Cleared Traditional

TRUENESS™ AIR Blood Glucose Monitoring System (K231476) - FDA 510(k) Clearance

Also marketed or referenced as:
TRUENESS™ Blood Glucose Monitoring System

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

K231476 · Sinocare, Inc. · Chemistry device
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Dec 2023
Decision
193d
Days
Class 2
Risk

K231476 is an FDA 510(k) clearance for the TRUENESS™ AIR Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Sinocare, Inc. (Changsha, CN). The FDA issued a Cleared decision on December 1, 2023 after a review of 193 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 Sinocare, Inc. devices

Submission Details

510(k) Number K231476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2023
Decision Date December 01, 2023
Days to Decision 193 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
105d slower than avg
Panel avg: 88d · This submission: 193d
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 165
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