Calibrator for Automated Systems (C.F.A.S.) Proteins With Model 11355279160
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080607 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a calibrator for automated systems (C.F.A.S.) proteins, defined as a multi-analyte mixture used for calibration of quantitative Roche methods on clinical chemistry analyzers. It is a liquid ready-for-use calibrator based on human serum, with concentrations of its components adjusted to ensure optimal calibration of appropriate Roche methods.
It is supplied for use in clinical chemistry settings and is intended for in vitro diagnostic use. The device has received FDA 510(k) clearance under K080607, is classified as Class II with product code JIX, and is subject to special controls. It is not described as sterile, single-use, reusable, MRI safe, or with specific storage conditions in the provided data.
Frequently asked questions
What is the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 used for?
This device is a multi-analyte mixture used for calibration of quantitative Roche methods on clinical chemistry analyzers, ensuring accurate measurement of protein analytes in patient samples during in vitro diagnostic testing.
How is the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 supplied and prepared for use?
It is supplied as a liquid ready-for-use calibrator based on human serum, with component concentrations pre-adjusted to optimize calibration for appropriate Roche methods, requiring no additional preparation before use on automated systems.
Is the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 sterile, single-use, or reusable?
The provided data does not describe this device as sterile, single-use, or reusable; therefore, no claims can be made about its sterility or reuse characteristics based on the available information.
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: Calibrator for Automated Systems (C.f.a.s.) Proteins With Model ..., Calibrator for Automated Systems (C.f.a.s.) Proteins With Model ..., PDF C.f.a.s. Proteins - Biolab Diagnostici, K080607 FDA 510(k) - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080607 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K080607 24 fields · synced Sep 25, 2026