Cleared Dual Track

Nova Allegro HbA1c Assay, Nova Allegro Analyzer

K221326 · Nova Biomedical Corporation · Chemistry
Nov 2024
Decision
931d
Days
Class 2
Risk

About This 510(k) Submission

K221326 is an FDA 510(k) clearance for the Nova Allegro HbA1c Assay, Nova Allegro Analyzer, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on November 22, 2024, 931 days after receiving the submission on May 6, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K221326 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2022
Decision Date November 22, 2024
Days to Decision 931 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

Similar Devices — LCP Assay, Glycosylated Hemoglobin

All 248
Q-Pad Test System
K231465 · Qurasense · Dec 2023
Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer
K214117 · Abbott Diagnostics Technologies AS · Sep 2023
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc. · Mar 2020
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · Ixensor Co, Ltd. · Oct 2019
OneDraw A1C Test System
K183230 · Drawbridge Health, Inc. · Aug 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K181915 · Ixensor Co, Ltd. · Apr 2019