Wako Autokit Albumin

Full name

Wako(Tm) Autokit Albumin

510(k) Number

K880313 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →

• What clinical chemistry measurement does the Wako Autokit Albumin specifically enable, and how does it work?

  The Wako Autokit Albumin is designed for the quantitative measurement of serum albumin levels using a colorimetric assay. It employs bromcresol green dye, which binds to albumin in patient samples. The resulting complex is then detected spectrophotometrically, allowing for precise concentration determination. This method is commonly used in clinical chemistry laboratories to assess liver function, nutritional status, and overall protein balance in patients.

• Is this reagent kit intended for use with specific types of laboratory equipment, and what storage conditions are required?

  Yes, the Wako Autokit Albumin is specifically intended for use with automated chemistry analyzers in clinical chemistry laboratories. It is supplied as a single-use, non-sterile reagent kit. Storage is straightforward—simply refrigerate the kit between 2°C and 8°C, following the instructions provided. No additional specialized storage conditions are required.

• How is the Wako Autokit Albumin regulated in the U.S., and what classification does it hold?

  The Wako Autokit Albumin holds FDA 510(k) clearance under the Traditional review pathway, with a classification as a Class II device (CIX). This designation reflects its role as a diagnostic reagent for in vitro use in clinical chemistry, ensuring it meets regulatory standards for safety and performance without requiring the stringent controls of a Class III device.

• Can this reagent be reused, and what are the implications of its single-use nature?

  No, the Wako Autokit Albumin is explicitly designed for single-use only. This ensures accuracy and reliability in measurements, as repeated use could introduce variability or contamination. The single-use nature aligns with best practices in clinical chemistry to maintain precision and patient safety, particularly in automated systems where consistency is critical.

• What are the key details about the manufacturer and regulatory submission history for this product?

  The Wako Autokit Albumin is manufactured by Wako Chemicals USA, Inc., based in Dallas, TX. The product was submitted for FDA clearance in 1988 under the advisory committee for Clinical Chemistry (CH) and holds the clearance number K880313. The submission was determined to be substantially equivalent (SESE) to a predicate device, reflecting its classification as a well-established diagnostic reagent in the field of clinical chemistry.