510(k) · Cleared
ClearedDade Tru-Liquid Cardiac Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Intl., Inc. · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Nov 6, 1997 as substantially equivalent to K961828 (Bio-Rad, 1996) after a 17-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 6, 1997
- Review
- 17 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961828 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- This deviceK973974 Dade Tru-Liquid Cardiac ControlDade Intl., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| 0 (this device) | K973974 | Dade Tru-Liquid Cardiac Control | Dade Intl., Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Summary page 1…f intended use and safety and effectiveness to the Liquichek Cardiac Markers Control manufactured by Bio-Rad Laboratories, previously cleared under Document Control No., K961828. 48 & TRVICE p“s * Uy 5y C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service § REALTY 4 O "’0 2 ¥r… | 1996 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K961828.
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?
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality
control material in clinical laboratory quality assurance programs and to
assist in the control of accuracy and precision of a laboratory's 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/K973974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973974: Dade Tru-Liquid Cardiac Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973974
Report an extraction error
Are you the manufacturer?
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