Cleared Traditional

K210976 - Curian Campy

K210976 is an FDA 510(k) clearance for Curian Campy, manufactured by Meridian Bioscience, Inc.. The device is a Class 1 Microbiology device with product code LQP cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K210976 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
266d
Days
Class 1
Risk

K210976 is an FDA 510(k) clearance for the Curian Campy. Classified as Campylobacter Spp. (product code LQP), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 23, 2021 after a review of 266 days - an extended review cycle.

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 Meridian Bioscience, Inc. devices

FDA 510(k) Submission Details - K210976

510(k) Number K210976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2021
Decision Date December 23, 2021
Days to Decision 266 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
164d slower than avg
Panel avg: 102d · This submission: 266d
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 K210976.
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
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · Meridian Bioscience, Inc. · May 2009