Cleared Traditional

QUIX RAPID E. COLI O157 STRIP TEST (K972156) - FDA 510(k) Clearance

Class I Microbiology device.

K972156 · Guardian Scientific, Corp. · Microbiology device
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Oct 1997
Decision
129d
Days
Class 1
Risk

K972156 is an FDA 510(k) clearance for the QUIX RAPID E. COLI O157 STRIP TEST. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Guardian Scientific, Corp. (Columbia, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Guardian Scientific, Corp. devices

Submission Details

510(k) Number K972156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date October 16, 1997
Days to Decision 129 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 102d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GMZ Antigens, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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.