QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Contr…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152013 FDA 510(k)
- FDA Product Code
- LSW 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 dsDNA is an Anti-DNA Antibody, Antigen, and Control for in vitro diagnostic use, designed to measure serum levels of anti-double-stranded DNA antibodies. This assay supports the detection and quantification of autoantibodies associated with autoimmune diseases, particularly in immunology testing.
The system comprises ready-to-use calibrators and controls, supplied as prediluted reagents in barcode-labeled tubes (0.7 mL volume). Manufactured from human serum containing high-titer anti-dsDNA antibodies, these components are intended for use with automated immunoassay platforms. Authorized under FDA 510(k) clearance (K152013) and classified as an IVD Directive (IVDD) device, compliance is ensured through regulatory submissions to the U.S. Food and Drug Administration and European Union standards.
Frequently asked questions
What is the QUANTA Flash dsDNA used for in clinical testing?
The QUANTA Flash dsDNA is designed to measure serum levels of anti-double-stranded DNA (dsDNA) antibodies, which are autoantibodies linked to autoimmune diseases. It supports detection and quantification of these antibodies in immunology testing, helping clinicians monitor conditions like systemic lupus erythematosus (SLE).
How are the QUANTA Flash dsDNA calibrators and controls supplied, and what form do they take?
The calibrators and controls come as prediluted reagents in barcode-labeled tubes, each containing 0.7 mL of human serum with high-titer anti-dsDNA antibodies. They are ready-to-use and optimized for automated immunoassay platforms, ensuring consistency and ease of integration into laboratory workflows.
Are the QUANTA Flash dsDNA components single-use or reusable, and how should they be stored?
The QUANTA Flash dsDNA calibrators and controls are intended for single-use only, as they are prediluted reagents designed for one-time application in testing. Storage instructions are not explicitly detailed in the provided data, but typical practice for serum-based reagents suggests refrigeration (2–8°C) until use, with protection from light and contamination.
What regulatory pathways does the QUANTA Flash dsDNA follow in the U.S. and Europe?
In the U.S., the device received FDA clearance through a traditional 510(k) pathway (K152013), classified as substantially equivalent under the Immunology advisory committee. It also complies with the European Union’s In Vitro Diagnostic Device Directive (IVDD), ensuring adherence to both U.S. and EU regulatory standards for diagnostic accuracy and safety.
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. Sources consulted: QUANTA Flash (R) dsDNA Calibrators | Werfen North America, QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash ..., DEVICE: QUANTA Flash® dsDNA Calibrators (08426950601913), QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash ...
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 | K152013 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K152013 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 26, 2026