Cleared Traditional

K905468 - PYLORI-G FIAX TEST KIT

K905468 is the FDA 510(k) clearance for PYLORI-G FIAX TEST KIT by Whittaker Bioproducts, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K905468 · Whittaker Bioproducts, Inc. · Microbiology device
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May 1991
Decision
152d
Days
Class 1
Risk

K905468 is an FDA 510(k) clearance for the PYLORI-G FIAX TEST KIT. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 152 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 Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K905468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date May 07, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 102d · This submission: 152d
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 45
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K905468.
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · E-Z-Em, Inc. · Jun 1991
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