Parvovirus B19 IgG Enzyme Immunoassay
FDA PMAClass III (US FDA PMA)
by Diasorin
Identity
- Trade Name
- BIOTRIN PARVOVIRUS B19 IGG FDA PMA
- Generic Name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG FDA PMA
Identifiers
- PMA Number
- P970054 FDA PMA
- FDA Product Code
- MYL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Parvovirus B19 IgG Enzyme Immunoassay is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to parvovirus B19 (B19V) in human serum, lithium heparin plasma, EDTA plasma, and citrated plasma. It aids in determining serological status for past, recent, or current B19V infection and supports diagnostic evaluation for fifth disease (erythema infectiosum).
This device is supplied as a diagnostic test kit and is intended for laboratory use. It requires no sterilisation as it is not implanted or invasive, and its single-use nature ensures sample-specific accuracy. The assay is classified as a Class III medical device under FDA regulations, with approval under PMA number P970054. Storage and handling follow standard laboratory protocols for immunoassays.
Frequently asked questions
What types of patient samples can be tested with the Parvovirus B19 IgG Enzyme Immunoassay, and why is this important for clinical use?
The assay is designed to work with human serum, lithium heparin plasma, EDTA plasma, and citrated plasma. This flexibility is important because it allows clinicians to use the sample type most readily available in their laboratory, whether from a routine blood draw or a specialized collection method. The ability to test multiple sample types ensures broader applicability for diagnosing past, recent, or current parvovirus B19 infections, including fifth disease, without requiring additional patient collections.
Is this test intended for single-use only, and if so, why does that matter for laboratory workflows?
Yes, the Parvovirus B19 IgG Enzyme Immunoassay is intended for single-use only. This design ensures that each test result is specific to the patient sample being analyzed, eliminating cross-contamination risks and maintaining accuracy. For laboratories, this means no reprocessing or reuse is required, simplifying inventory management and reducing the potential for errors associated with multi-use testing.
How should the test kit be stored, and what considerations should laboratories keep in mind beyond standard immunoassay protocols?
While the device data does not specify exact storage conditions, as a standard enzyme-linked immunosorbent assay (ELISA), it should be stored according to the manufacturer’s instructions (likely refrigerated or at room temperature, as per typical immunoassay guidelines). Laboratories should ensure the kit remains protected from light, moisture, and extreme temperatures, as these factors can degrade the assay reagents. Adhering to these protocols is critical to maintaining the assay’s sensitivity and specificity for detecting IgG antibodies to parvovirus B19.
What is the primary clinical purpose of this test, and how does it complement other diagnostic tools for parvovirus B19?
The primary purpose of the Parvovirus B19 IgG Enzyme Immunoassay is to qualitatively detect IgG antibodies, helping clinicians determine a patient’s serological status for past, recent, or current parvovirus B19 infection. When used alongside the Parvovirus B19 IgM Enzyme Immunoassay (not provided here but implied in the data), it provides a more comprehensive diagnostic picture—particularly for women of childbearing age—by distinguishing between active and resolved infections. This aids in assessing fetal infection risk and diagnosing conditions like fifth disease (erythema infectiosum).
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 | P970054 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diasorin
Sources (1)
- FDA PMA P970054 23 fields · synced Sep 18, 2026