Cleared Traditional

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

K160571 · Roche Diagnostics Operations (Rdo) · Chemistry

Dec 2016

Decision

294d

Days

Class 2

Risk

About This 510(k) Submission

K160571 is an FDA 510(k) clearance for the cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on December 19, 2016, 294 days after receiving the submission on February 29, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K160571 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 29, 2016
Decision Date	December 19, 2016
Days to Decision	294 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PDJ — Hemoglobin A1c Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1373
Definition	Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.