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Coccidioides (Cocci) Antigen, Latex Agglutination

FDA 510(k)

Class II (US FDA 510(k))

510(k) K791381

by Immuno-Mycologics, Inc.

Identifiers

510(k) Number
K791381 FDA 510(k)
FDA Product Code
GMG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3135 FDA 510(k)
Regulation Number
866.3135 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Coccidioides (Cocci) Antigen, Latex Agglutination is a diagnostic test classified as an Antigen, Latex Agglutination device for detecting Coccidioides immitis. It functions through latex agglutination, a serological method used to identify antigens in patient samples, aiding in the diagnosis of coccidioidomycosis, a fungal infection caused by Coccidioides species. The test relies on the principle of agglutination between latex particles coated with specific antibodies and the target antigen in a sample, producing a visible reaction when the antigen is present.

This device is supplied as a Class II microbiology diagnostic tool, regulated under 21 CFR 866.3135 and assigned product code GMG. It is intended for in vitro use in clinical laboratories, where trained personnel perform the test on serum or cerebrospinal fluid samples. The device is single-use, with no specified sterility requirements beyond standard laboratory practices. No MRI safety or reusable components are indicated in the specifications, and storage conditions are not detailed beyond typical diagnostic reagent handling. The device holds FDA 510(k) clearance (K791381) under the Traditional pathway, granted in 1979.

Frequently asked questions

What is the Coccidioides (Cocci) Latex Agglutination Test used for?

This test detects Coccidioides immitis antigens in patient samples using latex agglutination, helping diagnose coccidioidomycosis—a fungal infection caused by Coccidioides species. It’s designed for in vitro use in clinical laboratories to analyze serum or cerebrospinal fluid samples for visible antigen-antibody reactions.

How is the Coccidioides (Cocci) Latex Agglutination Test supplied?

The test is supplied as a single-use diagnostic reagent kit for in vitro laboratory testing. It requires trained personnel to perform the latex agglutination procedure, following standard microbiology protocols. No additional sterile packaging beyond typical reagent handling is specified.

Is the Coccidioides (Cocci) Latex Agglutination Test reusable?

No, this device is intended for single-use only. Each kit is designed for one test procedure, and reuse is not supported or recommended by the manufacturer to maintain accuracy and prevent contamination.

What sample types can be tested with the Coccidioides (Cocci) Latex Agglutination Test?

The test is approved for use with serum and cerebrospinal fluid (CSF) samples. These sample types are processed in clinical laboratories to identify Coccidioides immitis antigens through the latex agglutination reaction.

How should the Coccidioides (Cocci) Latex Agglutination Test be stored?

While specific storage conditions aren’t detailed, the test should be handled according to standard diagnostic reagent protocols. This includes protecting it from extreme temperatures, moisture, and contamination, as with other latex agglutination devices.

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: COCCIDIODES (COCCI) (K791381) — FDA 510 (k) | Innolitics, K791381 FDA 510 (k) - COCCIDIODES (COCCI), COCCIDIODES (COCCI) 510 (k) K791381 - FDA.report, Clinical Laboratory Utility of a Humanized Antibody in Commercially ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immuno-Mycologics, Inc.

Sources (1)

  • FDA 510(k) K791381 24 fields · synced Oct 1, 2026