Cleared Traditional

K972861 - IL TEST CONTRIL SPECTRUM (LEVELS 1

K972861 is the FDA 510(k) clearance for IL TEST CONTRIL SPECTRUM (LEVELS 1 by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K972861 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
15d
Days
Class 1
Risk

K972861 is an FDA 510(k) clearance for the IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3). Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 19, 1997 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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

Submission Details

510(k) Number K972861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1997
Decision Date August 19, 1997
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJS Controls For Blood-gases, (assayed And Unassayed)

All 27
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K972861.
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535 · Bio-Rad · Aug 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
K002536 · Bio-Rad · Aug 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · Bio-Rad · Aug 2000
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · Nova Biomedical Corp. · Jul 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · Ciba Corning Diagnostics Corp. · Jan 1995
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · American Dade · Jul 1987