Cleared Traditional

E. COLI 0157 ELISA STOOL ASSAY (K942705) - FDA 510(k) Clearance

Class I Microbiology device.

K942705 · Lmd Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
476d
Days
Class 1
Risk

K942705 is an FDA 510(k) clearance for the E. COLI 0157 ELISA STOOL ASSAY. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Lmd Laboratories (Carlsbad, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K942705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date September 27, 1995
Days to Decision 476 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 102d · This submission: 476d
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.