Cleared Traditional

K971537 - PYLORISET EIA-G (68926)

K971537 is an FDA 510(k) clearance for PYLORISET EIA-G (68926), manufactured by Orion Diagnostica, Div. Orion Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 60-day FDA review.

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

FDA 510(k) Submission Details - K971537

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
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 62
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K971537.
PYLORI DETECT IGG
K973508 · Micro Detect, Inc. · Mar 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · Consolidated Technologies, Inc. · Jul 1997
ACCUMETER H. PYLORI TEST
K965099 · Chemtrak, Inc. · Feb 1997
H.PYLORI CONTROLS
K964675 · Pyramid Biological Corp. · Jan 1997
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997