510(k) Report

510(k) · Cleared

Recalled · 2008

Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program

K063643510(k) SpecialCleared Dec 27, 200620-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., Clinical Systems Divisi · LCP Assay, Glycosylated Hemoglobin

Cleared on Dec 27, 2006 as substantially equivalent to K984268 (Bio-Rad, 1998) and 2 other predicates after a 20-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it. It has been recalled once.

Decided
Dec 27, 2006
Review
20 days
Class
Class II
Product code
LCP
Recalls
1
Predicates
3

Its longest line of descent runs back 2 generations to K926469 (1993). 5 ancestors in all, the oldest K924122 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1993: 1 other ancestor2013: 1 descendant clearedK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 1993K984268 · Variant II Hemoglobin A1C Program · Bio-Rad · 1998 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation 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 deviceK063643 Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006
  4. Descendant · cites it directly · 0 of its ownK130860 Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013 · cites it directly0descendants
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)K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short…Bio-Rad Laboratories Inc., Clinical Systems Divisi2006—
+1K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System…Bio-Rad Laboratories, Inc., Clinical Systems Divis2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K063643, 1993–2013Source: 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? (3)

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
…es: VARIANTTm II Hemoglobin Al c Program Bio-Rad Laboratories, Inc. [K984268, December 17, 1998]] VARIANTTM II Beta thalassemia Short Program…
Bio-Rad19982
*K991127Variant II B-Thalassemia
Summary page 1
…VARIANTTM II Beta thalassemia Short Program Bio-Rad Laboratories, Inc. [K991127, June 10, 1999]] VARIANT TM II Total GHb Program…
Bio-Rad19994
*K003280Variant II Total GHB
Summary page 1
…VARIANT TM II Total GHb Program Bio-Rad Laboratories, Inc. [K003280, December 19, 2000] Bio-Rad Laboratories, Inc 4-A- I Intended Use: This software submissi…
Bio-Rad2000—

Also cleared against K984268: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 9, 2008Not classifiedZ-1395-2009PendingThe wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K130860 (Bio-Rad Laboratories, Inc., Clinical Systems Divis, 2013) has gone furthest, with 0 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.

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?

Hemoglobin A1c The Bio-Rad VARIANT II Hemoglobin A1c Program with CDM 4.0 is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin A1c Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Total GHb The VARIANT II Total GHb Program with CDM 4.0 is intended…

Read the full statement (226 words)

Hemoglobin A1c

The Bio-Rad VARIANT II Hemoglobin A1c Program with CDM 4.0 is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

The Bio-Rad VARIANT II Hemoglobin A1c Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.

Total GHb

The VARIANT II Total GHb Program with CDM 4.0 is intended for the separation and area percent determination of total glycated hemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).

The VARIANT II Total GHb Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.

Measurement of percent hemoglobin A1 C is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Beta-thalassemia

The VARIANT II Beta-thalassemia Short Program with CDM 4.0 is intended for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography.

The VARIANT II Beta-thalassemia Short Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.

Measurement of percent HbA2 and HbF are used for evaluation of Beta-thalassemia, a hereditary hemolytic anemia.

Indications for use as stated in the FDA summary.

Also cleared against K984268

5 other devices cite the same predicate.

  • K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 20071 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., Clinical…

3 FDA decisions under this applicant name. See the company

  • K080911Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008
  • K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 20075 recalls

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/K063643 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063643

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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