Cleared Traditional

K923129 - KING DIAGNOSTICS GLUCOSE (HK) REAGENT

K923129 is the FDA 510(k) clearance for KING DIAGNOSTICS GLUCOSE (HK) REAGENT by King Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K923129 · King Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
129d
Days
Class 2
Risk

K923129 is an FDA 510(k) clearance for the KING DIAGNOSTICS GLUCOSE (HK) REAGENT. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 129 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 King Diagnostics, Inc. devices

Submission Details

510(k) Number K923129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1992
Decision Date November 02, 1992
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K923129.
ROCHE COBAS FUTURA GLUCOSE
K922811 · Roche Diagnostic Systems, Inc. · Jan 1993
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
MILES URINE GLUCOSE METHOD
K923040 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS GLUCOSE REAGENT
K922232 · Olympus Corp. · Jul 1992