Identifiers
- 510(k) Number
- K242585 FDA 510(k)
- FDA Product Code
- NDY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1225 FDA 510(k)
- Regulation Number
- 862.1225 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cystatin C is a test device in the Clinical Chemistry specialty. It is a Class 2 chemistry device with product code NDY.
The device received FDA 510(k) clearance (K242585) through the Traditional pathway and is substantially equivalent. It is manufactured by SENTINEL CH. SpA and located in Milan, Italy.
Frequently asked questions
What is the Cystatin C test device used for?
The Cystatin C test device is a Class 2 chemistry test used in the Clinical Chemistry specialty to measure cystatin C levels in biological samples, aiding in the assessment of kidney function as part of clinical laboratory testing.
How was the Cystatin C device cleared for market in the United States?
The Cystatin C device received FDA 510(k) clearance through the Traditional pathway under submission K242585, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class 2 medical device with product code NDY.
Who manufactures the Cystatin C test device and where is it produced?
The Cystatin C test device is manufactured by SENTINEL CH. SpA, located at Via Robert Koch, 2, Milan (Mi), Italy, with postal code 20152, as specified in the device registration and authorization records.
What regulatory classification and product code apply to the Cystatin C device?
The Cystatin C device is classified as a Class 2 medical device under FDA regulations, with the product code NDY, which corresponds to its categorization in the Clinical Chemistry specialty for in vitro diagnostic testing.
Is the Cystatin C device considered substantially equivalent to a predicate device?
Yes, the Cystatin C device was determined to be substantially equivalent (SESE) to a predicate device under FDA 510(k) clearance K242585, based on the Traditional review pathway and the decision code SESE, indicating it has the same intended use and technological characteristics as the predicate.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cystatin C - Sentinel Diagnostics, Downloads area - Sentinel Diagnostics, K242585 FDA 510 (k) - Cystatin C | SENTINEL CH. SpA, SENTINEL CH. SpA FDA 510 (k) Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242585 | Class II | Active |
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Manufacturer
- Manufacturer
- Sentinel Ch. Spa
Sources (1)
- FDA 510(k) K242585 24 fields · synced Sep 19, 2026