Cleared Traditional

K972156 - QUIX RAPID E. COLI O157 STRIP TEST

K972156 is an FDA 510(k) clearance for QUIX RAPID E. COLI O157 STRIP TEST, manufactured by Guardian Scientific, Corp.. The device is a Class 1 Microbiology device with product code GMZ cleared through the Traditional 510(k) pathway after a 129-day FDA review.

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

FDA 510(k) Submission Details - K972156

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 102d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

GMZ Device Classification - Class 1, General Controls

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.