510(k) · Cleared
ClearedElitech Clinical Systems Envoy 500 CK Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · JHW U.V. Method, Cpk Isoenzymes
Cleared on Jul 18, 2014 as substantially equivalent to K122083 (Elitechgroup, 2012) after a 64-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Jul 18, 2014
- Review
- 64 days
- Class
- Class II
- Product code
- JHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K781921 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 4 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 3 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 2 generations backK063744 Cobas Integra C 111Rochdiag · 2007
- 1 generation backK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
- This deviceK141265 Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −4 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −3 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −2 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| −1 | K122083 | Elitech Clinical Systems CK Nac SL | Elitechgroup | 2012 | — |
| 0 (this device) | K141265 | Elitech Clinical Systems Envoy 500 CK Reagent Kit | Elitechgroup | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 JHW? 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 |
|---|---|---|---|
| * | K122083 | Elitech Clinical Systems CK Nac SLSummary page 1…JHW Clinical Chemistry 21 CFR 862.1215 5. Predicate Device: K122083 ELITech Clinical Systems SAS ELITech Clinical… | 2012 |
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 35 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All JHW devicesJHW U.V. Method, Cpk Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JHW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JHW
Too few JHW 510(k)s in any year since 2007 to give a median.
Recalls per year · JHW
No recall names JHW since 2007.
Adverse event reports per year · JHW
1in 2024
MAUDE reports naming product code JHW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of crestine kinase (CK) in human serum and plasma using the ENVOY 500 Chemistry System.
It is not intended for use in Point of Care settings.
Creatine phosphokinase and its iscozymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141265
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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