Cleared Traditional

TEARLAB OSMOLARITY SYSTEM (K083184) - FDA 510(k) Clearance

Class I Chemistry device.

K083184 · Ocusense, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
198d
Days
Class 1
Risk

K083184 is an FDA 510(k) clearance for the TEARLAB OSMOLARITY SYSTEM. Classified as Osmolality Of Tears (product code OND), Class I - General Controls.

Submitted by Ocusense, Inc. (Philedelphia, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 198 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1540 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ocusense, Inc. devices

Submission Details

510(k) Number K083184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date May 14, 2009
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 88d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OND Osmolality Of Tears
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1540
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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.