Corab Hepatitis B Test
by Abbott Laboratories PMA
Active
PMA P780016
Overview
The Corab Hepatitis B Test is an in vitro diagnostic device classified as a Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen). It is designed to detect the presence of hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and antibody to hepatitis B core antigen (anti-HBc) in human serum or plasma, aiding in the diagnosis and monitoring of hepatitis B virus infection.
This device is supplied as a single-use diagnostic kit and is intended for use in clinical microbiology laboratories. It requires FDA_PMA authorization (PMA Number: P780016) and is regulated under the 866.3172 classification. The test is not MRI-compatible and must be stored and handled according to manufacturer guidelines to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP780016 | Date11 Apr 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Corab
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- PMA Number
- FDA Product Code
- LOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3172
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Other devices from Abbott Laboratories
Questions
What specific markers does the Corab Hepatitis B Test detect in patient samples, and how does this help in diagnosing hepatitis B infection?
The Corab Hepatitis B Test detects hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and antibody to hepatitis B core antigen (anti-HBc) in human serum or plasma. These markers aid in diagnosing active infection, assessing viral replication (via HBeAg), and identifying past or ongoing exposure to the hepatitis B virus, respectively. This comprehensive detection helps clinicians determine infection status, monitor disease progression, and guide treatment decisions.
Is the Corab Hepatitis B Test intended for use in all clinical settings, or is it specifically designed for certain laboratory environments?
The Corab Hepatitis B Test is supplied as a single-use diagnostic kit and is explicitly intended for use in clinical microbiology laboratories. While it is not restricted to specific lab types, its design assumes the infrastructure, training, and protocols typical of microbiology labs to ensure accurate results and proper handling of infectious samples.
How is the Corab Hepatitis B Test supplied, and does it require any special handling or storage conditions?
The Corab Hepatitis B Test is supplied as a single-use diagnostic kit, meaning each kit is intended for one test procedure. While the exact storage conditions are manufacturer-specific, the device data notes it must be stored and handled according to manufacturer guidelines to maintain accuracy and reliability. This likely includes protection from extreme temperatures, light, or contamination, though precise details would require consulting Abbott’s instructions.
What regulatory pathway was followed for the Corab Hepatitis B Test, and what does this mean for its use in clinical practice?
The Corab Hepatitis B Test was authorized through the FDA Premarket Approval (PMA) process, with PMA Number P780016. This pathway is typically used for higher-risk devices, ensuring rigorous evaluation of safety and effectiveness before market authorization. Clinically, this means the test has undergone thorough validation by the FDA, though ongoing compliance with manufacturer protocols remains essential for accurate results.