Cleared Traditional

K991820 - HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI

K991820 is an FDA 510(k) clearance for HELICOBACTER PYLORI IGG ELISA TEST SYST..., manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K991820 · Zeus Scientific, Inc. · Microbiology device
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Aug 1999
Decision
77d
Days
Class 1
Risk

K991820 is an FDA 510(k) clearance for the HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASS.... Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K991820

510(k) Number K991820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date August 12, 1999
Days to Decision 77 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
25d faster than avg
Panel avg: 102d · This submission: 77d
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 78
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K991820.
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · Diagnostic Products Corp. · Jun 2000
UNI-GOLD H. PYLORI
K991697 · Trinity Biotech, Plc · Dec 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · Columbia Bioscience, Inc. · Sep 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp. · Aug 1999
PRONTO DRY
K991248 · Medical Instruments Corporation Mic AG · Jun 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
K984544 · Enteric Products, Inc. · Feb 1999