510(k) Report

510(k) · Cleared

Cleared

Liquichek Cardiac Marker Control LT

K040277510(k) TraditionalCleared Mar 10, 200434-day reviewClass I21 CFR 862.1660

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. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Mar 10, 2004 as substantially equivalent to K021498 (Bio-Rad, 2002) after a 34-day review. Its family tree reaches back 4 generations to 1996. 11 later devices descend from it.

Decided
Mar 10, 2004
Review
34 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K961828 (1996). 11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2006: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2012: 3 descendants cleared2017: 1 descendant cleared2016: 1 descendant clearedK961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 1996K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 20021995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 2002K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 19960
  1. Root · 4 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. 3 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. 2 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. 1 generation backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. This deviceK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. Descendant · cites it directly · 8 of its ownK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. Descendant · 2 generations on · 1 of its ownK123663 Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level…Bio-Rad Laboratories · 2012
  8. Descendant · 2 generations on · 1 of its ownK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
  9. Descendant · 2 generations on · 1 of its ownK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps · 2012
  10. Descendant · 3 generations on · 0 of its ownK163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12012: 32014: 12015: 22016: 12017: 1
2005high 3 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all
  • K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad · 2005 · cites it directly8descendants
  • K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories · 2012 · 2 generations on1descendant
  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps · 2012 · 2 generations on1descendant
  • K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps · 2012 · 2 generations on1descendant
  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad1996—
−3K980556Liquichek Cardiac Markers Control LTBio-Rad1998—
−2K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad2001—
−1K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad2002—
0 (this device)K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.2004—
+1K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control…Bio-Rad2005—
+2K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3…Bio-Rad Laboratories2012—
+2K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex…Radiometer Medical Aps2012—
+2K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps2012—
+3K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
201230
201410
201520
201610
201710
FIG. 1 — Lineage of K040277, 1996–2017Source: 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 JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel
Summary page 2
…Liquichek TM Cardiac Markers Control LT N Device) Predicate Device K021498) Intended Use Liquichek Cardiac Markers Control LT is intended for use as an Liquichek Cardiac Markers C…
Bio-Rad2002—
*—Liquichek Cardiac Markers Control
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad20058
K053247Validate Cardiac Marker (CM1) Calibration Verification Test SetMaine Standards Co.20060
K043584Liquichek BNP ControlBio-Rad Laboratories, Inc.20050

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 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K050537 (Bio-Rad, 2005) has gone furthest, with 8 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

What is it indicated for?

For use as an assayed quality control' serum to monitor the precision

of laboratory testing procedures for the analytes listed in the package

insert.

Indications for use as stated in the FDA summary.

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 JJY

The JJY category page

  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017
  • K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K040277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040277: Liquichek Cardiac Marker Control LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040277

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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