Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)
Primary DI
00810111410731
Brand
Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
VS01S
Device description
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older. The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider. The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic. The testing is performed, as determined to be appropriate, based on the results ofLetsGetChecked Suitability Questionnaire. This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider. Testing is limited to the manufacturer, PrivaPath laboratories (d.b.a. LetsGetChecked, Inc.).
A collection of devices intended to be used by a layperson in the home to collect a clinical specimen for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.