Wako Autokit LP(A) & LP(A) Calibrator/Cobas Bio

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K001933 ↗

FDA Product Code

DFC

Device Class

Class II

Regulation

21 CFR Part 866.5600

Advisory Committee

Immunology

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 LP(A) Calibrator used for in clinical settings?

  The Wako Autokit LP(A) Calibrator is designed as a reference standard for calibrating and validating immunology assays that measure low-density lipoprotein (LDL) cholesterol and related antigens. It helps ensure accurate diagnostic results by providing a consistent benchmark for LDL testing on the COBAS BIO analyzer system, which is critical for reliable patient monitoring and treatment decisions.

• How is the Wako Autokit LP(A) Calibrator supplied, and is it single-use?

  The Wako Autokit LP(A) Calibrator is supplied as a single-use calibrator, meaning each unit is intended for one-time use in laboratory testing. This design minimizes contamination risks and ensures consistent performance, aligning with standard laboratory protocols for reagent controls. Single-use calibrators are particularly important in clinical settings where precision and sterility are paramount.

• What analyzer system is the Wako Autokit LP(A) Calibrator intended for?

  The Wako Autokit LP(A) Calibrator is specifically intended for use with the COBAS BIO analyzer system. This compatibility ensures seamless integration into existing laboratory workflows, allowing clinicians to maintain accurate and standardized LDL cholesterol measurements. Always verify system compatibility before use to avoid operational issues.

• Are there any special storage requirements for the Wako Autokit LP(A) Calibrator?

  While the Wako Autokit LP(A) Calibrator follows standard laboratory protocols for reagent controls, specific storage instructions are typically provided in the accompanying documentation. Generally, reagents like this should be stored in a clean, dry environment away from direct light and extreme temperatures. Always refer to the manufacturer’s guidelines to preserve the calibrator’s integrity and performance until use.

• What regulatory pathway does the Wako Autokit LP(A) Calibrator follow?

  The Wako Autokit LP(A) Calibrator has been cleared by the FDA under the 510(k) pathway (K001933) as a Class II medical device under special controls. This classification reflects its role in immunology diagnostics, where precision and reliability are critical. The device adheres to regulatory requirements to ensure safety, effectiveness, and compliance with immunology assay standards in clinical laboratories.