Cleared Traditional

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315) - FDA 510(k) Clearance

Class I Microbiology device.

K982315 · Alexon - Trend, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
140d
Days
Class 1
Risk

K982315 is an FDA 510(k) clearance for the PROSPECT CAMPYLOBACTER MICROPLATE ASSAY. Classified as Campylobacter Spp. (product code LQP), Class I - General Controls.

Submitted by Alexon - Trend, Inc. (Ramsey, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 140 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 Alexon - Trend, Inc. devices

Submission Details

510(k) Number K982315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date November 18, 1998
Days to Decision 140 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
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQP Campylobacter Spp.
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 - LQP Campylobacter Spp.

All 11
Devices cleared under the same product code (LQP) and FDA review panel - the closest regulatory comparables to K982315.
Curian Campy
K210976 · Meridian Bioscience, Inc. · Dec 2021
Sofia 2 Campylobacter FIA
K211342 · Quidel Corporation · Nov 2021
Campylobacter Chek
K191442 · Techlab, Inc. · Jun 2019
Campylobacter Quik Chek
K191456 · Techlab, Inc. · Jun 2019
CAMPYLOBACTER QUIK CHEK
K173217 · Techlab, Inc. · Jan 2018
CAMPYLOBACTER CHEK
K173219 · Techlab, Inc. · Jan 2018