Cleared Traditional

KING DIAGNOSTICS GLUCOSE (HK) REAGENT (K923129) - FDA 510(k) Clearance

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

K923129 · King Diagnostics, Inc. · Chemistry device
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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
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 144
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K923129.
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cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics · Sep 2022
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K191899 · Roche Diagnostics · Aug 2019
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · Beckman Coulter, Inc. · Apr 2014