2026

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

Adverse event reports per year · LCP

22in 2025

2007: 52008: 112009: 152010: 42011: 272012: 512013: 1932014: 1822015: 642016: 292017: 1492018: 1,9112019: 1142020: 132021: 72022: 82023: 272024: 392025: 22
2007high 1,911 (2018) · low 4 (2010)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007713315
20085206311
20096158615
20102—54
2011101765127
20129143051
20132—4193
201481272182
20153239264
20162—629
201752181149
20182—11,911
201942690114
20201—013
20210—07
20220—18
20232—027
20241—139
20250—122
20260—0—

What is it indicated for?

The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for Professional Use Only.

Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Indications for use as stated in the FDA summary.

Also cleared against K984268

5 other devices cite the same predicate.

  • K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB ProgramBio-Rad Laboratories Inc., Clinical Systems Divisi · 20061 recall
  • K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. · 20042 recalls
  • K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 20044 recalls
  • K031043D-10 Hemoglobin A1CBio-Rad Laboratories, Inc. · 20036 recalls
  • K012410Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc. · 2001

More from Bio-Rad Laboratories, Inc.

103 FDA decisions under this applicant name. See the company

  • K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 20191 recall
  • K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. · 2017
  • K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. · 2016
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  • K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015

Recent decisions in LCP

The LCP category page

  • K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K231465Q-Pad Test SystemQurasense · 2023
  • K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
  • K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd. · 2019

https://510kreport.com/device/K070452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070452

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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