MicroTrak CMV Culture Confirmation Test
by Syva Co. 510(k)
Active
510(k) K880290
Overview
The MicroTrak CMV Culture Confirmation Test is an in vitro diagnostic device classified as an Antigen, Confirmatory (Cf) for detecting cytomegalovirus (CMV). It is designed to confirm the presence of CMV in clinical specimens by identifying viral antigens, aiding in the diagnosis of CMV infections. This test is part of the broader category of microbiology assays and is intended for use in laboratory settings to validate culture results, ensuring accurate identification of CMV.
The test is supplied as a kit for professional laboratory use and is intended for single-use only. It requires sterile handling and is regulated under FDA 510(k) clearance (K880290) as a Class II device, adhering to microbiology standards. Storage conditions and shelf life are not specified in the provided data. The product code GQH and registration numbers (e.g., 2242436) further identify its regulatory classification under 21 CFR 866.3175 for antigen detection assays.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880290 | Date19 Apr 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GQH
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3175
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the MicroTrak CMV Culture Confirmation Test used for?
This test is designed to confirm the presence of cytomegalovirus (CMV) in clinical specimens by detecting viral antigens. It serves as a confirmatory step after culture results, helping laboratories ensure accurate identification of CMV infections in microbiology settings.
How is the MicroTrak CMV Culture Confirmation Test supplied and intended for use?
The test is supplied as a professional laboratory kit, intended exclusively for single-use. It requires sterile handling to maintain accuracy and reliability in diagnostic workflows, adhering to microbiology best practices.
Is the test sterile and reusable, or single-use?
The MicroTrak CMV Culture Confirmation Test is designed for single-use only. Sterility is critical for its performance, so each kit must be handled under aseptic conditions to prevent contamination and ensure valid results.
What regulatory pathway does this device follow?
The test is cleared by the FDA under the 510(k) pathway (K880290) as a Class II device, classified under 21 CFR 866.3175 for antigen detection assays. This clearance confirms its compliance with microbiology standards for confirmatory diagnostic use.
What distinguishes this test from other CMV diagnostic tools?
Unlike general screening tests, the MicroTrak CMV Culture Confirmation Test specifically validates culture results by identifying viral antigens, providing a confirmatory step to reduce false positives or negatives in clinical specimens. This makes it a targeted tool for accurate CMV diagnosis in laboratory settings.