QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
FDA 510(k)Class II (US FDA 510(k))
by QIAGEN GmbH
Identifiers
- 510(k) Number
- K250080 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
- Models / Variants
- QIAstat-Dx Respiratory Panel Plus FDA 510(k)QIAstat-Dx Respiratory Panel Mini FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QIAstat-Dx Respiratory Panel Plus and QIAstat-Dx Respiratory Panel Mini are Multi-Target Respiratory Specimen Nucleic Acid Tests designed to detect SARS-CoV-2 and multiple other microbial agents. These in vitro diagnostic devices use nucleic acid amplification technology to identify pathogens associated with respiratory infections, enabling rapid and comprehensive syndromic testing. The panels are intended for use in clinical microbiology laboratories to aid in the diagnosis of respiratory illnesses by detecting a broad spectrum of viruses and bacteria in a single assay.
These devices are supplied as single-use kits for use with the QIAstat-Dx Analyzer 1.0, 2.0, or Rise systems. The QIAstat-Dx Respiratory Panel Mini targets five viral pathogens, while the Plus version extends coverage to 21 bacteria and viruses, including common respiratory pathogens. Both panels are regulated under FDA 510(k) clearance (K250080) and fall under Class II medical devices (regulation number 866.3981). They require proper storage and handling as specified in the manufacturer’s instructions to maintain test integrity and performance.
Frequently asked questions
What pathogens does the QIAstat-Dx Respiratory Panel Plus detect?
The QIAstat-Dx Respiratory Panel Plus detects 21 microbial agents, including viruses and bacteria linked to respiratory infections. This comprehensive panel covers common respiratory pathogens such as SARS-CoV-2, influenza A/B, respiratory syncytial virus (RSV), and others, enabling syndromic testing in a single assay. The Mini version targets five viral pathogens, making it suitable for focused testing when broader coverage isn’t required.
How is the QIAstat-Dx Respiratory Panel supplied and used?
The QIAstat-Dx Respiratory Panel Plus and Mini are supplied as single-use kits designed exclusively for use with the QIAstat-Dx Analyzer 1.0, 2.0, or Rise systems. Each kit contains all necessary reagents and consumables for one test, ensuring no cross-contamination between samples. The panels require processing on the specified analyzer systems to extract and amplify nucleic acids for pathogen detection.
Are these panels sterile and single-use?
Yes, both the QIAstat-Dx Respiratory Panel Plus and Mini are single-use kits, ensuring sterility and preventing carryover between tests. The design adheres to clinical laboratory standards for nucleic acid testing, where single-use consumables are critical to maintaining test integrity and minimizing contamination risks. Reuse is not permitted as it could compromise accuracy and safety.
What storage conditions are required for these panels?
The panels must be stored according to the manufacturer’s instructions to preserve their performance. Typically, this involves refrigeration at 2–8°C (36–46°F) and protection from light until use. Proper storage prevents degradation of nucleic acid amplification reagents and ensures reliable detection of pathogens. Always refer to the included instructions for specific handling and expiration details.
How does the QIAstat-Dx Respiratory Panel Plus differ from the Mini version?
The primary difference lies in the breadth of coverage: the Plus version detects 21 pathogens (viruses and bacteria), while the Mini version targets five viral pathogens. The Plus is ideal for laboratories needing broader syndromic testing, whereas the Mini offers a streamlined option for focused viral detection. Both use the same nucleic acid amplification technology and require the QIAstat-Dx Analyzer systems for operation.
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: QIAstat-Dx US - QIAGEN, QIAstat-Dx Respiratory Panel | Syndromic Testing | QIAGEN, PDF QIAstat-Dx® Respiratory Panels brochure - Cardinal Health, Qiagen N.V. - QIAGEN receives FDA clearance for QIAstat-Dx mini panel ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250080 | Class II | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA 510(k) K250080 24 fields · synced Oct 1, 2026