Cleared Traditional

K172232 - LIASYS 600 Electrolyte Measurement System

K172232 is the FDA 510(k) clearance for LIASYS 600 Electrolyte Measurement System by Ams Diagnostics. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 687-day FDA review.

K172232 · Ams Diagnostics · Chemistry device
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Jun 2019
Decision
687d
Days
Class 2
Risk

K172232 is an FDA 510(k) clearance for the LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIA.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Ams Diagnostics (Weston, US). The FDA issued a Cleared decision on June 12, 2019 after a review of 687 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.

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Submission Details

510(k) Number K172232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date June 12, 2019
Days to Decision 687 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
599d slower than avg
Panel avg: 88d · This submission: 687d
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 107
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