Cleared Traditional

K905600 - TECHLYTE ELECTROLYTE ANALYZER

K905600 is an FDA 510(k) clearance for TECHLYTE ELECTROLYTE ANALYZER, manufactured by Technalysis, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K905600 · Technalysis, Inc. · Chemistry device
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Jan 1991
Decision
32d
Days
Class 2
Risk

K905600 is an FDA 510(k) clearance for the TECHLYTE ELECTROLYTE ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Technalysis, Inc. (Austin, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Technalysis, Inc. devices

FDA 510(k) Submission Details - K905600

510(k) Number K905600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date January 15, 1991
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. 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 117
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K905600.
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · Instrumentation Laboratory CO · Jun 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · Baxter Healthcare Corp · Mar 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
K905264 · Nova Biomedical Corp. · Mar 1991
SECONDARY CALIBRATORS
K904335 · Bionostics, Inc. · Oct 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
IONOMETER EF-HK AND ACCESSORIES
K901042 · Fresenius USA, Inc. · Jul 1990