FilmArray Global Fever Panel External Control Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202382 FDA 510(k)
- FDA Product Code
- PMN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3920 FDA 510(k)
- Regulation Number
- 866.3920 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FilmArray Global Fever Panel External Control Kit is an assayed external control material for microbiology nucleic acid amplification (NAT) assays. It is designed to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of specific pathogens.
The kit includes positive and negative external controls provided in FilmArray Control Injection Vial format. The positive control contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the BioFire Global Fever Special Pathogens Panel, while the negative control contains no DNA and is non-reactive. It is intended for use with the BioFire Global Fever Panel pouch to ensure accurate results for pathogen targets only.
Frequently asked questions
What is the FilmArray Global Fever Panel External Control Kit used for?
It is used to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of specific pathogens when used with the BioFire Global Fever Panel pouch. The positive control contains dried synthetic DNA segments to assess each assay, while the negative control contains no DNA and is non-reactive.
How is the FilmArray Global Fever Panel External Control Kit supplied?
The kit includes positive and negative external controls provided in FilmArray Control Injection Vial format. The positive control contains dried synthetic DNA segments in buffer and stabilizer, and the negative control contains no DNA and is non-reactive.
Is the FilmArray Global Fever Panel External Control Kit intended for single-use or reuse?
The kit is intended for single-use only, as it consists of external control materials designed for one-time use to monitor assay performance and ensure accurate results for pathogen targets with the BioFire Global Fever Panel pouch.
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: PDF BIOFIRE ™SHIELD Control Kit, PDF BIOFIRE SHIELD Control Kit, PDF BioFire Global Fever Panel Instructions - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202382 | Class II | Active |
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Manufacturer
- Manufacturer
- BioFire Defense, LLC
Sources (1)
- FDA 510(k) K202382 24 fields · synced Sep 24, 2026