Identifiers
- 510(k) Number
- K140112 FDA 510(k)
- FDA Product Code
- JIT 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)
The CA 125 II CalSet II is a secondary calibrator designed for use with immunoassay systems. It provides standardized reference materials for the quantitative measurement of CA 125 (cancer antigen 125) levels in human serum and plasma, aiding in the calibration of diagnostic assays for monitoring ovarian cancer and other gynecological conditions. The device supports accurate determination of OC 125 reactive determinants, which are associated with a high-molecular-weight glycoprotein linked to malignant processes.
This calibrator is intended for in vitro use on cobas e analyzers and is supplied as a ready-to-use liquid for clinical chemistry laboratories. It is supplied in single-use vials and requires no additional sterilization or preparation beyond standard laboratory procedures. The device is classified as a Class II medical device under FDA regulations (862.1150) and holds a 510K clearance for substantial equivalence in clinical chemistry applications. Storage conditions and expiration dates are specified on the packaging.
Frequently asked questions
What is the CA 125 II CalSet II used for?
The CA 125 II CalSet II is a secondary calibrator designed to standardize quantitative measurements of CA 125 (cancer antigen 125) in human serum and plasma. CA 125 is associated with ovarian cancer and other gynecological conditions, so this calibrator helps ensure accurate calibration of diagnostic assays for monitoring these conditions on cobas e immunoassay systems.
How is the CA 125 II CalSet II supplied and prepared for use?
The CA 125 II CalSet II is supplied as a ready-to-use liquid in single-use vials. No additional sterilization or preparation is required beyond standard laboratory procedures. Simply follow routine handling protocols for immunoassay calibrators in clinical chemistry laboratories.
Is the CA 125 II CalSet II single-use or reusable?
The CA 125 II CalSet II is supplied in single-use vials, meaning each vial is intended for one calibration procedure. This design minimizes contamination risk and ensures consistent results, aligning with best practices for secondary calibrators in clinical diagnostics.
What storage conditions should be followed for the CA 125 II CalSet II?
Storage conditions and expiration dates are clearly indicated on the packaging. Always adhere to these instructions to maintain product integrity. Improper storage could compromise accuracy, so verify the vial’s expiration date and storage requirements before use.
Which analyzers are compatible with the CA 125 II CalSet II?
The CA 125 II CalSet II is specifically designed for use with cobas e immunoassay systems. Compatibility is limited to these analyzers to ensure accurate calibration and reliable measurement of CA 125 levels in clinical settings.
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: Elecsys® CA 125 II - Roche Diagnostics USA, Elecsys CA 125 II - Roche, Elecsys® CA 125 II - Roche Diagnostics USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140112 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K140112 24 fields · synced Oct 1, 2026