Cleared Special

Campylobacter Chek (K191442) - FDA 510(k) Clearance

Class I Microbiology device.

K191442 · Techlab, Inc. · Microbiology device
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Jun 2019
Decision
21d
Days
Class 1
Risk

K191442 is an FDA 510(k) clearance for the Campylobacter Chek. Classified as Campylobacter Spp. (product code LQP), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on June 20, 2019 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Techlab, Inc. devices

Submission Details

510(k) Number K191442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date June 20, 2019
Days to Decision 21 days
Submission Type Special
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
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K191442.
Curian Campy
K210976 · Meridian Bioscience, Inc. · Dec 2021
Sofia 2 Campylobacter FIA
K211342 · Quidel Corporation · Nov 2021
Campylobacter Quik Chek
K191456 · Techlab, Inc. · Jun 2019
CAMPYLOBACTER QUIK CHEK
K173217 · Techlab, Inc. · Jan 2018
CAMPYLOBACTER CHEK
K173219 · Techlab, Inc. · Jan 2018
BBL CAMPYSLIDE(TM) TEST
K864027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986