510(k) · Cleared
ClearedCK-Nac Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Feb 27, 1984 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 27, 1984
- Review
- 68 days
- Class
- Class II
- Product code
- CGS
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK834502 CK-Nac ReagentRoche Diagnostic Systems, Inc. · 1984
- Descendant · cites it directly · 3 of its ownK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK083579 Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 1 of its ownK992140 Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK200865 Piccolo Potassium Test SystemAbaxis, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK160724 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics · 2008 · cites it directly3descendants
- K083579Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics · 2009 · 2 generations on1descendant
- K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 1999 · cites it directly1descendant
- K200865Piccolo Potassium Test SystemAbaxis, Inc. · 2021 · 2 generations on0descendants
- K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K083579 | Dimension Vista System Enzyme 6 Calibrator, Model KC360 | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K992140 | Piccolo Metlyte 7 Reagent Disc | Abaxis, Inc. | 1999 | 2 |
| +2 | K200865 | Piccolo Potassium Test System | Abaxis, Inc. | 2021 | — |
| +3 | K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3… | Siemens Healthcare Diagnostics, Inc. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081731 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 3 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K834502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K834502: CK-Nac Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834502
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026