510(k) · Cleared
ClearedElitech Clinical Systems CK Nac SL
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 Aug 22, 2012 as substantially equivalent to K063744 (Rochdiag, 2007) and 2 other predicates after a 37-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Aug 22, 2012
- Review
- 37 days
- Class
- Class II
- Product code
- JHW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K781921 (1979). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 3 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 2 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 1 generation backK063744 Cobas Integra C 111Rochdiag · 2007
- This deviceK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
- Descendant · cites it directly · 0 of its ownK141265 Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014
Most influential descendants
Showing 1 of 1 · See all- K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −3 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −2 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −1 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| 0 (this device) | K122083 | Elitech Clinical Systems CK Nac SL | Elitechgroup | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K063744 | Cobas Integra C 111Summary page 1…ss 1,reserved JJY Clinical Chemistry 21 CFR 862.1660 5. Predicate Device: k063744 Roche Diagnostics CKL k033501… | 2007 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 1…21 CFR 862.1660 5. Predicate Device: k063744 Roche Diagnostics CKL k033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.)… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 1…k033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.) k041227 Roche Diagnostics Precinorm and Precipath 6. Intended Use… | 2004 |
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 |
|---|---|---|---|
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent Kit | 2014 | 0 |
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 33 years and passes through 5 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K141265 (Elitechgroup, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K063744.
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. 2012, 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?
ELiTech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (OK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. ELiTech Clinical…
Read the full statement (124 words)
ELiTech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (OK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems on ELITech Clinical Systems Selectra analyzers.
ELiTech Clinical Systems ELITROL I & ELITROL 11are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122083: Elitech Clinical Systems CK Nac SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122083
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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