Quanta Flash Ro52, Quanta Flash Ro52 Calibrators, And Quanta Flash Ro52 Controls
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141655 FDA 510(k)
- FDA Product Code
- OBE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quanta Flash RO52 is an immunoassay system for the qualitative detection of anti-SSA/Ro (52 kDa) autoantibodies in human serum or plasma. Classified as an Anti-SSA/Ro (52 kDa) Autoantibodies test under the FDA’s device nomenclature, it aids in the immunologic evaluation of patients suspected of autoimmune diseases, such as systemic lupus erythematosus or Sjogren’s syndrome.
The Quanta Flash RO52 is supplied as a combination of test devices, calibrators, and controls for in vitro diagnostic use. It is intended for single-use and requires no special handling beyond standard laboratory procedures. The system is authorized under FDA 510(k) clearance (K141655) and complies with the In Vitro Diagnostic Device Directive (IVDD). Storage and handling follow manufacturer guidelines to maintain accuracy and reliability.
Frequently asked questions
What types of samples can the Quanta Flash RO52 test, and how is it intended to be used in clinical settings?
The Quanta Flash RO52 is designed for the qualitative detection of anti-SSA/Ro (52 kDa) autoantibodies in human serum or plasma only. It aids in the immunologic evaluation of patients suspected of autoimmune diseases like systemic lupus erythematosus or Sjogren’s syndrome by providing a qualitative result. The system is intended for in vitro diagnostic use in standard laboratory settings, requiring no specialized handling beyond routine procedures.
Is the Quanta Flash RO52 system single-use, or can components be reused?
The Quanta Flash RO52 is explicitly intended for single-use only. This includes the test devices, calibrators, and controls, which should not be reused to ensure accuracy and reliability. The manufacturer’s guidelines emphasize standard laboratory procedures, which inherently support single-use protocols for diagnostic assays.
What regulatory pathways has the Quanta Flash RO52 followed, and what does this mean for its use in clinical practice?
The Quanta Flash RO52 has undergone FDA 510(k) clearance (K141655) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means the device has been evaluated for substantial equivalence to a predicate device and meets EU regulatory standards for safety and performance. Clinically, this indicates the system has been reviewed for its intended use in detecting anti-SSA/Ro autoantibodies, ensuring it meets established benchmarks for diagnostic accuracy.
How should the Quanta Flash RO52 system be stored, and are there any special considerations for maintaining its integrity?
Storage and handling of the Quanta Flash RO52 follow the manufacturer’s guidelines to preserve accuracy and reliability. While specific storage conditions (e.g., temperature, light exposure) aren’t detailed here, standard laboratory practices for immunoassay systems—such as refrigeration or protection from contamination—are implied. The system is not labeled as requiring special handling beyond typical in vitro diagnostic procedures, so adherence to general lab protocols is recommended.
Are calibrators and controls included with the Quanta Flash RO52, and what role do they play in the testing process?
Yes, the Quanta Flash RO52 is supplied as a combination of test devices, calibrators, and controls, all intended for in vitro diagnostic use. Calibrators ensure measurement consistency across batches, while controls (positive and negative) validate the assay’s performance, confirming the system’s accuracy and reliability for each test run. These components are essential for maintaining the integrity of qualitative results in autoimmune disease evaluations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141655 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K141655 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 24, 2026