Cleared Traditional

K953873 - VARELISA HELICOBACTER PYLORI ANTIBODIES

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

K953873 · Elias U.S.A., Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K953873

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.

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 74
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K953873.
H.PYLORI CONTROLS
K964675 · Pyramid Biological Corp. · Jan 1997
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · Meretek Diagnostics, Inc. · Sep 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996
ACCUMETER H. PYLORI TEST
K960478 · Chemtrak, Inc. · Jun 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc. · Jun 1996