Cleared Special

K161834 - One Drop Blood Glucose Monitoring System

K161834 is an FDA 510(k) clearance for One Drop Blood Glucose Monitoring System, manufactured by Agamatrix, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 148-day FDA review.

K161834 · Agamatrix, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
148d
Days
Class 2
Risk

K161834 is an FDA 510(k) clearance for the One Drop Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Agamatrix, Inc. (Salem, US). The FDA issued a Cleared decision on November 30, 2016 after a review of 148 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. 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 - K161834

510(k) Number K161834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date November 30, 2016
Days to Decision 148 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
59d slower than avg
Panel avg: 89d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K161834.
Contour Next EZ Blood Glucose Monitoring System
K162336 · Ascensia Diabetes Care U.S., Inc. · Jan 2017
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
K161299 · Apex BioTechnology Corp. · Dec 2016
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · I-Sens, Inc. · Dec 2016
CONTOUR NEXT ONE Blood Glucose Monitoring System
K160682 · Ascensia Diabetes Care · Nov 2016
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
K160365 · Infopia Co, Ltd. · Sep 2016
K161834 · One Drop Blood Glucose Monitoring System
Download PDF FDA Summary Agamatrix, Inc.