Last Updated: March 2021
At Sight Diagnostics® we place the highest value on quality. As such, quality is an essential part of Sight’s goals and processes.
Sight’s Quality Management System policies define our arrangements for managing operations and activities across all disciplines and at all levels within the company in accordance with the framework established by the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485. Sight has also been certified by the Medical Device Single Audit Program (MDSAP).
Our Regulatory Affairs department manages registrations and listings with the FDA and all other regulatory authorities in territories in which Sight holds business.
To learn more about our regulatory and compliance approach, please refer to the information and links below:
Our policy is to provide products and services that exceed customer requirements for safety, reliability and effective performance. We achieve this Policy through Management and Associate commitment to customer satisfaction, continuous improvement, compliance with requirements and the maintenance of an effective Quality Management System.
Sight has been certified to ISO 13485 since 2015, which ensures our medical device meet all required quality requirements. A copy of our ISO certificate is available here.
Sight has also been certified by the Medical Device Single Audit Program (MDSAP). A copy of our MDSAP certificate is available here.
Manufacturers of all medical devices are required to register their establishments and list their devices with the FDA. To view registrations and listings on the FDA’s database, click here.
Sight OLO®’s Indications for Use
Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in K2EDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit microcapillary tubes.
When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EOS%/#, and BASO%/#.
Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.
Important safety information on Sight OLO