Praxis Extended RAS Panel
FDA premarket approval P160038 · decided 2017-06-29
Approval details
- PMA number
- P160038
- Trade name
- Praxis Extended RAS Panel
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Illumina, Inc.
- Date received
- 2016-09-02
- Decision date
- 2017-06-29
- Days to decision
- 300 days
- Decision code
- APWD
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- San Diego, CA
- Statement
- Approval for the Praxis Extended RAS Panel is a qualitative in vitro diagnostic test using targeted high throughput parallel sequencing for the detection of 56 specific mutations in RAS genes [KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4)] in DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The Praxis Extended RAS Panel is indicated to aid in the identification of patients with colorectal cancer for treatment with Vectibix® (panitumumab
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MISEQDX UNIVERSAL KIT 1.0 (DEN130042) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (K124006) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (K132750) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA BEADXPRESS SYSTEM (K093128) | Illumina, Inc. | 2010-04-28 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |