510(k) · Cleared
ClearedVITROS Immunodiagnostic Products CK-MB Reagent Pack
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 Jan 28, 2022 as substantially equivalent to K993068 (Ortho-Clinical Diagnostics, 1999) after a 158-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 28, 2022
- Review
- 158 days
- Class
- Class II
- Product code
- JHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973030 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK973030 Vitros Immunodiagnostics Products/CK-MB Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997 · Recalled
- 1 generation backK993068 Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros…Ortho-Clinical Diagnostics · 1999 · Recalled
- This deviceK212648 VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973030 | Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | 1 |
| −1 | K993068 | Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics | 1999 | 1 |
| 0 (this device) | K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | 2022 | — |
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
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 |
|---|---|---|---|
| * | K993068 | Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products…Summary page 4…/creatine kinase or isoenzymes test system. Product Code: JHX 4. Predicate VITROS Immunodiagnostic Products CK-MB Reagent Pack, K993068 Device 5. Device The VITROS Immunodiagnostic Products CK-MB assay is performed description using the VITROS CK-MB… | 1999 |
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 25 years and passes through 3 companies; a new generation was cleared every 22.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
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. 2022, this device’s year, is highlighted.
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?
For in vitro diagnostic use only.
For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
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/K212648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212648: VITROS Immunodiagnostic Products CK-MB Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212648
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