510(k) Report

510(k) · Cleared

Cleared

Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software

K130860510(k) SpecialCleared Apr 25, 201328-day reviewClass II21 CFR 864.7470

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 Divis · LCP Assay, Glycosylated Hemoglobin

Cleared on Apr 25, 2013 as substantially equivalent to K070452 (Bio-Rad Laboratories, Inc., 2007) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1993.

Decided
Apr 25, 2013
Review
28 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K926469 (1993). 7 ancestors in all, the oldest K924122 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1993: 1 other ancestorK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 1993K984268 · Variant II Hemoglobin A1C Program · Bio-Rad · 1998 · recalledK063643 · Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program · Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor K063643 · Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program · Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · recalledK984268 · Variant II Hemoglobin A1C Program · Bio-Rad · 1998 · recalledK926469 · Variant (TM) Hemoglobin a 1C Program · Bio-Rad · 19930
  1. Root · 3 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
  2. 2 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
  3. 1 generation backK063643 Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · Recalled
  4. This deviceK130860 Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K926469Variant (TM) Hemoglobin a 1C ProgramBio-Rad1993—
−2K984268Variant II Hemoglobin A1C ProgramBio-Rad19982
−1K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short…Bio-Rad Laboratories Inc., Clinical Systems Divisi20061
0 (this device)K130860Variant 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
200710
FIG. 1 — Lineage of K130860, 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? (2)

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
*K070452Variant II Hemoglobin A1C Program with Models 270-2101NU
Summary page 1
…duct Regulation and INumber Code VARIANT 11Hemoglobin Ale Program K070452 21 CFR 864.7470 (LCP) VARIANT 110-thalassemia Short Program K063643 21 CFR 864.7400 (JPD) Int…
Bio-Rad Laboratories, Inc.20071
*K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…
Summary page 1
…Code VARIANT 11Hemoglobin Ale Program K070452 21 CFR 864.7470 (LCP) VARIANT 110-thalassemia Short Program K063643 21 CFR 864.7400 (JPD) Intended and Intended Use: VARIANT 11 Hemoglobin Alc Program Indications for Use…
Bio-Rad Laboratories Inc., Clinical Systems Divisi20061

Also cleared against K070452: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K070452.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 VARIANTTM 11 Hemoglobin Alic Program is intended for the percent determination of hemoglobin Alic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Aic Program is intended for Professional Use Only. For in vitro diagnostic usge. Measurement of percent hemoglobin Alic is effective in monitoring long-term glucose control in individuals with diabetes mnellitus. The VARIANTrm…

Read the full statement (155 words)

The Bio-Rad VARIANTTM 11 Hemoglobin Alic Program is intended for the percent determination of hemoglobin Alic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Aic Program is intended for Professional Use Only. For in vitro diagnostic usge.

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

The VARIANTrm II (-thalassemia Short Program 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 (HPLC). The Bio-Rad VARIANT II P-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT 11 Hemoglobin Testing System. For in vitro diagnostic use.

Measurement of the percent hemoglobin A2 and F are effective in screening of(- thalassemnia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains)

Indications for use as stated in the FDA summary.

Also cleared against K070452

4 other devices cite the same predicate.

  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  • K102510Dimensions HB1C Kit, Model DF105ASiemens Healthcare Diagnostics · 20111 recall
  • K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc. · 2009
  • K090737Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5…Bio-Rad Laboratories, Inc. · 2009

More from Bio-Rad Laboratories, Inc., Clinical…

3 FDA decisions under this applicant name. See the company

  • K130990Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
  • K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis · 2012

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/K130860 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130860: Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130860

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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