Cleared Special

K171650 - Alere Afinion HbA1c and ACR on Afinion 2 analyzer

K171650 is an FDA 510(k) clearance for Alere Afinion HbA1c and ACR on Afinion ..., manufactured by Abbott Rapid Diagnostics. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 169-day FDA review.

K171650 · Abbott Rapid Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
169d
Days
Class 2
Risk

K171650 is an FDA 510(k) clearance for the Alere Afinion HbA1c and ACR on Afinion 2 analyzer. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Abbott Rapid Diagnostics (San Diego, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 169 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171650

510(k) Number K171650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date November 21, 2017
Days to Decision 169 days
Submission Type Special
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
80d slower than avg
Panel avg: 89d · This submission: 169d
Pathway characteristics
Modification to existing cleared device.

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 247
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K171650.
Quo-Test A1c System
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
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · Alfa Wassermann Diagnostic Technologies, LLC · Feb 2018
Lucica Glycated Albumin-L
K170147 · Asahi Kasei Pharma Corporation · Oct 2017
cobas HbA1c Test, cobas b 101 system
K163633 · Roche Diagnostics Operations · Jul 2017
A1C EZ Glycohemoglobin Analysis System
K161533 · Biohermes Co., Ltd. · Jun 2017
K171650 · Alere Afinion HbA1c and ACR on Afinion 2 analyzer
Download PDF FDA Summary Abbott Rapid Diagnost…