Cleared Traditional

Dimension Hemoglobin A1c Assay (K173909) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173909 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
203d
Days
Class 2
Risk

K173909 is an FDA 510(k) clearance for the Dimension Hemoglobin A1c Assay. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 203 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K173909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date July 13, 2018
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
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 16
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K173909.
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · Roche Diagnostics Operations (Rdo) · Mar 2020
HbA1c Advanced
K182651 · Beckman Coulter Ireland, Inc. · Jan 2019
Afinion HbA1c Dx on Afinion 2
K182988 · Alere Technologies AS · Nov 2018
SEKURE HbA1c Assay
K173206 · Sekisui Diagnostics P.E.I., Inc. · Jul 2018
Afinion HbA1c Dx
K180296 · Alere Technologies AS · May 2018
CAPILLARYS Hb A1c
K171861 · Sebia · Feb 2018