510(k) · Cleared
ClearedLiquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)
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 Jun 11, 1996 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 20 later devices descend from it.
- Decided
- Jun 11, 1996
- Review
- 29 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 1
20 later devices descend from it, 6 citing it directly.
- This deviceK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- Descendant · cites it directly · 14 of its ownK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
- Descendant · 2 generations on · 13 of its ownK012656 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K980556Liquichek Cardiac Markers Control LTBio-Rad · 1998 · cites it directly14descendants
- K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001 · 2 generations on13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| +1 | K980556 | Liquichek Cardiac Markers Control LT | Bio-Rad | 1998 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K903430 | FDA’s K903430 is Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980556 | Liquichek Cardiac Markers Control LT | 1998 | 14 |
| K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel | 2002 | 12 |
| K981622 | Dade Tru-Liquid Cardiac Control | 1998 | 1 |
| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer | 2007 | 0 |
| K973974 | Dade Tru-Liquid Cardiac Control | 1997 | 0 |
| K970976 | Cardioimmune Cardiac Marker Control, Levels 1,2 and 3 | 1997 | 0 |
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, K980556 (Bio-Rad, 1998) has gone furthest, with 14 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?
Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s specific cardiac marker procedures.
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/K961828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961828
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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