Cleared Traditional

K171771 - ADVIA Chemistry Enzymatic Hemoglobin A1...

K171771 is the FDA 510(k) clearance for ADVIA Chemistry Enzymatic Hemoglobin A1... by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code PDJ) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K171771 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Dec 2017
Decision
173d
Days
Class 2
Risk

K171771 is an FDA 510(k) clearance for the ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) 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 December 4, 2017 after a review of 173 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 K171771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2017
Decision Date December 04, 2017
Days to Decision 173 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
85d slower than avg
Panel avg: 88d · This submission: 173d
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 K171771.
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
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
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
K142595 · Ortho-Clinical Diagnostics · Jun 2015