Cleared Traditional

MILES URINE GLUCOSE METHOD (K923040) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923040 · Heraeus Kulzer, Inc. · Chemistry device
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Sep 1992
Decision
88d
Days
Class 2
Risk

K923040 is an FDA 510(k) clearance for the MILES URINE GLUCOSE METHOD. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 15, 1992 after a review of 88 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.

View all Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K923040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1992
Decision Date September 15, 1992
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K923040.
OLYMPUS GLUCOSE REAGENT
K924601 · Olympus Corp. · Dec 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572 · Em Diagnostic Systems, Inc. · Nov 1992
ENCORE TEST STRIPS
K923018 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS GLUCOSE REAGENT
K922232 · Olympus Corp. · Jul 1992
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · Heraeus Kulzer, Inc. · Dec 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · Em Diagnostic Systems, Inc. · Jul 1991