Identity
- Trade Name
- HA-IGMK AND ETI-HA-IGMK FDA PMA
- Generic Name
- Hepatitis a test (antibody and igm antibody) FDA PMA
Identifiers
- PMA Number
- P890014 FDA PMA
- FDA Product Code
- LOL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3310 FDA PMA
- Regulation Number
- 866.3310 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The HA-IGMK and ETI-HA-IGMK is a Hepatitis A Test (Antibody and IgM Antibody), classified as a Class II medical device under FDA regulations. It is designed to detect total anti-Hepatitis A virus antibodies and IgM antibodies in human serum or plasma, aiding in the diagnosis of Hepatitis A infection and distinguishing between acute and past exposure.
This device is supplied as an in vitro diagnostic reagent and is intended for single-use in clinical microbiology laboratories. It requires no special storage conditions beyond refrigeration (2–8°C) and is regulated under FDA PMA (Premarket Approval) with PMA number P890014. Compliance with 21 CFR 866.3310 ensures its use in microbiology settings for accurate serological testing.
Frequently asked questions
What clinical purpose does the HA-IGMK test serve in diagnosing Hepatitis A infections?
The HA-IGMK test detects both total anti-Hepatitis A virus antibodies and IgM antibodies in human serum or plasma. This helps clinicians differentiate between acute Hepatitis A infections (indicated by IgM antibodies) and past exposure (indicated by total antibodies), aiding in accurate diagnosis and patient management.
Is this device intended for reuse, or is it designed for single-use only?
The HA-IGMK is explicitly supplied as a single-use in vitro diagnostic reagent. It is not intended for reuse, ensuring patient safety and test accuracy by preventing cross-contamination or degradation of components.
What storage conditions are required for the HA-IGMK test, and can it be kept at room temperature?
The device requires refrigeration between 2–8°C and does not need any special storage conditions beyond this. It should not be stored at room temperature, as this could compromise its stability and performance.
How is the regulatory approval process for this device categorized, and what does that mean for its use?
The HA-IGMK is regulated under the FDA’s Premarket Approval (PMA) pathway, indicated by PMA number P890014. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use in clinical microbiology laboratories, specifically for serological testing of Hepatitis A antibodies.
Where and how would a laboratory typically use this test, given its classification and intended use?
This test is designed for use in clinical microbiology laboratories to detect Hepatitis A antibodies in human serum or plasma. Its classification as a Class II device under FDA regulations ensures it meets performance standards for accurate serological testing, helping clinicians diagnose infection status or past exposure to Hepatitis A.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P890014 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P890014 24 fields · synced Sep 18, 2026