510(k) Report

510(k) · Cleared

Cleared

Variant (TM) Hemoglobin a 1C Program

K926469510(k) TraditionalCleared Mar 29, 199391-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 · LCP Assay, Glycosylated Hemoglobin

Cleared on Mar 29, 1993 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it.

Decided
Mar 29, 1993
Review
91 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
0

22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 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 cleared1990200020102020
  1. This deviceK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
  2. Descendant · cites it directly · 21 of its ownK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 4 of its ownK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  5. Descendant · 2 generations on · 3 of its ownK040872 Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK090699 Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set…Bio-Rad Laboratories, Inc. · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12003: 12004: 22006: 32007: 22009: 22011: 12012: 12013: 22014: 12015: 12019: 12024: 12025: 12026: 1
1998high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 22 · See all
  • K984268Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · cites it directly21descendants
  • K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · 2 generations on11descendants
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015 · 3 generations on4descendants
  • K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc. · 2004 · 2 generations on3descendants
  • K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730Bio-Rad Laboratories, Inc. · 2009 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926469Variant (TM) Hemoglobin a 1C ProgramBio-Rad1993—
+1K984268Variant II Hemoglobin A1C ProgramBio-Rad19982
+2K070452Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc.20071
+3K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.2015—
+2K040872Variant II Hemoglobin A1CBio-Rad Laboratories, Inc.20044
+3K090699Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models…Bio-Rad Laboratories, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200310
200420
200630
200720
200920
201110
201210
201320
201410
201510
201910
202410
202510
202610
FIG. 1 — Lineage of K926469, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K984268Variant II Hemoglobin A1C ProgramBio-Rad199821

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?

  • Of its descendants, K984268 (Bio-Rad, 1998) has gone furthest, with 21 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—

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https://510kreport.com/device/K926469 · printed Nov 4, 2026

Cite this page

510(k) Report. “K926469: Variant (TM) Hemoglobin a 1C Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926469

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026