Identifiers
- 510(k) Number
- K183571 FDA 510(k)
- FDA Product Code
- LJO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3175 FDA 510(k)
- Regulation Number
- 866.3175 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Capture-CMV is an in vitro qualitative solid phase red cell adherence test system classified as an Antigen, IHA, Cytomegalovirus (FDA Product Code: LJO). It is designed to detect IgG and IgM antibodies to cytomegalovirus (CMV) in human serum or plasma, aiding in the identification of serological evidence of prior CMV infection.
This device is intended for laboratory use in microbiology settings and is supplied as a single-use diagnostic kit. It requires human serum or plasma samples and adheres to standard in vitro testing protocols. The system is FDA-cleared under the 510(k) pathway (K183571) and falls under Class II regulatory classification, ensuring compliance with microbiological testing standards.
Frequently asked questions
What is the Capture-CMV used for?
The Capture-CMV is an in vitro diagnostic test designed to detect IgG and IgM antibodies to cytomegalovirus (CMV) in human serum or plasma. It helps identify serological evidence of prior CMV infection, which is useful in microbiology laboratories for patient screening and diagnostic purposes.
How is the Capture-CMV supplied?
The Capture-CMV is supplied as a single-use diagnostic kit, meaning each kit is intended for one-time use with a single test. This ensures consistency and reduces the risk of cross-contamination between samples.
Is the Capture-CMV sterile?
The device is intended for laboratory use and is designed as a single-use diagnostic kit. While sterility is not explicitly stated in the provided data, the nature of in vitro diagnostic tests like this typically requires adherence to aseptic handling practices to prevent contamination during testing.
Can the Capture-CMV test be reused?
No, the Capture-CMV is explicitly supplied as a single-use diagnostic kit. Reusing components could compromise test accuracy and introduce contamination risks, which is why it is designed for one-time use per sample.
What sample types does the Capture-CMV require?
The Capture-CMV requires human serum or plasma samples for testing. These sample types are standard for detecting antibodies in in vitro diagnostic assays, ensuring reliable detection of IgG and IgM antibodies to CMV.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Capture CMV, Immucor, Inc. - U.S. Food and Drug Administration, PDF Capture-CMV® - Eurofins Scientific, Capture-CMV (K183571) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183571 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA 510(k) K183571 24 fields · synced Oct 1, 2026