Cleared Traditional

K905409 - EIA FOR DETECTION OF ANTIBODIES H. PYLORI

K905409 is the FDA 510(k) clearance for EIA FOR DETECTION OF ANTIBODIES H. PYLORI by E-Z-Em, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K905409 · E-Z-Em, Inc. · Microbiology device
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Jun 1991
Decision
189d
Days
Class 1
Risk

K905409 is an FDA 510(k) clearance for the EIA FOR DETECTION OF ANTIBODIES H. PYLORI. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by E-Z-Em, Inc. (North Caldwell, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 189 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K905409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date June 10, 1991
Days to Decision 189 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
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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 - LYR Helicobacter Pylori

All 44
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K905409.
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049 · Quidel Corp. · May 1991
QUIDEL HELICOBACTER PYLORI TEST
K903099 · Quidel Corp. · Apr 1991
SELECTIVE RAPID UREA
K883641 · Remel Co. · May 1989