Cleared Traditional

K170623 - ACE Hemoglobin A1c (HbA1c) Reagent

K170623 is an FDA 510(k) clearance for ACE Hemoglobin A1c (HbA1c) Reagent, manufactured by Alfa Wassermann Diagnostic Technologies, LLC. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 363-day FDA review.

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

FDA 510(k) Submission Details - K170623

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.

LCP Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K170623.
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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
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · Sebia · Feb 2017
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
K160762 · Diazyme Laboratories · Nov 2016
URight Hemoglobin A1c system, FORA A1c System
K142664 · Taidoc Technology Corporation · Jan 2016