Cleared Traditional

K173345 - TD-4140 Smart Dongle Blood Glucose plus...

K173345 is an FDA 510(k) clearance for TD-4140 Smart Dongle Blood Glucose plus..., manufactured by Taidoc Technology Corporation. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K173345 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
192d
Days
Class 1
Risk

K173345 is an FDA 510(k) clearance for the TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on May 4, 2018 after a review of 192 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - 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 Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K173345

510(k) Number K173345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2017
Decision Date May 04, 2018
Days to Decision 192 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
104d slower than avg
Panel avg: 88d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

JIN Device Classification - Class 1, General Controls

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 11
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K173345.
KetoSens BT Blood B-Ketone Monitoring System
K201551 · I-Sens, Inc. · Sep 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · Vivachek Biotech (Hangzhou) Co., Ltd. · Jun 2020
KET-1 Blood Ketone Monitoring System
K182593 · Apex BioTechnology Corp. · Dec 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463 · I-Sens, Inc. · Apr 2018
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587 · ACON Laboratories, Inc. · Jul 2017
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · Abbott Diabetes Care, Inc. · Apr 2006