Cleared Traditional

K200544 - SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

K200544 is an FDA 510(k) clearance for SmartLyte Plus Electrolyte Analyzer Na+..., manufactured by Diamond Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K200544 · Diamond Diagnostics, Inc. · Chemistry device
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Oct 2020
Decision
212d
Days
Class 2
Risk

K200544 is an FDA 510(k) clearance for the SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on October 1, 2020 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diamond Diagnostics, Inc. devices

FDA 510(k) Submission Details - K200544

510(k) Number K200544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date October 01, 2020
Days to Decision 212 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
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 66
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