510(k) · Cleared
Recalled · Class II · 2019ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Sep 7, 2016 as substantially equivalent to K991576 (Bayer Corp., 1999) and 1 other predicate after a 175-day review. Its family tree reaches back 3 generations to 1984. It has been recalled 2 times.
- Decided
- Sep 7, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- CGS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K834502 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK834502 CK-Nac ReagentRoche Diagnostic Systems, Inc. · 1984
- 2 generations backK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008 · Recalled
- 1 generation backK083579 Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009
- This deviceK160724 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme…Siemens Healthcare Diagnostics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K834502 | CK-Nac Reagent | Roche Diagnostic Systems, Inc. | 1984 | — |
| −2 | K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | 1 |
| −1 | K083579 | Dimension Vista System Enzyme 6 Calibrator, Model KC360 | Siemens Healthcare Diagnostics | 2009 | — |
| 0 (this device) | K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 4…l: o Clinical Chemistry o Clinical Chemistry 3. Identification of the Predicate Devices: ADVIA Chemistry Creatine Kinase (CKNAC) Assay - K991576 Dimension Vista ENZ 6 CAL - K083579 4. Device Description: ADVIA Chemistry Creatine Kinase Assay:… | 1999 |
| * | K083579 | Dimension Vista System Enzyme 6 Calibrator, Model KC360Summary page 4…o Clinical Chemistry 3. Identification of the Predicate Devices: ADVIA Chemistry Creatine Kinase (CKNAC) Assay - K991576 Dimension Vista ENZ 6 CAL - K083579 4. Device Description: ADVIA Chemistry Creatine Kinase Assay: ADVIA Chemistry Creatine Kinase (CK_L)… | 2009 |
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 |
|---|---|---|---|---|
| May 3, 2019 | Class II | Z-1914-2019 | Nonconforming Material/Component | A steady upward trend in blank (u) absorbance was observed |
| May 3, 2019 | Class II | Z-1913-2019 | Nonconforming Material/Component | A steady upward trend in blank (u) absorbance was observed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 11 other devices also cite its predicate K991576.
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. 2016, 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?
ADVIA Chemistry® Creatine Kinase (CK_L) Assay:
The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
ADVIA Chemistry® Enzyme 3 Calibrator:
ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK_L) assay on the ADVIA Chemistry systems.
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/K160724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160724
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