Cytomegalovirus Antibody Screen
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K910003 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)
Cytomegalovirus Antibody Screen is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. It is classified under regulation number 866.3175 with product code LJO and device class 2.
The device received FDA 510(k) clearance K910003 on March 20, 1991, and is substantially equivalent to a predicate device. It is manufactured by Immucor, Inc. and intended for use in microbiology laboratory settings.
Frequently asked questions
What is the Cytomegalovirus Antibody Screen used for?
The Cytomegalovirus Antibody Screen is used to detect antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. It is an in vitro qualitative solid phase red cell adherence test system intended for use in microbiology laboratory settings to aid in assessing CMV exposure or infection status.
How is the Cytomegalovirus Antibody Screen supplied and what is its format?
The device is supplied as an in vitro qualitative solid phase red cell adherence test system. It is designed for laboratory use with human serum or plasma samples, utilizing a solid phase methodology to detect CMV-specific antibodies through red cell adherence patterns.
Is the Cytomegalovirus Antibody Screen a single-use or reusable device?
The Cytomegalovirus Antibody Screen is intended for single-use in each test run. As an in vitro diagnostic test system, it is designed for one-time application per patient sample to ensure test integrity and prevent cross-contamination, consistent with standard clinical laboratory practices for reagent-based assays.
What regulatory pathway was used for the Cytomegalovirus Antibody Screen?
The device received FDA 510(k) clearance under submission K910003 on March 20, 1991, and was determined to be substantially equivalent to a predicate device. This traditional 510(k) pathway confirms its safety and effectiveness based on comparison to legally marketed devices.
What are the key identifiers for the Cytomegalovirus Antibody Screen?
The device is identified by the name Cytomegalovirus Antibody Screen, manufactured by Immucor, Inc., with product code LJO and regulation number 866.3175. It is classified as a class 2 device under the FDA product code LJO, with clearance number K910003.
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: CYTOMEGALOVIRUS ANTIBODY SCREEN (K910003) — FDA 510 (k) | Innolitics, CYTOMEGALOVIRUS ANTIBODY SCREEN 510(k) K910003 - FDA.report, PDF Capture CMV, Immucor, Inc. - U.S. Food and Drug Administration, PDF Capture-CMV® - Eurofins Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910003 | Class II | Active |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA 510(k) K910003 24 fields · synced Sep 25, 2026