Cleared Traditional

K982362 - ABBOTT TESTPACK PLUS H. PYLORI

K982362 is an FDA 510(k) clearance for ABBOTT TESTPACK PLUS H. PYLORI, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K982362 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
135d
Days
Class 1
Risk

K982362 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS H. PYLORI. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 135 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K982362

510(k) Number K982362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date November 18, 1998
Days to Decision 135 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 102d · This submission: 135d
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 K982362.
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820 · Zeus Scientific, Inc. · Aug 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp. · Aug 1999
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · Meridian Diagnostics, Inc. · Dec 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
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998