Cleared Traditional

iHealth Align Gluco-Monitoring System (BG1) (K170231) - FDA 510(k) Clearance

Also marketed or referenced as:
iHealth Wireless Smart Gluco-Monitoring System (BG5) 

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

K170231 · Andon Health Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
233d
Days
Class 2
Risk

K170231 is an FDA 510(k) clearance for the iHealth Align Gluco-Monitoring System (BG1). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 15, 2017 after a review of 233 days - an extended review cycle.

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 Andon Health Co, Ltd. devices

Submission Details

510(k) Number K170231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date September 15, 2017
Days to Decision 233 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
145d slower than avg
Panel avg: 88d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 173
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K170231.
POGO Automatic Blood Glucose Monitoring System
K181316 · Intuity Medical, Inc. · Jun 2018
Dario LC Blood Glucose Monitoring System
K172723 · Labstyle Innovation, Ltd. · Mar 2018
On Call Express Mobile Blood Glucose Monitoring System
K180196 · ACON Laboratories, Inc. · Mar 2018
Smart Dongle Blood Glucose Monitoring System
K162382 · Taidoc Technology Corporation · Apr 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
K153561 · Andon Health Co, Ltd. · Feb 2017
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016