Cleared Traditional

PYLORISET EIA-G (68926) (K971537) - FDA 510(k) Clearance

Class I Microbiology device.

K971537 · Orion Diagnostica, Div. Orion Corp. · Microbiology device
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Jun 1997
Decision
60d
Days
Class 1
Risk

K971537 is an FDA 510(k) clearance for the PYLORISET EIA-G (68926). Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Orion Diagnostica, Div. Orion Corp. (Espoo, FI). The FDA issued a Cleared decision on June 27, 1997 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orion Diagnostica, Div. Orion Corp. devices

Submission Details

510(k) Number K971537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date June 27, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
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 90
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