Cleared Traditional

Tina-quant Hemoglobin A1cDx Gen.3

K193053 · Roche Diagnostics Operations (Rdo) · Chemistry

Mar 2020

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K193053 is an FDA 510(k) clearance for the Tina-quant Hemoglobin A1cDx Gen.3, 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 March 26, 2020, 146 days after receiving the submission on November 1, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K193053 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2019
Decision Date	March 26, 2020
Days to Decision	146 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.