Cleared Traditional

K163271 - i-Stat Alinity System with i-Stat Gluco...

K163271 is an FDA 510(k) clearance for i-Stat Alinity System with i-Stat Gluco..., manufactured by Abbott Point of Care, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K163271 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
140d
Days
Class 2
Risk

K163271 is an FDA 510(k) clearance for the i-Stat Alinity System with i-Stat Glucose test. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on April 10, 2017 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Abbott Point of Care, Inc. devices

FDA 510(k) Submission Details - K163271

510(k) Number K163271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date April 10, 2017
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 223
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K163271.
PTS Professional Chemistry Kit
K182781 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · Dec 2018
Stat Profile Prime Plus Analyzer System
K180340 · Nova Biomedical Corporation · Sep 2018
VITROS Chemistry Products GLU Slides
K163433 · Ortho-Clinical Diagnostics · Sep 2017
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · Instrumentation Laboratory CO · Dec 2016
GEM Premier 3000
K161818 · Instrumentation Laboratory CO · Sep 2016
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
K142689 · Apex BioTechnology Corp. · Aug 2015