Cleared Traditional

K953873 - VARELISA HELICOBACTER PYLORI ANTIBODIES

K953873 is the FDA 510(k) clearance for VARELISA HELICOBACTER PYLORI ANTIBODIES by Elias U.S.A., Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K953873 · Elias U.S.A., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
379d
Days
Class 1
Risk

K953873 is an FDA 510(k) clearance for the VARELISA HELICOBACTER PYLORI ANTIBODIES. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on August 30, 1996 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K953873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1995
Decision Date August 30, 1996
Days to Decision 379 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 102d · This submission: 379d
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 44
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K953873.
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997
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
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · Quidel Corp. · Feb 1996