510(k) · Cleared
ClearedHydragel-Mini Iso-CK Kit, Hydragel Iso-CK Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-CK 15/30 Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morax · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Dec 29, 1999 after a 188-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 29, 1999
- Review
- 188 days
- Class
- Class II
- Product code
- CGS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
All Sebia’s Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes, MM, MB and BB, by electrophoresis on alkaline buffered agarose gels followed by a densitometry. The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute mwocardial infarction o(AMI) from those with other coronary…
Read the full statement (186 words)
All Sebia’s Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes, MM, MB and BB, by electrophoresis on alkaline buffered agarose gels followed by a densitometry.
The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute mwocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms.
Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD :soenzymes which are released slower from the injured heart muscle and remain. longer in circulation, to confirm or rule out the diagnosis of MI, assess its severity and monitor patient’s condition.
The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992148 · printed Nov 3, 2026
Cite this page
510(k) Report. “K992148: Hydragel-Mini Iso-CK Kit, Hydragel Iso-CK Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-CK 15/30 Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K992148
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026