Cleared Traditional

K801007 - IL SYSTEM 502 NA/K ANALYZER

K801007 is an FDA 510(k) clearance for IL SYSTEM 502 NA/K ANALYZER, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801007 · Instrumentation Laboratory CO · Chemistry device
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May 1980
Decision
16d
Days
Class 2
Risk

K801007 is an FDA 510(k) clearance for the IL SYSTEM 502 NA/K ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K801007

510(k) Number K801007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date May 14, 1980
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 133
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K801007.
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · Nova Biomedical Corp. · Sep 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · Beckman Instruments, Inc. · Sep 1980
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM
K800676 · Diagnostic Solutions, Inc. · May 1980
KODAK EKTACHEM CLINICAL CHEM. SLIDES
K800628 · Eastman Kodak Company · Apr 1980
NSI SODIUM/POTASSIUM KIT
K800584 · Nobel Scientific Industries, Inc. · Apr 1980
SODIUM/POTASSIUM CONDITIONING REAGENT
K800216 · Fisher Scientific Co., LLC · Feb 1980