Cleared Traditional

CAMPYLOBACTER QUIK CHEK (K173217) - FDA 510(k) Clearance

Class I Microbiology device.

K173217 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
111d
Days
Class 1
Risk

K173217 is an FDA 510(k) clearance for the CAMPYLOBACTER QUIK 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 January 22, 2018 after a review of 111 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 Techlab, Inc. devices

Submission Details

510(k) Number K173217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2017
Decision Date January 22, 2018
Days to Decision 111 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
9d slower than avg
Panel avg: 102d · This submission: 111d
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 K173217.
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 CHEK
K173219 · Techlab, Inc. · Jan 2018
BBL CAMPYSLIDE(TM) TEST
K864027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986