Cleared Traditional

VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) - FDA 510(k) Clearance

Class I Chemistry device.

K192957 · Vivachek Biotech (Hangzhou) Co., Ltd. · Chemistry device
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Jun 2020
Decision
228d
Days
Class 1
Risk

K192957 is an FDA 510(k) clearance for the VivaChek Blood Glucose and B-Ketone Monitoring System. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 5, 2020 after a review of 228 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 Vivachek Biotech (Hangzhou) Co., Ltd. devices

Submission Details

510(k) Number K192957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2019
Decision Date June 05, 2020
Days to Decision 228 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
140d slower than avg
Panel avg: 88d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 9
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K192957.
KetoSens BT Blood B-Ketone Monitoring System
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KET-1 Blood Ketone Monitoring System
K182593 · Apex BioTechnology Corp. · Dec 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · Taidoc Technology Corporation · May 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
ABBOTT BREATH ACETONE ANALYZER
K875029 · Abbott Laboratories · May 1988