Cleared Traditional

K924499 - ELITE TEST STRIPS GLUCOMETER

K924499 is an FDA 510(k) clearance for ELITE TEST STRIPS GLUCOMETER, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K924499 · Heraeus Kulzer, Inc. · Chemistry device
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Dec 1992
Decision
104d
Days
Class 2
Risk

K924499 is an FDA 510(k) clearance for the ELITE TEST STRIPS GLUCOMETER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 104 days - within the typical 510(k) review window.

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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K924499

510(k) Number K924499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date December 17, 1992
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 206
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K924499.
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · Heraeus Kulzer, Inc. · Jun 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · Hichem Diagnostics · Apr 1993
ONE TOUCH TEST STRIPS
K923544 · Lifescan, Inc. · Dec 1992
NOVA 12 ANALYZER, MODIFICATION
K924743 · Nova Biomedical Corp. · Nov 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · Boehringer Mannheim Corp. · Oct 1992