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U.S. Department of Health and Human Services

Product Classification

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Device osmolality of tears
Regulation Description Osmolality test system.
Definition To measure the osmolality 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.
Physical State Tear collection method and impendance measuring device.
Technical Method Electrical impedance measurement to provide an indirect assessment of osmolality.
Target Area Eye
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOND
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.1540
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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