Cleared Traditional

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

K121610 · Roche Diagnostics Operations · Chemistry

Aug 2013

Decision

433d

Days

Class 2

Risk

About This 510(k) Submission

K121610 is an FDA 510(k) clearance for the COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Roche Diagnostics Operations (Indianpolis, US). The FDA issued a Cleared decision on August 8, 2013, 433 days after receiving the submission on June 1, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K121610 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2012
Decision Date	August 08, 2013
Days to Decision	433 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.