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Reagent, Total Protein Determination

FDA 510(k)

Class II (US FDA 510(k))

510(k) K760480

by Simmler & Son, Inc.

Identifiers

510(k) Number
K760480 FDA 510(k)
FDA Product Code
CEK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1635 FDA 510(k)
Regulation Number
862.1635 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This reagent is a Biuret (colorimetric) Total Protein diagnostic test, designed for quantitative determination of total protein levels in serum or plasma samples. It employs a colorimetric reaction to measure protein concentration, providing a reliable analytical result for clinical chemistry applications.

The reagent is supplied as a single-use, non-sterile chemical solution intended for in vitro diagnostic use in clinical laboratories. It is classified under FDA regulation 862.1635 as a Class II device, with an FDA 510(k) clearance (K760480) under the Traditional pathway. No third-party review was required, and it is not intended for MRI or other imaging environments. Storage conditions and additional handling instructions are specified in the accompanying documentation.

Frequently asked questions

What clinical chemistry applications is this reagent intended for, and how does it work?

This reagent is designed for quantitative determination of total protein levels in serum or plasma samples within clinical chemistry laboratories. It uses a Biuret colorimetric reaction, which measures protein concentration by producing a color change proportional to the protein amount present. This method provides a reliable analytical result for monitoring protein levels in patient samples.

Is this reagent single-use, and what are the storage requirements?

Yes, this reagent is supplied as a single-use, non-sterile chemical solution, meaning each vial is intended for one test. Storage conditions and handling instructions are detailed in the accompanying documentation, though specifics like temperature or light exposure are not provided in the data. Always follow the manufacturer’s guidelines to maintain reagent integrity.

What regulatory pathway was used for FDA clearance, and is third-party review required?

This reagent received FDA 510(k) clearance (K760480) under the Traditional pathway, meaning it was determined substantially equivalent to a predicate device. No third-party review was required, and it is classified as a Class II device under FDA regulation 862.1635. The clearance was filed in 1976 and remains valid for its intended use.

Are there different sizes or models available for this reagent?

The provided data does not specify distinct sizes or models beyond the single-use vial format for in vitro diagnostic use. However, the registration numbers and product codes (e.g., CEK) suggest multiple lot or batch variations may exist, but these do not imply different reagent formulations or clinical applications. Always verify the exact lot or variant with the manufacturer.

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: REAGENT, TOTAL PROTEIN DETERMINATION (K760480) — FDA 510 (k) | Innolitics, REAGENT, TOTAL PROTEIN DETERMINATION 510(k) K760480 - FDA.report, Simmler & Son, Inc. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Simmler & Son, Inc.

Sources (1)

  • FDA 510(k) K760480 24 fields · synced Sep 19, 2026