Cleared Traditional

K982790 - QUANTA LITE H. PYLORI IGG ELISA

K982790 is the FDA 510(k) clearance for QUANTA LITE H. PYLORI IGG ELISA by Inova Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K982790 · Inova Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
86d
Days
Class 1
Risk

K982790 is an FDA 510(k) clearance for the QUANTA LITE H. PYLORI IGG ELISA. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 86 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K982790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date November 04, 1998
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
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 K982790.
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp. · Aug 1999
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · Meridian Diagnostics, Inc. · Dec 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · Abbott Laboratories · Nov 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · Princeton BioMeditech Corp. · Sep 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998