Cleared Traditional

K925190 - PYLORISCREEN

K925190 is an FDA 510(k) clearance for PYLORISCREEN, manufactured by New Horizons Diagnostics Co.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K925190 · New Horizons Diagnostics Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
160d
Days
Class 1
Risk

K925190 is an FDA 510(k) clearance for the PYLORISCREEN. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by New Horizons Diagnostics Co. (Columbia, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 160 days - an extended review 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: 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 New Horizons Diagnostics Co. devices

FDA 510(k) Submission Details - K925190

510(k) Number K925190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1992
Decision Date March 23, 1993
Days to Decision 160 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
58d slower than avg
Panel avg: 102d · This submission: 160d
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 75
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K925190.
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994
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
PYLORISET
K904655 · Orion Diagnostica, Inc. · Oct 1991