510(k) Report

510(k) · Cleared

Cleared

Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel

K021498510(k) TraditionalCleared May 24, 200215-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 · JJT Enzyme Controls (Assayed And Unassayed)

Cleared on May 24, 2002 as substantially equivalent to K012656 (Bio-Rad, 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1996. 12 later devices descend from it.

Decided
May 24, 2002
Review
15 days
Class
Class I
Product code
JJT
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K961828 (1996). 12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 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 · 20011995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K012656 · 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 · 3 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. 2 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. 1 generation backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. This deviceK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. Descendant · cites it directly · 11 of its ownK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. Descendant · 2 generations on · 8 of its ownK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. Descendant · 3 generations on · 1 of its ownK123663 Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level…Bio-Rad Laboratories · 2012
  8. Descendant · 3 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 · 3 generations on · 1 of its ownK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12012: 32014: 12015: 22016: 12017: 1
2004high 3 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004 · cites it directly11descendants
  • K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad · 2005 · 2 generations on8descendants
  • K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories · 2012 · 3 generations on1descendant
  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps · 2012 · 3 generations on1descendant
  • K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps · 2012 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
201230
201410
201520
201610
201710
FIG. 1 — Lineage of K021498, 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 JJT? 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
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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
*K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648
Summary page 1
…on Number: CFR 862.1660 Device to Which Substantial Equivalence is Claimed Bio-Rad Laboratories Irvine, California Liquichek™ Cardiac Markers Control LT Docket Number: K012656 Liquichek™ Cardiac Markers Docket Number: K961828 Description of Device Liquichek™ iCaridiac Markers Control LT is prepared fr…
Bio-Rad2001—
*K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)
Summary page 1
…l Equivalence is Claimed Bio-Rad Laboratories Irvine, California Liquichek™ Cardiac Markers Control LT Docket Number: K012656 Liquichek™ Cardiac Markers Docket Number: K961828 Description of Device Liquichek™ iCaridiac Markers Control LT is prepared from human serum with added constituents of human and…
Bio-Rad1996—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.200411

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 6 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K040277 (Bio-Rad Laboratories, Inc., 2004) has gone furthest, with 11 descendants of its own.

How does its category compare?

All JJT devices

JJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJT

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJT

Too few JJT 510(k)s in any year since 2007 to give a median.

Recalls per year · JJT

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JJT

1in 2011

2007: 12009: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JJT, 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
20070—01
20080—00
20091—01
20100—01
20110—01
20120—10
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Liquichek Cardiac Markers Control LT is intended for use as an assayed

quality control serum to monitor the precision of laboratory testing

procedures listed in the package insert.

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 JJT

The JJT category page

  • K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
  • K062751Modification to Quantimetrix Cardiasure Cardiac MarkerQuantimetrix Corp. · 2006
  • K030768Cliniqa Liquid QC Cardiac Marker Control Levels 1, 2 & 3, Tri-LevelCliniqa Corporation · 20031 recall
  • K030102Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC · 2003
  • K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001

https://510kreport.com/device/K021498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021498: Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021498

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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