510(k) · Cleared
Recalled · 2003Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on Oct 4, 1999 as substantially equivalent to K973030 (Johnson & Johnson Clinical Diagnostics, Inc., 1997) after a 21-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 4, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- JHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973030 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973030 Vitros Immunodiagnostics Products/CK-MB Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997 · Recalled
- This deviceK993068 Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros…Ortho-Clinical Diagnostics · 1999
- Descendant · cites it directly · 0 of its ownK212648 VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973030 | Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | 1 |
| 0 (this device) | K993068 | Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics | 1999 | — |
| +1 | K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JHX device
- #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K973030 | Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators…Summary page 3…tic Products CK-MB Calibrators are substantially equivalent to VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with human serum which was cleared by the FDA (K973030) for [VD use. Table 1 lists the characteristics of the assays performed using the VITROS CK-MB assay for use with human serum an… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2003 | Not classified | Z-0298-04 | Other | Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K212648 (Ortho Clinical Diagnostics, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JHX devicesJHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHX
Too few JHX 510(k)s in any year since 2007 to give a median.
Recalls per year · JHX
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHX
1in 2025
MAUDE reports naming product code JHX, 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 | 2 |
| 2008 | 0 | — | 1 | 6 |
| 2009 | 1 | — | 1 | 40 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 1 | — | 4 | 18 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 2 | 8 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
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 and plasma 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 and plasma.
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/K993068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993068: Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993068
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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