Cleared Traditional

K982315 - PROSPECT CAMPYLOBACTER MICROPLATE ASSAY

K982315 is an FDA 510(k) clearance for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY, manufactured by Alexon - Trend, Inc.. The device is a Class 1 Microbiology device with product code LQP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K982315 · Alexon - Trend, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K982315

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

LQP Device Classification - Class 1, General Controls

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 10
Devices cleared under the same product code (LQP) and FDA review panel - the closest regulatory comparables to K982315.
CAMPYLOBACTER CHEK
K173219 · Techlab, Inc. · Jan 2018
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · Meridian Bioscience, Inc. · May 2009
PREMIER CAMPY, MODEL 618096
K083464 · Meridian Bioscience, Inc. · Jan 2009
MERITEC(TM)-CAMPY (JCL)
K880389 · Meridian Diagnostics, Inc. · Apr 1988
BBL CAMPYSLIDE(TM) TEST
K864027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986