Cleared Traditional

K923018 - ENCORE TEST STRIPS

K923018 is an FDA 510(k) clearance for ENCORE TEST STRIPS, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K923018 · Heraeus Kulzer, Inc. · Chemistry device
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Sep 1992
Decision
92d
Days
Class 2
Risk

K923018 is an FDA 510(k) clearance for the ENCORE TEST STRIPS. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 92 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 - K923018

510(k) Number K923018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date September 23, 1992
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 138
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K923018.
OLYMPUS GLUCOSE REAGENT
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K924572 · Em Diagnostic Systems, Inc. · Nov 1992
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · King Diagnostics, Inc. · Nov 1992
MILES URINE GLUCOSE METHOD
K923040 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS GLUCOSE REAGENT
K922232 · Olympus Corp. · Jul 1992
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · Heraeus Kulzer, Inc. · Dec 1991