Cleared Traditional

K915851 - QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

K915851 is an FDA 510(k) clearance for QUIDEL QUICKVUE H. PYLORI CONTROLS (POS..., manufactured by Quidel Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K915851 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
56d
Days
Class 1
Risk

K915851 is an FDA 510(k) clearance for the QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG). 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 February 21, 1992 after a review of 56 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

FDA 510(k) Submission Details - K915851

510(k) Number K915851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1991
Decision Date February 21, 1992
Days to Decision 56 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
46d faster than avg
Panel avg: 102d · This submission: 56d
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 56
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K915851.
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
PYLORISET
K904655 · Orion Diagnostica, Inc. · Oct 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991