Cleared Traditional

K113077 - BIOLAND G-423 GLOOD GLUCOSE MONITORING ...

K113077 is the FDA 510(k) clearance for BIOLAND G-423 GLOOD GLUCOSE MONITORING ... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K113077 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
291d
Days
Class 2
Risk

K113077 is an FDA 510(k) clearance for the BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on August 3, 2012 after a review of 291 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 Taidoc Technology Corporation devices

Submission Details

510(k) Number K113077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2011
Decision Date August 03, 2012
Days to Decision 291 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
203d slower than avg
Panel avg: 88d · This submission: 291d
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 182
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K113077.
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · Roche Diagnostics · Feb 2013
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · ACON Laboratories, Inc. · Dec 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · Roche Diagnostics · Oct 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K110074 · Health & Life Co., Ltd. · May 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
K111890 · Taidoc Technology Corporation · Feb 2012
GLUCOSE TEST SYSTEM
K113137 · Roche Diagnostics · Jan 2012