Cleared Traditional

F/LS MCA APPLICATION SOFTWARE (K801456) - FDA 510(k) Clearance

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

K801456 · Instrumentation Laboratory CO · Immunology device
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Oct 1980
Decision
101d
Days
Class 2
Risk

K801456 is an FDA 510(k) clearance for the F/LS MCA APPLICATION SOFTWARE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1345 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K801456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date October 03, 1980
Days to Decision 101 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 104d · This submission: 101d
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 Immunology 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 K801456.
Glucose HK Gen.3
K253490 · Roche Diagnostics · Feb 2026
Glucose2
K252357 · Abbott Ireland · Oct 2025
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
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899 · Roche Diagnostics · Aug 2019
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
GLUCOSE
K060383 · Abbott Laboratories · May 2006