Cleared Traditional

K811342 - REAGENT STRIPS FOR URINALYSIS (FDA 510(k) Clearance)

Class I Chemistry device.

K811342 · Miles Laboratories, Inc. · Chemistry device
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Sep 1981
Decision
112d
Days
Class 1
Risk

K811342 is an FDA 510(k) clearance for the REAGENT STRIPS FOR URINALYSIS. Classified as Refractometer For Clinical Use (product code JRE), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on September 1, 1981 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2800 - 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K811342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1981
Decision Date September 01, 1981
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRE Refractometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2800
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.