Cleared Traditional

K884026 - ESCHERICHIA COLI 0157 LATEX AGGLUTINATI...

K884026 is the FDA 510(k) clearance for ESCHERICHIA COLI 0157 LATEX AGGLUTINATI... by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (product code GNA) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K884026 · Oxoid U.S.A., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
133d
Days
Class 1
Risk

K884026 is an FDA 510(k) clearance for the ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 133 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K884026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1988
Decision Date February 03, 1989
Days to Decision 133 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 102d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNA Antisera, 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.

Regulatory Peers - GNA Antisera, All Types, Escherichia Coli

All 7
Devices cleared under the same product code (GNA) and FDA review panel - the closest regulatory comparables to K884026.
PREMIER EHEC
K953362 · Meridian Diagnostics, Inc. · Nov 1995
PREMIER EHEC
K950167 · Meridian Diagnostics, Inc. · Apr 1995
RIM E.COLI 0157:H7 LATEX TEST
K933457 · Remel Co. · Apr 1994
PHADEBACT ETEC-LT TEST
K874288 · Pharmacia, Inc. · Sep 1988
DIAGNOSTIC REAGENT VET-RPLA
K855234 · Oxoid U.S.A., Inc. · Nov 1986