Cleared Traditional

K925612 - HI CHEM ELECTROLYTE BUFFER

K925612 is an FDA 510(k) clearance for HI CHEM ELECTROLYTE BUFFER, manufactured by Hichem Diagnostics. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K925612 · Hichem Diagnostics · Chemistry device
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Apr 1993
Decision
166d
Days
Class 2
Risk

K925612 is an FDA 510(k) clearance for the HI CHEM ELECTROLYTE BUFFER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 166 days - an extended review 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: 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 Hichem Diagnostics devices

FDA 510(k) Submission Details - K925612

510(k) Number K925612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date April 20, 1993
Days to Decision 166 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
78d slower than avg
Panel avg: 88d · This submission: 166d
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 135
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K925612.
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