510(k) Report

510(k) · Cleared

Cleared

Liquichek Cardiac Markers Control LT

K980556510(k) TraditionalCleared Feb 25, 199812-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 Feb 25, 1998 as substantially equivalent to K961828 (Bio-Rad, 1996) after a 12-day review. Its family tree reaches back 1 generation to 1996. 14 later devices descend from it.

Decided
Feb 25, 1998
Review
12 days
Class
Class I
Product code
JJT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K961828 (1996). 14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2004: 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 · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants K961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 19960+5
  1. Root · 1 generation backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. This deviceK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. Descendant · cites it directly · 13 of its ownK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. Descendant · 2 generations on · 12 of its ownK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. Descendant · 3 generations on · 11 of its ownK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. Descendant · 4 generations on · 8 of its ownK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. Descendant · 5 generations on · 1 of its ownK123663 Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level…Bio-Rad Laboratories · 2012

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12004: 12005: 22006: 12012: 32014: 12015: 22016: 12017: 1
2001high 3 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 14 · See all
  • K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001 · cites it directly13descendants
  • K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002 · 2 generations on12descendants
  • K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004 · 3 generations on11descendants
  • K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad · 2005 · 4 generations on8descendants
  • K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories · 2012 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad1996—
0 (this device)K980556Liquichek Cardiac Markers Control LTBio-Rad1998—
+1K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad2001—
+2K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad2002—
+3K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.2004—
+4K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control…Bio-Rad2005—
+5K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3…Bio-Rad Laboratories2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200410
200520
200610
201230
201410
201520
201610
201710
FIG. 1 — Lineage of K980556, 1996–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

What was it cleared against? (1)

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
*K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)
Summary page 1
…2.1660: Quality Control Material (Assayed and Unassayed) Devi Which Substantial Equival is Claimed Liquichek Cardiac Markers Control Bio-Rad Laboratories, Anaheim, CA K961828 Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an indi…
Bio-Rad1996—

Also cleared against K961828: 5 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad200113

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?

  • Its one ancestor has no recall.
  • Of its descendants, K012656 (Bio-Rad, 2001) has gone furthest, with 13 descendants of its own.
  • 5 other devices also cite its predicate K961828.

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 an individual laboratory’s

specific cardiac markers procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K961828

5 other devices cite the same predicate.

  • K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007
  • K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  • K981622Dade Tru-Liquid Cardiac ControlDade Behring, Inc. · 1998
  • K973974Dade Tru-Liquid Cardiac ControlDade Intl., Inc. · 1997
  • K970976Cardioimmune Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc. · 1997

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
  • K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002

https://510kreport.com/device/K980556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980556: Liquichek Cardiac Markers 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/K980556

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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