Cleared Traditional

K991747 - QUICKVUE ONE-STEP H. PYLORI II TEST

K991747 is the FDA 510(k) clearance for QUICKVUE ONE-STEP H. PYLORI II TEST by Quidel Corp.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K991747 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
75d
Days
Class 1
Risk

K991747 is an FDA 510(k) clearance for the QUICKVUE ONE-STEP H. PYLORI II TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 4, 1999 after a review of 75 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 Quidel Corp. devices

Submission Details

510(k) Number K991747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1999
Decision Date August 04, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 102d · This submission: 75d
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 32
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K991747.
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · bioMerieux, Inc. · Oct 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · Diagnostic Products Corp. · Jun 2000
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820 · Zeus Scientific, Inc. · Aug 1999
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · Meridian Diagnostics, Inc. · Dec 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · Abbott Laboratories · Nov 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790 · Inova Diagnostics, Inc. · Nov 1998