Cleared Traditional

K160571 - cobas c513 Analyzer

K160571 is the FDA 510(k) clearance for cobas c513 Analyzer by Roche Diagnostics Operations (Rdo). It is a Class 2 Chemistry device (product code PDJ) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K160571 · Roche Diagnostics Operations (Rdo) · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2016
Decision
294d
Days
Class 2
Risk

K160571 is an FDA 510(k) clearance for the cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on December 19, 2016 after a review of 294 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Operations (Rdo) devices

Submission Details

510(k) Number K160571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 88d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - PDJ Hemoglobin A1c Test System

All 20
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K160571.
Afinion HbA1c Dx
K180296 · Alere Technologies AS · May 2018
CAPILLARYS Hb A1c
K171861 · Sebia · Feb 2018
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · Siemens Healthcare Diagnostics, Inc. · Dec 2017
D-10 Hemoglobin A1c Program
K161687 · Bio-Rad Laboratories, Inc. · Oct 2016
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · Bio-Rad Laboratories, Inc. · Dec 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · Abbott Laboratories · May 2015