510(k) · Cleared
ClearedValidate Cardiac Marker (CM1) Calibration Verification Test Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 13, 2006 as substantially equivalent to K040277 (Bio-Rad Laboratories, Inc., 2004) after a 53-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jan 13, 2006
- Review
- 53 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961828 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- 4 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
- 3 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
- 2 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
- 1 generation backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
- This deviceK053247 Validate Cardiac Marker (CM1) Calibration Verification Test SetMaine Standards Co. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| −4 | K980556 | Liquichek Cardiac Markers Control LT | Bio-Rad | 1998 | — |
| −3 | K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 | Bio-Rad | 2001 | — |
| −2 | K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel | Bio-Rad | 2002 | — |
| −1 | K040277 | Liquichek Cardiac Marker Control LT | Bio-Rad Laboratories, Inc. | 2004 | — |
| 0 (this device) | K053247 | Validate Cardiac Marker (CM1) Calibration Verification Test Set | Maine Standards Co. | 2006 | — |
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? (2)
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 |
|---|---|---|---|
| * | K040277 | Liquichek Cardiac Marker Control LTSummary page 1…n selected as the "best fit" FDA code for this product. Regulatory Class: Class I Predicate Device: 1. Bio-Rad Liquichek Cardiac Markers Control LT (K040277), Bio-Rad Laboratories, Irvine, CA 2. DOCUMENT CK-MB CALoVER, Microgenics Corporation, Fremont, CA Not… | 2004 |
| * | — | DOCUMENT CK-MB CALoVER Named without a submission number |
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 10 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K040277.
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.
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?
The VALIDATE ® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053247 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053247: Validate Cardiac Marker (CM1) Calibration Verification Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053247
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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