Cleared Traditional

K102316 - GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORI...

K102316 is the FDA 510(k) clearance for GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORI... by Broadmaster Biotech Corporation. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K102316 · Broadmaster Biotech Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
417d
Days
Class 2
Risk

K102316 is an FDA 510(k) clearance for the GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Broadmaster Biotech Corporation (Zhonghe City, TW). The FDA issued a Cleared decision on October 7, 2011 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Broadmaster Biotech Corporation devices

Submission Details

510(k) Number K102316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2010
Decision Date October 07, 2011
Days to Decision 417 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
329d slower than avg
Panel avg: 88d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K102316.
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
K120448 · Apex BioTechnology Corp. · Apr 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
K113547 · Apex BioTechnology Corp. · Mar 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · Apex BioTechnology Corp. · Jan 2012
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · ACON Laboratories, Inc. · Oct 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
K101204 · Apex BioTechnology Corp. · Aug 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842 · Beckman Coulter, Inc. · Apr 2011