Cleared Traditional

cobas HbA1c Test, cobas b 101 system

K163633 · Roche Diagnostics Operations · Chemistry
Jul 2017
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K163633 is an FDA 510(k) clearance for the cobas HbA1c Test, cobas b 101 system, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Roche Diagnostics Operations (Indianapolos, US). The FDA issued a Cleared decision on July 28, 2017, 218 days after receiving the submission on December 22, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K163633 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2016
Decision Date July 28, 2017
Days to Decision 218 days
Submission Type Traditional
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
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · Nova Biomedical Corporation · Nov 2024
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