510(k) · Cleared
Recalled · Class II · 2017Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Feb 27, 2009 as substantially equivalent to K081731 (Siemens Healthcare Diagnostics, 2008) after a 95-day review. Its family tree reaches back 2 generations to 1984. It has been recalled once.
- Decided
- Feb 27, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- CGS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K834502 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK834502 CK-Nac ReagentRoche Diagnostic Systems, Inc. · 1984
- 1 generation backK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008 · Recalled
- This deviceK083465 Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension…Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K834502 | CK-Nac Reagent | Roche Diagnostic Systems, Inc. | 1984 | — |
| −1 | K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | 1 |
| 0 (this device) | K083465 | Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista… | Siemens Healthcare Diagnostics | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 CGS? 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 CGS device
- #1 K191296 Pointe Scientific Creatinine Kinase (CK)…score -0.2 · 1 generation · 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 |
|---|---|---|---|
| * | K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Summary page 1…duct Code: JHS, Differential rate kinetic method, cpk or isoenzymes 4. Panel: Clinical Chemistry F. Predicate Devices: Dimension® (CKI) Flex® Reagent Cartridge (DF38) - K081731 Dimension® (MBI) Flex® Reagent Cartridge (DF32) - K081731 G. Device Description: Dimension Vista® (CKI) Flex® Reagent Cartridge… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-1659-2018 | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 24.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K081731.
How does its category compare?
All CGS devicesCGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CGS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CGS
Too few CGS 510(k)s in any year since 2007 to give a median.
Recalls per year · CGS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGS
2in 2025
MAUDE reports naming product code CGS, 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 | 1 | — | 1 | 64 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1,434 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista ® clinical chemistry 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. The CKI method is an in vitro diagnostic…
Read the full statement (116 words)
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista ® clinical chemistry 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.
The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista ® clinical chemistry 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 as stated in the FDA summary.
https://510kreport.com/device/K083465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083465: Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083465
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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