Cleared Traditional

K192957 - VivaChek Blood Glucose and B-Ketone Mon...

K192957 is an FDA 510(k) clearance for VivaChek Blood Glucose and B-Ketone Mon..., manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 228-day FDA review.

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

FDA 510(k) Submission Details - K192957

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.

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 K192957.
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K060768 · Abbott Diabetes Care, Inc. · Apr 2006