Cleared Traditional

K874846 - GLUCOSE (HEXOKINASE)

K874846 is the FDA 510(k) clearance for GLUCOSE (HEXOKINASE) by Tech-Co, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K874846 · Tech-Co, Inc. · Chemistry device
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Mar 1988
Decision
100d
Days
Class 2
Risk

K874846 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 100 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 Tech-Co, Inc. devices

Submission Details

510(k) Number K874846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date March 03, 1988
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
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 110
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K874846.
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · Em Diagnostic Systems, Inc. · Jan 1989
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · Em Diagnostic Systems, Inc. · Nov 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · Abbott Laboratories · Aug 1988
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · Baxter Healthcare Corp · Nov 1987
GLUCOSE HK PROCEDURE
K863259 · Data Medical Associates, Inc. · Sep 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · Sterling Diagnostics, Inc. · Apr 1986