Cleared Traditional

K991820 - HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI (FDA 510(k) Clearance)

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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.