Cleared Traditional

MEDISENSOR 2001 (K903564) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903564 · Medtest Systems, Inc. · Chemistry device
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Sep 1991
Decision
419d
Days
Class 2
Risk

K903564 is an FDA 510(k) clearance for the MEDISENSOR 2001. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Medtest Systems, Inc. (College Park, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Medtest Systems, Inc. devices

Submission Details

510(k) Number K903564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date September 30, 1991
Days to Decision 419 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 88d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K903564.
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · Beckman Coulter, Inc. · May 2001
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627 · Roche Diagnostic Systems, Inc. · Oct 1996
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · Eastman Kodak Company · Nov 1992
ISE/NA+
K912648 · Boehringer Mannheim Corp. · Jul 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · Instrumentation Laboratory CO · Jun 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · Baxter Healthcare Corp · Mar 1991