Therascreen KRAS RGQ PCR Kit
FDA PMAClass III (US FDA PMA)
by QIAGEN GmbH
Identity
- Trade Name
- THERASCREEN KRAS RGQ PCR KIT FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P110027 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay classified as a Somatic Gene Mutation Detection System. It is designed for use on the Rotor-Gene Q MDx instrument to detect seven somatic mutations in the human KRAS oncogene from DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer (CRC) tissue. This assay aids in identifying KRAS mutation status to inform treatment decisions for patients with CRC.
The kit is supplied as a single-use diagnostic reagent intended for laboratory use. It requires compatibility with the Rotor-Gene Q MDx platform and is not intended for MRI or other imaging environments. Authorized under FDA_PMA (PMA Number: P110027), it is regulated as a Class III device. Storage and handling follow standard molecular diagnostics protocols to ensure assay integrity.
Frequently asked questions
What specific mutations in the KRAS oncogene does this kit detect, and how does it inform treatment decisions for colorectal cancer patients?
The Therascreen KRAS RGQ PCR Kit detects seven somatic mutations in the human KRAS oncogene. It is designed to identify whether a patient’s colorectal cancer tissue has a KRAS mutation, which helps determine eligibility for treatment with **Erbitux (cetuximab)** or **Vectoribix (panitumumab)**. These drugs are typically recommended only for patients with a *KRAS no mutation detected* result, as mutations may reduce their effectiveness.
Is this kit single-use, and if so, what does that mean for workflow efficiency in a clinical lab?
Yes, the Therascreen KRAS RGQ PCR Kit is supplied as a **single-use diagnostic reagent**, meaning each kit is intended for one assay run on the Rotor-Gene Q MDx instrument. This design ensures consistency and reduces cross-contamination risk but may require labs to plan usage carefully to avoid waste, especially when processing multiple samples.
What type of tissue sample is required for this assay, and are there any special handling or storage instructions?
The kit requires **DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue** as its input. Since FFPE samples are commonly used in pathology, this aligns with standard workflows for tissue-based diagnostics. Storage and handling must follow **standard molecular diagnostics protocols** to preserve assay integrity, though specific conditions (e.g., temperature) are not detailed in the data.
Which instrument is required to run this kit, and are there any compatibility concerns to consider?
The Therascreen KRAS RGQ PCR Kit is **exclusively compatible with the Rotor-Gene Q MDx instrument**—it is not designed for use with other platforms, including MRI or imaging systems. Labs must confirm their Rotor-Gene Q MDx model supports real-time PCR assays before purchasing, as compatibility is critical for accurate results.
How does the regulatory approval of this kit influence its use in clinical practice?
The kit holds **FDA PMA approval (PMA Number: P110027)** and is classified as a **Class III device**, indicating it undergoes rigorous review for safety and effectiveness. Its approval is specifically tied to use as a **companion diagnostic** for **Vectoribix (panitumumab)**, meaning it is primarily intended for guiding treatment decisions in colorectal cancer patients. Clinicians should verify local guidelines align with the FDA’s indicated use.
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 (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110027 | Class III | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA PMA P110027 24 fields · synced Sep 18, 2026