Oncor B/T Gene Rearrangement Test
by Oncor, Inc.
PMA P880016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880016 | Date10 Oct 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- DNA-probe, b and t lymphocyte
- PMA Number
- FDA Product Code
- MAM
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Oncor B/T Gene Rearrangement Test is a DNA-probe device designed for the detection of B and T lymphocyte gene rearrangements. It is classified under the nomenclature for hematological diagnostics and utilises molecular techniques to identify specific genetic markers associated with B and T cell lineages, aiding in the diagnosis and monitoring of hematologic conditions.
This test is supplied as an in vitro diagnostic device and is intended for laboratory use only. It requires specialized handling, including sterile preparation and adherence to manufacturer-provided protocols. The device is authorised under FDA PMA (P880016) and falls under device class II (regulation number 864.5220). Storage and usage must comply with regulatory guidelines to ensure accuracy and reliability of results.
Questions
AI-generated answers, 18 Sep 2026
What specific medical conditions can the ONCOR B/T Gene Rearrangement Test help diagnose or monitor?
The ONCOR B/T Gene Rearrangement Test detects B and T lymphocyte gene rearrangements, which are genetic markers associated with B and T cell lineages. This aids in diagnosing and monitoring hematologic conditions, such as certain types of leukemia or lymphoma, where abnormal lymphocyte proliferation may occur. The test is designed to support laboratory-based investigations into these conditions by identifying specific genetic rearrangements linked to abnormal cell growth.
Is the ONCOR B/T Gene Rearrangement Test intended for use outside of a clinical laboratory setting?
No, the ONCOR B/T Gene Rearrangement Test is explicitly labeled for laboratory use only. It requires specialized handling, including sterile preparation and adherence to manufacturer protocols, which are typically performed in controlled laboratory environments. Point-of-care or non-laboratory settings lack the necessary infrastructure for accurate molecular testing and result interpretation.
How is the ONCOR B/T Gene Rearrangement Test supplied, and what storage requirements apply?
The test is supplied as an in vitro diagnostic device, meaning it comes pre-packaged for laboratory use. While the exact packaging details are not specified, molecular diagnostics like this typically require refrigeration or frozen storage to maintain probe integrity. The manufacturer’s instructions (not provided here) would outline precise storage conditions, but compliance with regulatory guidelines—such as avoiding temperature fluctuations—is critical to ensure the test’s accuracy and reliability.
Can the ONCOR B/T Gene Rearrangement Test be reused, or is it designed for single-use?
The test is designed for single-use only, as implied by its classification as an in vitro diagnostic device requiring sterile preparation. Molecular probes and reagents in such tests are not intended for repeated use due to potential contamination risks and degradation over time. Reuse could compromise test validity and introduce errors in genetic marker detection.