510(k) · Cleared
Recalled · Class II · 2017Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32
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 Aug 29, 2008 as substantially equivalent to K834502 (Roche Diagnostic Systems, Inc., 1984) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1984. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- CGS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K834502 (1984). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK834502 CK-Nac ReagentRoche Diagnostic Systems, Inc. · 1984
- This deviceK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008
- Descendant · cites it directly · 1 of its ownK083579 Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009
- Descendant · 2 generations on · 0 of its ownK160724 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK083465 Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension…Siemens Healthcare Diagnostics · 2009 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K083579Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009 · cites it directly1descendant
- K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on0descendants
- K083465Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K834502 | CK-Nac Reagent | Roche Diagnostic Systems, Inc. | 1984 | — |
| 0 (this device) | K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | — |
| +1 | K083579 | Dimension Vista System Enzyme 6 Calibrator, Model KC360 | Siemens Healthcare Diagnostics | 2009 | — |
| +2 | K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3… | Siemens Healthcare Diagnostics, Inc. | 2016 | 2 |
| +1 | K083465 | Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista… | Siemens Healthcare Diagnostics | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K834502 | CK-Nac ReagentSummary page 1…ion: Class II 3. Product Code: JIX, Calibrator, Multi-Analyte Mixture 4. Panel: Clinical Chemistry F. Predicate Devices: Roche Diagnostic Systems Inc. CK-NAC Reagent (K834502) Roche Diagnostic Systems Inc. CK-MB Reagent (K003158) Roche Diagnostic Systems Inc. Calibrator for Automated Systems (K990… | 1984 |
| * | K003158 | Roche Diagnostics CK-MBSummary page 1…lyte Mixture 4. Panel: Clinical Chemistry F. Predicate Devices: Roche Diagnostic Systems Inc. CK-NAC Reagent (K834502) Roche Diagnostic Systems Inc. CK-MB Reagent (K003158) Roche Diagnostic Systems Inc. Calibrator for Automated Systems (K990460) Roche Diagnostic Systems Inc. Calibrator for Auto… | 2000 |
| * | K990460 | Calibrator for Automated Systems (C.F.a.S.)Summary page 1…gnostic Systems Inc. CK-NAC Reagent (K834502) Roche Diagnostic Systems Inc. CK-MB Reagent (K003158) Roche Diagnostic Systems Inc. Calibrator for Automated Systems (K990460) Roche Diagnostic Systems Inc. Calibrator for Automated Systems, CKMB (K003158) G. Device Description: Dimension®(CKI) Fle… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1653-2018 | 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?
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. 2008, 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® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatmentof myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The CKI method is an in vitro diagnostic test for…
Read the full statement (140 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® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatmentof 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 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/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081731
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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