510(k) Report

510(k) · Cleared

Recalled · 2009

Variant II Hemoglobin A1C Program

K984268510(k) TraditionalCleared Dec 17, 199817-day reviewClass II21 CFR 864.7470Recalls 2

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

Bio-Rad · LCP Assay, Glycosylated Hemoglobin

Cleared on Dec 17, 1998 as substantially equivalent to K926469 (Bio-Rad, 1993) after a 17-day review. Its family tree reaches back 1 generation to 1993. 21 later devices descend from it. It has been recalled 2 times.

Decided
Dec 17, 1998
Review
17 days
Class
Class II
Product code
LCP
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K926469 (1993). 21 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2006: 3 descendants cleared2001: 1 descendant cleared2009: 2 descendants cleared2013: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant clearedK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 19931990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant K926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 19930
  1. Root · 1 generation backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
  2. This deviceK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998
  3. Descendant · cites it directly · 11 of its ownK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  5. Descendant · cites it directly · 3 of its ownK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK090699 Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set…Bio-Rad Laboratories, Inc. · 2009
  7. Descendant · 2 generations on · 2 of its ownK063400 Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System…Bio-Rad Laboratories, Inc. · 2006 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2001: 12003: 12004: 22006: 32007: 22009: 22011: 12012: 12013: 22014: 12015: 12019: 12024: 12025: 12026: 1
2001high 3 (2006) · low 0 (2002)2026

Most influential descendants

Showing 5 of 21 · See all
  • K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · cites it directly11descendants
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015 · 2 generations on4descendants
  • K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · cites it directly3descendants
  • K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc. · 2009 · 2 generations on2descendants
  • K063400Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Bio-Rad Laboratories, Inc. · 2006 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926469Variant (TM) Hemoglobin a 1C ProgramBio-Rad1993—
0 (this device)K984268Variant II Hemoglobin A1C ProgramBio-Rad1998—
+1K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc.20071
+2K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.2015—
+1K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc.20044
+2K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models…Bio-Rad Laboratories, Inc.2009—
+2K063400Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Bio-Rad Laboratories, Inc.20064

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200420
200630
200720
200920
201110
201210
201320
201410
201510
201910
202410
202510
202610
FIG. 1 — Lineage of K984268, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K926469Variant (TM) Hemoglobin a 1C Program
Summary page 1
…eparation: November 23, 1998 Device Name: VARIANT™ II HbAlc Program Classification Name: Assay, Glycosylated Hemoglobin, 81 LCP Predicate Device: VARIANT™ HbA1c Program K926469 Bio-Rad Laboratories Hercules, CA 94547 Statement of Intended Use: The VARIANT™ II Hemoglobin A, Program is intended for the d…
Bio-Rad1993—

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc.200711
K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc.20043
K031043D-10 Hemoglobin A1CBio-Rad Laboratories, Inc.20032
K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi20061
K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc.20041
K012410Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc.20010

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 22, 2009Not classifiedZ-1902-2010Software designSample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
Jan 22, 2009Not classifiedZ-1901-2010Software designSample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K070452 (Bio-Rad Laboratories, Inc., 2007) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 VARIANT™ II Hemoglobin A, Program is intended for the determination of hemoglobin A in human whole blood using ion-exchange high performance liquid chromatography (HPLC).

The VARIANT™ II Hemoglobin A, Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System.

For in vitro diagnostic use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bio-Rad

322 FDA decisions under this applicant name. See the company

  • K171061MRSASelect IIBio-Rad · 20171 recall
  • K122187Vreselect Culture MediumBio-Rad · 2012
  • K103684Vreselect Culture MediumBio-Rad · 2011
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
  • K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010

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/K984268 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984268: Variant II Hemoglobin A1C Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984268

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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