Cleared Traditional

K980821 - HELICOBACTER PYLORI IGG ELISA TEST SYSTEM

K980821 is an FDA 510(k) clearance for HELICOBACTER PYLORI IGG ELISA TEST SYSTEM, 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 149-day FDA review.

K980821 · Zeus Scientific, Inc. · Microbiology device
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Jul 1998
Decision
149d
Days
Class 1
Risk

K980821 is an FDA 510(k) clearance for the HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 30, 1998 after a review of 149 days - within the typical 510(k) review window.

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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K980821

510(k) Number K980821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date July 30, 1998
Days to Decision 149 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
47d slower than avg
Panel avg: 102d · This submission: 149d
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 50
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K980821.
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · Abbott Laboratories · Nov 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790 · Inova Diagnostics, Inc. · Nov 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · Princeton BioMeditech Corp. · Sep 1998
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · Shield Diagnostics, Ltd. · Mar 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998