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The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.

The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the cliagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The device consists of the following components and accessories: One Tearl.ab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Sinqle Use TearLab Osmolarity Test Cards, and TearLab Control Solutions. The TearLab Osmolarity Test Card, in conjunction with the TearLab Osmolarity System, provides a quick and simple method for determining tear osmolarity using nanoliter (nL) volumes of tear fluid collected directly from the eyelid margin. To perform a test, a new Test Card containing a microfluidic capillary channel is attached onto the Pen. The tip of the Test Card is touched to the inferior tear meniscus located above the lower eyelid and collects 40-50 nanoliters of tear fluid by passive capillary action. After a successful collection, the Pen in conjunction with the electrodes embedded on the Test Card, measures and stores the tear fluid impedance. The Pen is then docked to the Reader. The Reader downloads impedance data from the Pen in order to calculate and display the final osmolarity as a numerical value displayed in units of mOsms/L. The TearLab Osmolarity System simplifies the tear collection process by reducing the required specimen volume to nanoliters, eliminating the need to transfer tear fluid and reducing the risk of evaporation.