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Albumin BCP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193001

by Sentinel Ch. Spa

Identifiers

510(k) Number
K193001 FDA 510(k)
FDA Product Code
CJW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1035 FDA 510(k)
Regulation Number
862.1035 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Albumin BCP is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. It is based on the bromcresol purple dye-binding method for albumin measurement.

The assay is intended for professional use only and is supplied in configurations such as 6x50 mL and 6x20 mL. It is classified as a Class II medical device under regulation number 862.1035 and has received FDA 510(k) clearance (K193001) as substantially equivalent to a predicate device.

Frequently asked questions

What is Albumin BCP used for?

Albumin BCP is an in vitro diagnostic test used for the determination of albumin in human serum or plasma, based on the bromcresol purple dye-binding method for albumin measurement.

How is Albumin BCP supplied and configured?

Albumin BCP is supplied in configurations such as 6x50 mL and 6x20 mL, intended for professional use only in clinical laboratory settings.

Is Albumin BCP a single-use or reusable test?

Albumin BCP is supplied as reagent kits for in vitro diagnostic use; the test itself is performed on patient samples, and the reagents are consumed during the assay, making them single-use in application.

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 CH. SPA C22856 Albumin BCP (6x50 mL), SENTINEL CH. SPA C22855 Albumin BCP (6x20 mL) - RevMed, Albumin BCP (6x50 mL) C22856 Medical Device Identification, Albumin BCP (6x20 mL) - BEUDAMED, Albumin BCP R1 20 mL - Free SDS search - msds.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sentinel Ch. Spa

Sources (1)

  • FDA 510(k) K193001 24 fields · synced Sep 25, 2026