Wako Autokit Micro TP

510(k) Number

K920531 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

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 is the Wako Autokit Micro TP used for in a clinical setting?

  The Wako Autokit Micro TP is a Biuret (Colorimetric) Total Protein assay kit designed for quantitative measurement of total protein levels in serum or plasma. It uses a colorimetric reaction to provide precise analytical results, making it suitable for routine use in clinical chemistry laboratories to monitor protein concentrations in patient samples.

• Is the Wako Autokit Micro TP intended for single-use or reusable applications?

  The Wako Autokit Micro TP is explicitly supplied as a single-use reagent kit for in vitro diagnostic use. This means each kit is meant to be used once and discarded, eliminating the need for sterilization beyond the manufacturer-provided packaging.

• How is the Wako Autokit Micro TP regulated in the United States?

  The Wako Autokit Micro TP holds FDA 510(k) clearance under the product code CEK, with the clearance number K920531. This classification confirms it is deemed substantially equivalent to a predicate device and falls under the Clinical Chemistry category, adhering to regulatory standards for in vitro diagnostic assays.

• What type of laboratory setting is the Wako Autokit Micro TP intended for?

  The Wako Autokit Micro TP is specifically intended for use in clinical chemistry laboratories. Its design supports precise total protein quantification in serum or plasma samples, making it a specialized tool for diagnostic testing within this specialized field.

• Does the Wako Autokit Micro TP require any special handling beyond standard storage conditions?

  The kit is supplied in manufacturer-provided packaging that ensures sterility and integrity for single-use applications. While the exact storage conditions and shelf life are not detailed in the regulatory data, it is standard practice for such diagnostic reagents to follow the manufacturer’s guidelines for optimal performance and safety.