Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: MiRXES GASTROClear [MiRXES Pte. Ltd.]
Description: The GASTROClear, an in-vitro diagnostic medical device (IVD), is intended for use as an adjunctive test for the detection of gastric neoplasia associated miRNA biomarkers in human serum. GASTROClear is NOT intended as a replacement for gastroscopy; it should be used in conjunction with gastroscopy and other test methods in accordance with recognized clinical guidelines. It is thus an adjunctive tool to aid in the detection of gastric cancer. As such, only patients who met certain criteria are tested using GASTROClear. The result obtained from the test may indicate the presence of gastric cancer and the patient then goes for gastroscopy and biopsy as required. The output of GASTROClear test is a risk score where a high score may indicate the presence of gastric cancer and should be followed up by gastroscopy. This test is intended for adults of either sex, 40 years or older at average risk of having gastric cancer.
Medical Specialty Area: Gastroenterology & Urology
Medical Device Class: Class C IVD
Device Registration No: DE0503083
Registration Date: 09/05/2019
Change Notification Approval Date: Not Applicable
 
Product Owner
1. MiRXES Pte. Ltd.  [MiRXES Pte. Ltd.] 2 TUKANG INNOVATION GROVE, JTC MEDTECH HUB, #08-01, SINGAPORE 618305
Registrant
1. MIRXES Pte Ltd  2 TUKANG INNOVATION GROVE, JTC MEDTECH HUB, #08-01, SINGAPORE 618305
Models
No. Model Name Identifier
1GASTROClear Pack 1 of 3 - Assay210101
2GASTROClear Pack 2 of 3 - Extraction210201
3GASTROClear Pack 3 of 3 - Reagent210301
4Gastrosmart210401
 
Note: All device listings on the Singapore Medical Device Register (SMDR) are active.