Abbott HBE Diagnostic Kit
by Abbott Laboratories PMA
Withdrawn
PMA P790025
Overview
This device is a Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), classified under Class II medical devices. It is designed for the detection of hepatitis B virus markers in serum or plasma samples, aiding in the diagnosis of hepatitis B infection. The kit provides qualitative results for B antigen, B surface antigen, and Be antigen, which are critical indicators of viral replication and infection status. Its use is governed by regulatory standards for microbiological testing, ensuring accuracy and reliability in clinical settings.
The Abbott HBE Diagnostic Kit is supplied as a diagnostic reagent kit for in vitro use in clinical laboratories. It is intended for single-use only and requires no special storage conditions beyond refrigeration, as specified in its regulatory submission. The device is approved under FDA Premarket Approval (PMA) with PMA number P790025, filed under product code LOM. Compliance with FDA regulations ensures its suitability for microbiological testing in accredited laboratories, adhering to strict sterility and performance standards.
Regulatory status
Withdrawn since 15 Jul 1980. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP790025 | Date15 Jul 1980 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- PMA Number
- FDA Product Code
- LOM
- Regulation
- 21 CFR Part 866.3172
- Advisory Committee
- Microbiology
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What clinical markers does the Abbott HBE Diagnostic Kit detect, and why are these important for diagnosing hepatitis B infection?
The Abbott HBE Diagnostic Kit detects three key markers of hepatitis B infection: B antigen (HBeAg), B surface antigen (HBsAg), and Be antigen (HBeAg). HBsAg indicates the presence of the hepatitis B virus, while HBeAg signals active viral replication, which is critical for assessing infectiousness and guiding treatment decisions. These markers help clinicians determine infection status, disease progression, and whether a patient is contagious.
Is the Abbott HBE Diagnostic Kit intended for reuse, or is it designed for single-use only? How should it be stored?
The kit is explicitly designed for single-use only, meaning each test requires a new kit. Storage is straightforward—no special conditions are required beyond standard refrigeration, ensuring stability and reliability for clinical use in laboratories.
What regulatory pathway was followed for the Abbott HBE Diagnostic Kit, and what does this mean for its use in clinical settings?
The kit was approved through the FDA Premarket Approval (PMA) process under PMA number P790025, filed under product code LOM. This pathway ensures the device meets rigorous standards for safety, effectiveness, and performance in microbiological testing. Clinicians can rely on its compliance with FDA regulations, including sterility and accuracy requirements, when diagnosing hepatitis B in accredited laboratories.
Are there multiple versions or sizes of the Abbott HBE Diagnostic Kit, or is it supplied as a single standardized kit?
The data indicates the kit is supplied as a single standardized diagnostic reagent kit for in vitro use in clinical laboratories. While multiple FEI numbers and registration numbers are listed, these appear to be administrative identifiers (e.g., for tracking submissions or lot control) rather than distinct product variants. Clinicians should confirm with Abbott Laboratories if specific configurations or accessories are available for their workflow.