Sentinel Plasmaproteins Cal 3X
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081533 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)
The Sentinel Plasmaproteins Cal 3X is a Calibrator, Multi-Analyte Mixture (FDA Device Class II) designed for use in clinical chemistry assays. It provides standardized reference values for quantitative measurement of plasmaproteins, including Ceruloplasmin, Kappa light chains, Lambda light chains, and Transferrin, among others, via immunoturbidimetric methods.
Supplied as four 1 mL liquid bottles, this ready-to-use calibrator is prepared from human-based serum and intended exclusively for in vitro diagnostic calibration. It is not sterile, single-use only, and requires adherence to the manufacturer’s specified analytical procedures. Authorized under FDA 510(k) clearance (K081533), it complies with regulatory requirements for clinical chemistry applications.
Frequently asked questions
What specific plasmaproteins does the Sentinel Plasmaproteins Cal 3X calibrator measure, and how is it used in clinical settings?
The Sentinel Plasmaproteins Cal 3X calibrator is designed to provide standardized reference values for quantitative measurement of plasmaproteins such as Ceruloplasmin, Kappa light chains, Lambda light chains, and Transferrin. It is intended exclusively for use in clinical chemistry assays, specifically immunoturbidimetric methods, to ensure accurate calibration of diagnostic equipment. This helps laboratories maintain consistency in test results for monitoring conditions related to these proteins.
How is the Sentinel Plasmaproteins Cal 3X calibrator supplied, and is it meant for single-use only?
The Sentinel Plasmaproteins Cal 3X is supplied as four individual 1 mL liquid bottles, ready-to-use and prepared from human-based serum. It is explicitly labeled as single-use only, meaning each bottle should be used once and then discarded. This ensures accuracy and prevents cross-contamination between tests.
Is the Sentinel Plasmaproteins Cal 3X sterile, and what storage instructions should be followed?
The Sentinel Plasmaproteins Cal 3X is not sterile, as explicitly stated in its description. Since it is a non-sterile, ready-to-use calibrator, it should be stored according to the manufacturer’s guidelines—typically at room temperature or refrigerated (if specified) and protected from light and extreme temperatures. Always refer to the included instructions for precise storage conditions to maintain stability and accuracy.
What regulatory pathway was followed for FDA clearance of the Sentinel Plasmaproteins Cal 3X, and what does this mean for users?
The Sentinel Plasmaproteins Cal 3X received FDA clearance through a Traditional 510(k) pathway, with a decision code of *SESE* (Substantially Equivalent) under the advisory committee for Clinical Chemistry. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and performance in clinical chemistry applications. Users can rely on this clearance as confirmation of its compliance with FDA requirements for calibration purposes.
Are there multiple models or sizes available for the Sentinel Plasmaproteins Cal 3X, or is it supplied in a fixed configuration?
The Sentinel Plasmaproteins Cal 3X is supplied in a fixed configuration as four 1 mL liquid bottles per kit. There are no additional models or sizes listed in the available data, so this is the only version available for calibration of plasmaproteins via immunoturbidimetric assays. Always verify the exact contents and packaging with the manufacturer if ordering.
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: SENTINEL PLASMAPROTEINS CAL 3X (K081533) - Innolitics, SENTINEL CH. SPA A26854 Plasmaproteins Cal 3x - RevMed, PDF REVIEW MEMORANDUM - Food and Drug Administration, PDF REVIEW MEMORANDUM - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081533 | Class II | Active |
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Manufacturer
- Manufacturer
- Sentinel Ch. Spa
Sources (1)
- FDA 510(k) K081533 24 fields · synced Sep 19, 2026