← Back to catalogue

Centria Cortisol Ria

FDA 510(k)

Class II (US FDA 510(k))

510(k) K771117

by Clinical Diagnostics, Inc.

Identifiers

510(k) Number
K771117 FDA 510(k)
FDA Product Code
CGR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1205 FDA 510(k)
Regulation Number
862.1205 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Centria Cortisol Radioimmunoassay Test Set is a radioimmunoassay (RIA) device designed for the quantitative measurement of cortisol levels in serum or plasma. Cortisol is a steroid hormone produced by the adrenal glands, and its accurate measurement is critical for diagnosing and monitoring conditions such as adrenal insufficiency, Cushing’s syndrome, and stress-related disorders. This test employs a competitive binding assay, where cortisol in the sample competes with a radiolabeled cortisol tracer for limited antibody binding, enabling precise quantification through radioactivity detection.

This test set is supplied as a single-use diagnostic reagent kit and requires laboratory handling, including gamma counter analysis for signal detection. It is classified under FDA regulation 862.1205 and falls within device class 2, with a 510(k) clearance (K792243) under the traditional review pathway. The product code CGR identifies it as a radioimmunoassay for cortisol, intended exclusively for in vitro diagnostic use in clinical chemistry settings. No third-party review was involved, and the device adheres to standard sterility and performance requirements for its intended application.

Frequently asked questions

What is the Centria Cortisol RIA used for?

The Centria Cortisol RIA is designed for the quantitative measurement of cortisol levels in serum or plasma samples. Cortisol is a key steroid hormone produced by the adrenal glands, and accurate measurement is essential for diagnosing and monitoring conditions such as adrenal insufficiency, Cushing’s syndrome, and stress-related disorders. The test employs a competitive binding assay, where cortisol in the sample competes with a radiolabeled tracer for antibody binding, enabling precise detection via radioactivity.

How is the Centria Cortisol RIA supplied and what are its handling requirements?

The Centria Cortisol RIA is supplied as a single-use diagnostic reagent kit. It requires laboratory handling, including the use of a gamma counter for signal detection. The assay process involves competitive binding, where cortisol in the sample competes with a radiolabeled tracer for antibody sites, and the results are quantified through radioactivity measurement. This ensures accurate cortisol level determination in clinical settings.

Is the Centria Cortisol RIA sterile and intended for single-use?

Yes, the Centria Cortisol RIA adheres to standard sterility requirements for its intended in vitro diagnostic use. It is explicitly designed as a single-use diagnostic reagent kit, ensuring patient safety and preventing cross-contamination between samples. This aligns with regulatory expectations for radioimmunoassay devices in clinical chemistry.

What regulatory pathway and classification apply to the Centria Cortisol RIA?

The Centria Cortisol RIA is classified under FDA regulation 862.1205 as a Class 2 device and has received 510(k) clearance (K771117) under the traditional review pathway. The product code CGR identifies it as a radioimmunoassay for cortisol, intended exclusively for in vitro diagnostic use in clinical chemistry. No third-party review was involved, and it complies with standard sterility and performance requirements for its application.

Can this device be used for any other purposes besides cortisol measurement?

The Centria Cortisol RIA is specifically intended for the quantitative measurement of cortisol in serum or plasma samples. Its design and regulatory classification (product code CGR) restrict its use to cortisol detection via radioimmunoassay in clinical chemistry settings. It is not approved or indicated for measuring other hormones or substances, nor is it intended for use outside of in vitro diagnostic applications.

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: CENTRIA CORTISOL RIA TEST SET (K792243) — FDA 510(k) | Innolitics, PDF K792243 - Centria Cortisol Ria Test Set, CENTRIA CORTISOL RIA TEST SET 510 (k) K792243 - FDA.report, PDF K780725 CENTRIA CORTISOL RIA - 510kdatabase.net, Cortisol, RIA CT, 96 tests | DiaSource Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Clinical Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K771117 24 fields · synced Oct 1, 2026