Cleared Traditional

GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM (K991156) - FDA 510(k) Clearance

Class I Chemistry device.

K991156 · Great Smokies Diagnostic Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
51d
Days
Class 1
Risk

K991156 is an FDA 510(k) clearance for the GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM. Classified as Colorimetric, Xylose (product code JOC), Class I - General Controls.

Submitted by Great Smokies Diagnostic Laboratory (Asheville, US). The FDA issued a Cleared decision on May 28, 1999 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Great Smokies Diagnostic Laboratory devices

Submission Details

510(k) Number K991156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date May 28, 1999
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JOC Colorimetric, Xylose
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1820
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.