Cleared Traditional

K912255 - HYCOR PYLORAGEN HELICOBACTER PYLORI TEST

K912255 is the FDA 510(k) clearance for HYCOR PYLORAGEN HELICOBACTER PYLORI TEST by Hycor Biomedical, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K912255 · Hycor Biomedical, Inc. · Microbiology device
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Oct 1991
Decision
142d
Days
Class 1
Risk

K912255 is an FDA 510(k) clearance for the HYCOR PYLORAGEN HELICOBACTER PYLORI TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 142 days - within the typical 510(k) review window.

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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K912255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1991
Decision Date October 11, 1991
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
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 K912255.
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · Hycor Biomedical, Inc. · Sep 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · E-Z-Em, Inc. · Jun 1991
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049 · Quidel Corp. · May 1991