Cleared Traditional

ACE Hemoglobin A1c (HbA1c) Reagent (K170623) - FDA 510(k) Clearance

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

K170623 · Alfa Wassermann Diagnostic Technologies, LLC · Chemistry device
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Feb 2018
Decision
363d
Days
Class 2
Risk

K170623 is an FDA 510(k) clearance for the ACE Hemoglobin A1c (HbA1c) Reagent. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on February 27, 2018 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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. Elevated predicate reliance profile. 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 Alfa Wassermann Diagnostic Technologies, LLC devices

Submission Details

510(k) Number K170623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date February 27, 2018
Days to Decision 363 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
275d slower than avg
Panel avg: 88d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 98
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K170623.
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
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K180509 · Ekf Diagnostic GmbH · Feb 2019
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
K173127 · Skyla Corporation H.S.P.B · Sep 2018
URight Hemoglobin A1c system, FORA A1c System
K142664 · Taidoc Technology Corporation · Jan 2016
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · Beckman Coulter, Inc. · Jul 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · Siemens Healthcare Diagnostics, Inc. · Jan 2014