Cleared Traditional

K801456 - F/LS MCA APPLICATION SOFTWARE

K801456 is an FDA 510(k) clearance for F/LS MCA APPLICATION SOFTWARE, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code CFR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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.

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FDA 510(k) Submission Details - K801456

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 105d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K801456.
GLUCOSE-HK SYSTEM PACK TEST
K812303 · Boehringer Mannheim Corp. · Sep 1981
ESKAFLOW TEST FOR GLUCOSE
K811849 · Smithkline Diagnostics, Inc. · Jul 1981
HEXOKINASE, GLUCOSE
K802810 · Beckman Instruments, Inc. · Dec 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · Reagents Applications, Inc. · Sep 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · Data Medical Associates, Inc. · May 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · Data Medical Associates, Inc. · May 1980