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)
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.

View all Abbott Rapid Diagnostics devices

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
81d slower than avg
Panel avg: 88d · 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 202
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