Cleared Traditional

K904655 - PYLORISET

K904655 is an FDA 510(k) clearance for PYLORISET, manufactured by Orion Diagnostica, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K904655

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 102d · This submission: 374d
Pathway characteristics
Predicate-based equivalence.

LYR Device Classification - Class 1, General Controls

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 74
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K904655.
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689 · United Biotech, Inc. · Aug 1993
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