Cleared Traditional

K010520 - GEM PREMIER 3000- ADDITION OF GLUCOSE A...

K010520 is the FDA 510(k) clearance for GEM PREMIER 3000- ADDITION OF GLUCOSE A... by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K010520 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
74d
Days
Class 2
Risk

K010520 is an FDA 510(k) clearance for the GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 7, 2001 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K010520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2001
Decision Date May 07, 2001
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 132
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K010520.
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · Becton, Dickinson & CO · Oct 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158 · Instrumentation Laboratory CO · Sep 2002
DIABETES ASSISTANT SOFTWARE
K014139 · Roche Diagnostics Corp. · Mar 2002
RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd. · Mar 2001
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000