Cleared Traditional

K944903 - HP-FAST

K944903 is an FDA 510(k) clearance for HP-FAST, manufactured by Gi Supply. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K944903 · Gi Supply · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
198d
Days
Class 1
Risk

K944903 is an FDA 510(k) clearance for the HP-FAST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on April 20, 1995 after a review of 198 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 Gi Supply devices

FDA 510(k) Submission Details - K944903

510(k) Number K944903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1994
Decision Date April 20, 1995
Days to Decision 198 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
96d slower than avg
Panel avg: 102d · This submission: 198d
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 51
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K944903.
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · Quidel Corp. · Feb 1996
HM-CAP CONTROL PANEL
K954926 · E-Z-Em, Inc. · Jan 1996
SERIM PYLORITEK TEST KIT
K953632 · Serim Research Corp. · Dec 1995
PREMIER(TM) H. PYLORY
K945558 · Meridian Diagnostics, Inc. · Mar 1995
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994