Cleared Dual Track

Kenota 1 Total IgE (K231151) - FDA 510(k) Clearance

Also marketed or referenced as:
Kenota 1 (instrument)

Class II Immunology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K231151 · Kenota, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
403d
Days
Class 2
Risk

K231151 is an FDA 510(k) clearance for the Kenota 1 Total IgE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Kenota, Inc. (Kitchener, CA). The FDA issued a Cleared decision on May 31, 2024 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Kenota, Inc. devices

Submission Details

510(k) Number K231151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2023
Decision Date May 31, 2024
Days to Decision 403 days
Submission Type Dual Track
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 104d · This submission: 403d
Pathway characteristics

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K231151.
Quantia IgE
K214068 · Biokit, S.A. · Feb 2023
Total Immunoglobulin E (IgE)
K220178 · Beckman Coulter, Inc. · Mar 2022
ADVIA Centaur Total IgE (tIgE)
K193493 · Siemens Healthcare Diagnostics, Inc. · Jan 2020
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc. · Feb 2007
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · Beckman Coulter, Inc. · Feb 2003
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001