Cleared Traditional

K952517 - QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST

K952517 is an FDA 510(k) clearance for QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST, 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 251-day FDA review.

K952517 · Quidel Corp. · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
251d
Days
Class 1
Risk

K952517 is an FDA 510(k) clearance for the QUICKVUE ONE-STEP HELICOBACTOR PYLORI 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 February 6, 1996 after a review of 251 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 Quidel Corp. devices

FDA 510(k) Submission Details - K952517

510(k) Number K952517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date February 06, 1996
Days to Decision 251 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
149d slower than avg
Panel avg: 102d · This submission: 251d
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 K952517.
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc. · Jun 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