BION CMV-G Test System

• • Terminated Z-1478-2013 FDA Class III ·initiated 23 Jan 2013

  Affected products have a labeled expiration date of one year too long.

510(k) Number

K880679 ↗

FDA Product Code

GQH

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bion Borrelia Burgdorferi Antigen Substrate Slide

  Class II

  FDA 510(k) K901054 Active Cleared 5 Apr 1990

• Respiratory Syncytial Virus

  Class I

  FDA 510(k) K894623 Active Cleared 16 Oct 1989

• Bion Mumps-G Antibody Test System

  Class II

  FDA 510(k) K926066 Active Cleared 15 Jun 1993

• Bion Direct Identification Control Slide

  Class I

  FDA 510(k) K890616 Active Cleared 17 Feb 1989

• Mumps Virus

  Class I

  FDA 510(k) K894624 Active Cleared 16 Oct 1989

• Epstein-Barr Virus-Nuclear Antigen

  Class I

  FDA 510(k) K894626 Active Cleared 16 Oct 1989

See all devices from Bion Ent., Ltd. →

• What is the BION CMV-G Test System used for?

  The BION CMV-G Test System is an in vitro diagnostic device specifically designed to detect CMV (cytomegalovirus) antigens in clinical specimens. It aids clinicians in diagnosing CMV infections by providing rapid and reliable results in laboratory environments. This is particularly useful for identifying active viral replication, which helps guide patient management and treatment decisions.

• How is the BION CMV-G Test System supplied and intended for use?

  The system is supplied as a single-use device, meaning each test kit is intended for one-time use only. It is manufactured and packaged to ensure sterility, allowing for safe handling in laboratory settings. The design aligns with FDA-cleared standards (K880679, Product Code GQH), ensuring compliance with regulatory requirements for microbiological testing.

• Is the BION CMV-G Test System reusable or single-use?

  This test system is explicitly designed for single-use only. After use, the kit should be discarded to maintain sterility and prevent cross-contamination. The manufacturer’s packaging and instructions emphasize this to ensure accurate and safe diagnostic results while adhering to regulatory standards for in vitro diagnostic devices.

• How should the BION CMV-G Test System be stored?

  Storage instructions are detailed in the accompanying documentation provided by the manufacturer. Generally, in vitro diagnostic devices like this are stored in a clean, dry environment protected from extreme temperatures and direct sunlight. The sealed, sterile packaging should remain intact until use to preserve the device’s integrity and reliability. Always follow the manufacturer’s guidelines to avoid compromising test accuracy.

• What regulatory pathway does the BION CMV-G Test System follow?

  The BION CMV-G Test System follows the traditional 510(k) clearance pathway under the FDA, classified as a Class II device (Product Code GQH). This pathway ensures the device meets established performance standards for antigen tests in microbiology. The clearance (K880679) confirms its substantial equivalence to a predicate device, validating its safety and effectiveness for detecting CMV antigens in clinical specimens.