Cleared Traditional

K912442 - QUIDEL HELICOBACTER PYLORI MICROWELL EI...

K912442 is the FDA 510(k) clearance for QUIDEL HELICOBACTER PYLORI MICROWELL EI... by Quidel Corp.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K912442 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
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Sep 1991
Decision
105d
Days
Class 1
Risk

K912442 is an FDA 510(k) clearance for the QUIDEL HELICOBACTER PYLORI MICROWELL EIA 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 September 16, 1991 after a review of 105 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K912442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date September 16, 1991
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
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 K912442.
PREMIER(TM) H. PYLORY
K945558 · Meridian Diagnostics, Inc. · Mar 1995
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049 · Quidel Corp. · May 1991
QUIDEL HELICOBACTER PYLORI TEST
K903099 · Quidel Corp. · Apr 1991
SELECTIVE RAPID UREA
K883641 · Remel Co. · May 1989