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CMV IGG Antibody Test (Indirect Fluorescent Test)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K893468

by Immuno Concepts Inc

Identifiers

510(k) Number
K893468 FDA 510(k)
FDA Product Code
LIN 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)

This device is an Antisera, Conjugated Fluorescent, Cytomegalovirus test, classified under product code LIN. It is an indirect fluorescent antibody test designed to detect immunoglobulin G (IgG) antibodies against cytomegalovirus (CMV) in human serum or plasma. The test relies on fluorescent labeling to identify antibody-antigen interactions, enabling qualitative assessment of CMV IgG serostatus in clinical microbiology applications.

The CMV IGG Antibody Test is supplied as a diagnostic reagent kit for in vitro use in clinical laboratories. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. The device is regulated under FDA 510(k) clearance (K893468) and falls under Class II special controls for microbiology applications. Storage and handling follow standard laboratory protocols for fluorescent antibody tests, with expiration dates and stability conditions specified by the manufacturer.

Frequently asked questions

What is the CMV IgG Antibody Test (Indirect Fluorescent) used for?

This test detects immunoglobulin G (IgG) antibodies against cytomegalovirus (CMV) in human serum or plasma. By using fluorescent labeling, it visually identifies antibody-antigen interactions to determine a patient’s CMV IgG serostatus, which helps clinicians assess past CMV infection or immunity in clinical microbiology settings.

How is the CMV IgG Antibody Test supplied and prepared for use?

The test is supplied as a diagnostic reagent kit designed for in vitro use in clinical laboratories. It comes pre-packaged and requires no additional sterilization beyond the manufacturer’s sealed packaging. Laboratories must follow the included instructions for reconstitution and handling, as the kit is intended for single-use only.

Is the CMV IgG Antibody Test sterile and reusable?

The test is supplied in sterile packaging as part of the kit, but it is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as fluorescent antibody tests may degrade with repeated exposure to light or handling.

What storage and handling requirements apply to this test?

Storage follows standard laboratory protocols for fluorescent antibody tests. The manufacturer specifies expiration dates and stability conditions (e.g., refrigeration or room temperature) in the kit documentation. Unopened kits should be stored according to these guidelines to maintain accuracy; opened reagents must be used promptly and discarded after single-use.

Does this test require any special regulatory approvals or clearances?

The CMV IgG Antibody Test holds FDA 510(k) clearance (K893468) under product code LIN, classified as a Class II device for microbiology applications. It is regulated under special controls for in vitro diagnostic tests, ensuring compliance with FDA standards for qualitative antibody detection.

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: K893468 FDA 510(k) - CMV IGG ANTIBODY TEST (INDIRECT FLUORES..., Cmv Igg Antibody Test (Indirect Fluorescent Test) (K893468) — Fda 510 ..., Cmv Igg Antibody Test (Indirect Fluorescent Test), PDF K893468 - Cmv Igg Antibody Test (Indirect Fluorescent Test), Leading Autoimmune Disease Diagnostic Solutions | Immuno Concepts

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immuno Concepts Inc
FDA Applicant
Immuno Concepts, Inc.

Sources (1)

  • FDA 510(k) K893468 24 fields · synced Oct 1, 2026