Albp

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981457 ↗

FDA Product Code

CJW

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Abbott Mfg., Inc. →

• What is the ALBP Bromcresol Purple Albumin Reagent used for?

  The ALBP reagent quantifies serum albumin levels using a colorimetric dye-binding assay. This method measures protein concentration in patient samples, supporting diagnostic evaluations for nutritional status, liver function, and conditions affecting protein synthesis or loss, such as malnutrition or liver disease.

• How is the ALBP reagent supplied and intended for use?

  The ALBP is supplied as a ready-to-use solution designed exclusively for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use only, meaning each vial or container is meant to be used once and then discarded. No additional sterilization beyond standard laboratory practices is required.

• Is the ALBP reagent reusable or single-use?

  The ALBP reagent is explicitly designed for single-use only. This ensures accuracy and consistency in results, as repeated use could introduce contamination or degradation of the reagent, compromising diagnostic reliability. Always follow the manufacturer’s instructions for proper handling and disposal.

• What regulatory clearance does the ALBP reagent hold?

  The ALBP reagent holds FDA 510(k) clearance under the Traditional pathway, with clearance number K981457. This classification confirms that the device meets regulatory standards for safety and effectiveness as a Class 2 Clinical Chemistry device, ensuring compliance with 21 CFR Part 820 Quality System Regulation.

• How should the ALBP reagent be stored and handled?

  The ALBP reagent follows standard laboratory protocols for chemical reagents, which typically include storage in a cool, dry place away from direct sunlight or extreme temperatures. Always refer to the manufacturer’s instructions for specific storage conditions, as improper handling could affect reagent stability and assay accuracy. Ensure proper labeling and segregation to prevent cross-contamination.