510(k) · Cleared
ClearedLiquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Sep 6, 2001 as substantially equivalent to K980556 (Bio-Rad, 1998) after a 24-day review. Its family tree reaches back 2 generations to 1996. 13 later devices descend from it.
- Decided
- Sep 6, 2001
- Review
- 24 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961828 (1996). 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- 1 generation backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
- This deviceK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
- Descendant · cites it directly · 12 of its ownK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
- Descendant · 2 generations on · 11 of its ownK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
- Descendant · 3 generations on · 8 of its ownK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
- Descendant · 4 generations on · 1 of its ownK123663 Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level…Bio-Rad Laboratories · 2012
- Descendant · 4 generations on · 1 of its ownK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002 · cites it directly12descendants
- K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004 · 2 generations on11descendants
- K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad · 2005 · 3 generations on8descendants
- K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories · 2012 · 4 generations on1descendant
- K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps · 2012 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| −1 | K980556 | Liquichek Cardiac Markers Control LT | Bio-Rad | 1998 | — |
| 0 (this device) | K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 | Bio-Rad | 2001 | — |
| +1 | K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel | Bio-Rad | 2002 | — |
| +2 | K040277 | Liquichek Cardiac Marker Control LT | Bio-Rad Laboratories, Inc. | 2004 | — |
| +3 | K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control… | Bio-Rad | 2005 | — |
| +4 | K123663 | Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3… | Bio-Rad Laboratories | 2012 | — |
| +4 | K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex… | Radiometer Medical Aps | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980556 | Liquichek Cardiac Markers Control LTSummary page 1…er: CFR 862.1660 3.0 Device to Which Substantial Equivalence is Claimed LiquivchekTM Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California Docket Number: K980556 4.0 Description of Device Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human a… | 1998 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel | 2002 | 12 |
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 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021498 (Bio-Rad, 2002) has gone furthest, with 12 descendants of its own.
How does its category compare?
All JJT devicesJJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJT
1in 2009
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJT
1in 2011
MAUDE reports naming product code JJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An assayed quality control serum to monitor the precision cf laboratory teating procedures for analytes 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.
https://510kreport.com/device/K012656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012656: Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026