Cleared Traditional

K912440 - ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K912440 is an FDA 510(k) clearance for ULTRA BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Home Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K912440 · Home Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
44d
Days
Class 2
Risk

K912440 is an FDA 510(k) clearance for the ULTRA BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Eatontown, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 44 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.

FDA 510(k) Submission Details - K912440

510(k) Number K912440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date July 17, 1991
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 89d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

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 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K912440.
YSI MODEL 2300 STAT PLUS
K913806 · Ysis, Inc. · Oct 1991
FIRST CHOICE(TM)
K912732 · Polymer Technology Corp. · Sep 1991
VISION BG TEST STRIP
K911624 · British-American Medical, Inc. · Jul 1991
VISION BG MONITOR
K911596 · British-American Medical, Inc. · May 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · Polymer Technology Corp. · May 1991
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
K911141 · Hemocue, Inc. · May 1991
K912440 · ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Download PDF Home Diagnostics, Inc.