Cepheid Xpert CT/NG Control Panel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190223 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 Cepheid Xpert CT/NG Control Panel is an assayed external control material for microbiology nucleic acid amplification (NAT) assays, designed to monitor the performance of the Cepheid Xpert CT/NG assay. It provides validated positive and negative controls for evaluating extraction, amplification, and detection processes in molecular diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae testing.
This single-use control panel is supplied as a ready-to-use kit containing six positive control swabs and six negative control swabs, formatted for compatibility with the Cepheid Xpert system. It is intended for use in clinical microbiology laboratories to verify assay integrity and troubleshoot instrument or reagent failures. The device is classified under FDA regulation 866.3920 and holds a 510(k) clearance (K190223) as a Class II medical device, with no third-party certification required.
Frequently asked questions
What is the Cepheid Xpert CT/NG Control Panel used for in a clinical lab setting?
The Cepheid Xpert CT/NG Control Panel is an assayed external control material designed specifically to monitor the performance of the Cepheid Xpert CT/NG assay. It helps verify the integrity of extraction, amplification, and detection processes for *Chlamydia trachomatis* and *Neisseria gonorrhoeae* testing, ensuring accurate results. It is also used for troubleshooting instrument or reagent failures in clinical microbiology labs.
How is the Cepheid Xpert CT/NG Control Panel supplied, and is it reusable?
The control panel is supplied as a single-use kit containing six positive control swabs and six negative control swabs, ready for immediate use with the Cepheid Xpert system. Since it is explicitly labeled as single-use, it cannot be reused after opening or use.
Are there different sizes or models available for the Cepheid Xpert CT/NG Control Panel?
The provided data does not specify multiple sizes or models for the Cepheid Xpert CT/NG Control Panel. It is described as a single kit format containing six positive and six negative swabs, so no variations in sizing or model options are mentioned.
How should the Cepheid Xpert CT/NG Control Panel be stored, and is sterility maintained?
The data does not explicitly detail storage conditions, but as a single-use control panel for molecular diagnostics, it is likely intended to be stored under standard laboratory conditions (e.g., room temperature, protected from light and contamination) until use. Sterility is implied for single-use medical devices, but specific storage instructions (e.g., refrigeration) are not provided.
What regulatory pathway was followed for the Cepheid Xpert CT/NG Control Panel, and is third-party certification required?
The device holds a 510(k) clearance (K190223) under FDA regulation 866.3920, classified as a Class II medical device. The advisory committee involved was Microbiology (MI), and no third-party certification is required, as indicated by the ‘third_party_flag: N’ in the data.
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: Microbiologics : 8188 Assayed CT/NG Control Panel, INSTRUCTIONS FOR USE - Microbiologics, Xpert® CT/NG - Cepheid, Cepheid Xpert CT / NG QC Sets and Panels - Medline
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190223 | Class II | Active |
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Manufacturer
- Manufacturer
- Microbiologics, Inc.
Sources (1)
- FDA 510(k) K190223 24 fields · synced Sep 18, 2026