510(k) · Cleared
ClearedLiquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 6, 2014 as substantially equivalent to K050537 (Bio-Rad, 2005) after a 26-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- May 6, 2014
- Review
- 26 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961828 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- 5 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
- 4 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
- 3 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
- 2 generations backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
- 1 generation backK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
- This deviceK140916 Liquichek Cardiac Troponins Control, Levels 1,2 and 3…Bio-Rad Laboratories · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| −5 | K980556 | Liquichek Cardiac Markers Control LT | Bio-Rad | 1998 | — |
| −4 | K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 | Bio-Rad | 2001 | — |
| −3 | 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 | — |
| −1 | K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control… | Bio-Rad | 2005 | — |
| 0 (this device) | K140916 | Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/Minipak | Bio-Rad Laboratories | 2014 | — |
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
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 |
|---|---|---|---|
| * | K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Summary page 1…Which Substantial Equivalence is Claimed Liquichek Cardiac Markers Plus Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K050537 4.0 Description of Device Liquichek Cardiac Troponins Control is a trilevel liquid control prepared from human… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- 5 other devices also cite its predicate K050537.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Liquichek Cardiac Troponins Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
- Troponin I
- Troponin T
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/K140916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140916: Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140916
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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