Cleared Traditional

K862806 - URINE DIAGNOSTIC REAGENT STRIPS

K862806 is an FDA 510(k) clearance for URINE DIAGNOSTIC REAGENT STRIPS, manufactured by Amatech International, Inc.. The device is a Class 1 Chemistry device with product code JJB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K862806 · Amatech International, Inc. · Chemistry device
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Dec 1986
Decision
134d
Days
Class 1
Risk

K862806 is an FDA 510(k) clearance for the URINE DIAGNOSTIC REAGENT STRIPS. Classified as Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) (product code JJB), Class I - General Controls.

Submitted by Amatech International, Inc. (Houston, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1115 - 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 Amatech International, Inc. devices

FDA 510(k) Submission Details - K862806

510(k) Number K862806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1986
Decision Date December 04, 1986
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

JJB Device Classification - Class 1, General Controls

Product Code JJB Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1115
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.