Indirect Fluorescent-Antibody Test for Gonorrhea (IFA-GC)
by Aerojet Medical and Biological Systems
PMA N17578
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N17578
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN17578 | Date28 May 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- PMA Number
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Indirect Fluorescent-Antibody Test for Gonorrhea (IFA-GC) is a diagnostic assay classified under indirect immunofluorescence techniques. It detects gonorrhea by identifying antibodies in patient samples through a fluorescent marker, enabling visual confirmation under a microscope. This method relies on two antibodies—one conjugated to a fluorescent dye and another specific to gonorrhea antigens—to amplify detection sensitivity. The test is designed for laboratory use in microbiological analysis of infectious disease specimens.
This test is supplied as a kit for in vitro diagnostic use and requires laboratory processing. It is not sterile for direct patient administration but is intended for use in controlled clinical or research settings. The device carries an FDA Premarket Approval (PMA) under PMA Number N17578, authorized for microbiological testing. Storage and handling must comply with standard laboratory protocols for immunofluorescence assays, including protection from light and temperature fluctuations.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Indirect Fluorescent-Antibody Test for Gonorrhea (IFA-GC) and how does it work in a clinical setting?
The IFA-GC is designed for laboratory-based microbiological testing to detect gonorrhea by identifying gonorrhea-specific antibodies in patient samples. It uses an indirect immunofluorescence technique: one antibody is tagged with a fluorescent dye, while another antibody binds to gonorrhea antigens in the sample. When viewed under a microscope, the fluorescent marker highlights the presence of these antibodies, confirming infection. This method is sensitive and relies on controlled laboratory processing.
Is the IFA-GC kit sterile, and if not, what precautions should be taken during use?
The IFA-GC kit is not sterile for direct patient administration, as it is intended exclusively for laboratory use. Since it involves handling infectious disease specimens, standard laboratory biosafety protocols must be followed, including proper personal protective equipment (PPE), decontamination of surfaces, and adherence to local infection control guidelines. The kit itself does not require sterile handling beyond typical immunofluorescence assay procedures.
How should the IFA-GC kit be stored, and what environmental conditions must be maintained?
The kit must be stored according to standard laboratory protocols for immunofluorescence assays, which generally include protection from direct light and temperature fluctuations. Since immunofluorescence relies on sensitive reagents, it’s critical to follow manufacturer instructions for shelf-life and storage conditions (e.g., refrigeration if specified). Avoid exposure to extreme heat, cold, or prolonged sunlight, as these can degrade the fluorescent markers or antibodies.
What regulatory pathway does the IFA-GC follow, and what does this mean for its use in clinical or research settings?
The IFA-GC holds an FDA Premarket Approval (PMA) under PMA Number N17578, meaning it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in microbiological testing. This approval allows its use in clinical or research laboratories for diagnosing gonorrhea via indirect immunofluorescence. The PMA status does not imply direct patient administration but confirms the assay’s validity for laboratory diagnostics.