Cleared Special

K992988 - PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM

K992988 is an FDA 510(k) clearance for PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM, manufactured by Home Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 21-day FDA review.

K992988 · Home Diagnostics, Inc. · Chemistry device
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Sep 1999
Decision
21d
Days
Class 2
Risk

K992988 is an FDA 510(k) clearance for the PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K992988

510(k) Number K992988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date September 24, 1999
Days to Decision 21 days
Submission Type Special
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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K992988.
AVL OPTI CRITICAL CARE ANALYZER
K993837 · Avl Scientific Corp. · Dec 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · Health Hero Network, Inc. · Nov 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632 · Selfcare, Inc. · Nov 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · Selfcare, Inc. · Sep 1999
GO GLUCOSE MONITORING SYSTEM
K991754 · Lxn Corp. · Sep 1999
DUET II GLUCOSE CONTROL MONITORING SYSTEM
K990942 · Lxn Corp. · Aug 1999
K992988 · PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
Download PDF Home Diagnostics, Inc.