Cleared Traditional

K904655 - PYLORISET

K904655 is the FDA 510(k) clearance for PYLORISET by Orion Diagnostica, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K904655 · Orion Diagnostica, Inc. · Microbiology device
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Oct 1991
Decision
374d
Days
Class 1
Risk

K904655 is an FDA 510(k) clearance for the PYLORISET. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 21, 1991 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K904655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1990
Decision Date October 21, 1991
Days to Decision 374 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 102d · This submission: 374d
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 45
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K904655.
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
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991
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