Cleared Traditional

K852676 - IL SYSTEM 1304 & 1306

K852676 is the FDA 510(k) clearance for IL SYSTEM 1304 & 1306 by Allied Instrumentation Laboratory. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K852676 · Allied Instrumentation Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
28d
Days
Class 2
Risk

K852676 is an FDA 510(k) clearance for the IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Allied Instrumentation Laboratory (Lexington, US). The FDA issued a Cleared decision on July 22, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Allied Instrumentation Laboratory devices

Submission Details

510(k) Number K852676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1985
Decision Date July 22, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 132
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K852676.
LIFE WATCH RESPIRATORY MONITOR
K853840 · The Perkin-Elmer Corp. · Dec 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · Nova Biomedical Corp. · Dec 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790 · Nova Biomedical Corp. · Nov 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781 · Shaban Mfg. Co. · Feb 1985
ABL300 ACID BASE LABORATORY
K844295 · Radiometer America, Inc. · Dec 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609 · Shaban Mfg. Co. · May 1984