Cleared Traditional

K863333 - AVL ISE-TROL ELECTROLYTE CONTROL

K863333 is the FDA 510(k) clearance for AVL ISE-TROL ELECTROLYTE CONTROL by Avl Scientific Corp.. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K863333 · Avl Scientific Corp. · Chemistry device
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Sep 1986
Decision
32d
Days
Class 1
Risk

K863333 is an FDA 510(k) clearance for the AVL ISE-TROL ELECTROLYTE CONTROL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 32 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 Avl Scientific Corp. devices

Submission Details

510(k) Number K863333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1986
Decision Date September 29, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (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 - JJR Electrolyte Controls (assayed And Unassayed)

All 9
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K863333.
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · Baxter Healthcare Corp · Oct 1989
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · Casco Standards · Jun 1988
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505 · Quantimetrix Corp. · Apr 1984