510(k) · Cleared
Recalled · Class III · 2013Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators (Gem.C300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 4, 1997 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 4, 1997
- Review
- 21 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK973030 Vitros Immunodiagnostics Products/CK-MB Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK993068 Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros…Ortho-Clinical Diagnostics · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK212648 VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973030 | Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| +1 | K993068 | Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics | 1999 | 1 |
| +2 | K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993068 | Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products… | 1999 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2013 | Class III | Z-1337-2013 | Process control | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993068 (Ortho-Clinical Diagnostics, 1999) has gone furthest, with 1 descendant of its own.
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?
VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum in the diagnosis and treatment of myocardial infarction.
VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum.
VITROS Cardiology Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of CK-MB.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973030: Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators (Gem.C300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973030
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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