Cleared Traditional

K960855 - PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL

K960855 is an FDA 510(k) clearance for PRESTIGE 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 251-day FDA review.

K960855 · Home Diagnostics, Inc. · Chemistry device
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Nov 1996
Decision
251d
Days
Class 2
Risk

K960855 is an FDA 510(k) clearance for the PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AN.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Ft Lauderdale, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 251 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 Home Diagnostics, Inc. devices

FDA 510(k) Submission Details - K960855

510(k) Number K960855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1996
Decision Date November 07, 1996
Days to Decision 251 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
163d slower than avg
Panel avg: 88d · This submission: 251d
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 303
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K960855.
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · Bayer Corp. · Feb 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · Bayer Corp. · Jan 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · Sigma Diagnostics, Inc. · Jan 1997
AMD HOME HEALTH MONITORING SYSTEM
K960337 · Advanced Medical Devices, Inc. · Sep 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
K961985 · Selfcare, Inc. · Sep 1996
SAFESTRIP
K955107 · Firehouse Medical, Inc. · Aug 1996