Serological Reagents
InVitro Diagnostic devices that include antigens and antisera utilized in serological assays to detect antibodies against viruses and other pathogens in serum samples (a clear, yellowish liquid that is derived from blood after the blood has clotted and the cellular components and clotting factors have been removed).
Adenovirus Serological Reagents
As per FDA IVD classification Adenovirus serological reagents are Class I medical devices and regulated under 21 CFR 866.3020. These reagents aid in detecting adenovirus antibodies or antigens, diagnosing diseases like Pharyngitis (Throat inflammation), Acute Respiratory Diseases (Bronchitis or pneumonia) and Conjunctivitis (Eye infections) etc.,
Regulation Number for Adenovirus serological reagents falls under 21 CFR 866.3020 and is classified as a Class 1 device.
- Antisera, Fluorescent, Adenovirus 1–33: GNY
- Antigens, Cf (Including Cf Control), Adenovirus 1–33: GOD
Intended Use
Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum.
Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases.
Device Descriptions
- Antisera, Fluorescent, Adenovirus 1–33 (GNY)
The D3 Fast Point L-DFA Kit uses murine monoclonal antibodies conjugated with fluorescein isothiocyanate (FITC) to detect adenoviruses in nasal and nasopharyngeal swabs.
These reagents rapidly identify adenovirus infections, providing crucial insights for timely medical intervention.
Antigens, Cf, Including Cf Control, Adenovirus 1–33 (GOD)
This device comprises:
- Sample Collector: Sterile tool with Dacron fleece for ocular fluid collection.
- Test Cassette: Protects the lateral flow assay strip for sample processing.
- Buffer Solution: Facilitates antigen extraction, debris filtration, and immune complex transport to test and control lines.
Key Requirements for 510k Submission
Manufacturers must submit comprehensive data, including:
- Device Description: Detailed explanation of components and mechanisms.
- Performance Testing: Validation of analytical and clinical performance.
- Risk Analysis: Ensures device safety under various conditions.
Performance Testing
1. Analytical Performance-Nonclinical
- Specificity
- Reproducibility
- Limit of Detection (LOD).
- Inclusivity
2. Clinical Performance testing:
- Sensitivity
- Specificity:
- Clinical Cut-off
3. Additional Testing:
- Interfering Substances
- Precision
- Cross reactivity
Labelling Requirements
FDA regulations mandate detailed and accurate labelling to ensure safe and effective device use. Labelling elements include declaration of the established name, quantity, proportion or concentration of each reactive ingredient, the quantity, proportion, concentration should be clearly mentioned.
Appropriate storage instructions adequate to protect the stability of the product. An expiration date should be mentioned. Name and place of business of manufacturer, packer, or distributor, lot or control number.
Stability Testing
To maintain integrity of Serological reagents throughout their lifecycle stability testing is crucial and includes Shelf-Life, Transport, Open-Bottle, and Accelerated Stability Testing.
Conclusion
Adenovirus serological reagents highlight the crucial role of in vitro diagnostic medical devices in modern healthcare. By facilitating quick and accurate diagnoses, these tools significantly contribute to improving patient outcomes, optimizing disease management, and enhancing public health.
With the development of fluorescent-labeled antisera and stringent performance testing protocols, these reagents emphasize the precision and reliability of IVDs.
As regulatory frameworks FDA 510k process set standards for quality and safety, serological reagents will remain essential in clinical diagnostics and epidemiological research.
Written By
Ms. Suman Mishra (M.Pharm) | Regulatorty Consultant, FDA Compliance | Medical Device