Abbott Anti-Delta Diagnostic Kit (RIA)
by Abbott Laboratories PMA
Withdrawn
PMA P850062
Overview
The Abbott Anti-Delta Diagnostic Kit (RIA) is a Hepatitis Delta Serological Reagents device classified as a Class III medical device under FDA regulations. It is designed for the qualitative detection of antibodies to the Hepatitis Delta virus (anti-Delta) in human serum or plasma using a radioimmunoassay (RIA) technique.
This kit is intended for use in clinical microbiology laboratories and requires professional handling. Supplied as a single-use diagnostic reagent, it is not sterile and must be stored under controlled conditions as specified in the accompanying instructions. The device holds an FDA Premarket Approval (PMA) under PMA number P850062, with subsequent supplements, and is regulated under product code LQI for microbiology applications.
Regulatory status
Withdrawn since 1 Jul 1986. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP850062 | Date1 Jul 1986 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Generic Name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- PMA Number
- FDA Product Code
- LQI
- Device Class
- Class III
- Advisory Committee
- Microbiology
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the Abbott Anti-Delta Diagnostic Kit (RIA) used for in a clinical setting?
The Abbott Anti-Delta Diagnostic Kit (RIA) is specifically designed for the qualitative detection of antibodies to the Hepatitis Delta virus (anti-Delta) in human serum or plasma. It uses a radioimmunoassay (RIA) technique to identify these antibodies, helping clinicians assess Hepatitis Delta virus infection status in patients. This test is intended for use exclusively in clinical microbiology laboratories by trained professionals.
Is this diagnostic kit single-use or reusable, and what does that mean for handling?
The Abbott Anti-Delta Diagnostic Kit (RIA) is supplied as a single-use diagnostic reagent. This means each kit is intended for one-time use only and cannot be reused after opening or partial consumption. Proper handling and disposal procedures must be followed to ensure accuracy of results and compliance with safety protocols, as reuse could compromise test reliability and introduce contamination risks.
How should the Abbott Anti-Delta Diagnostic Kit (RIA) be stored, and why is this important?
The kit must be stored under controlled conditions as outlined in the accompanying instructions. While the data does not specify exact storage parameters (like temperature), controlled conditions typically mean protecting it from extreme temperatures, light, and moisture. This is important because improper storage can degrade reagents, leading to inaccurate test results or rendering the kit unusable, which could impact diagnostic reliability.
What regulatory pathway does the Abbott Anti-Delta Diagnostic Kit (RIA) follow, and what does that mean for its use?
The kit holds an FDA Premarket Approval (PMA) under PMA number P850062, which is the highest level of regulatory clearance for medical devices in the U.S. This approval ensures the device has been thoroughly evaluated for safety and effectiveness before being marketed. Clinicians and laboratories can rely on this approval as evidence that the kit meets stringent regulatory standards for detecting anti-Delta antibodies in serum or plasma.
What type of laboratory setting is this kit intended for, and why is professional handling required?
The kit is explicitly intended for use in clinical microbiology laboratories, where trained professionals can perform the radioimmunoassay (RIA) technique with precision. Professional handling is required because the RIA method involves radioactive materials and complex procedural steps that demand expertise to avoid errors, ensure accurate results, and maintain safety standards for both personnel and patients.