510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

A. 510(k) Number: k093974 B. Purpose for Submission: New Device C. Measurand: Factor II (FII) (Prothrombin) Factor V (FV) Leiden 5, 10 methylenetetrahydrofolate reductase (MTHFR) D. Type of Test: Qualitative genotyping test for single nucleotide polymorphism detection E. Applicant: Osmetech Molecular Diagnostics F. Proprietary and Established Names: eSensor® Thrombophilia Risk Test eSensor® FII-FV Genotyping Test eSensor® FII Genotyping Test eSensor® FV Genotyping Test eSensor® MTHFR Genotyping Test G. Regulatory Information: 1. Regulation section: 21 CFR §864.7280 Factor V Leiden DNA Mutation Detection Systems 21 CFR §862.2570 Instrumentation for Clinical Multiplex Test Systems 2. Classification: Class II 3. Product code: NPQ: Test, Factor V Leiden Mutations, Genomic DNA PCR NPR: Test, Factor II G20210A Mutations, Genomic DNA PCR OMM: Test 5,10-Methylenetetrahydrofolate Reductase Mutations, Genomic DNA PCR NSU: Instrumentation for Clinical Multiplex Test Systems 4. Panel: Hematology (81); Chemistry (75) H. Intended Use: 1. Intended use(s): a. The eSensor® Thrombophilia Risk Test is an in vitro diagnostic for the detection and genotyping of Factor II (Prothrombin) G20210A, Factor V (Factor V Leiden) G1691A and MTHFR (human 5, 10 methylenetetrahydrofolate reductase gene) C677T and A1298C mutations in patients with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System. b. The eSensor® FII-FV Genotyping Test is an in vitro diagnostic for detection