Cleared Traditional

K843453 - ULTRA LYTE SODIUM REAGENT KIT

K843453 is an FDA 510(k) clearance for ULTRA LYTE SODIUM REAGENT KIT, manufactured by Ultra Quest Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K843453 · Ultra Quest Diagnostics, Inc. · Chemistry device
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Nov 1984
Decision
83d
Days
Class 2
Risk

K843453 is an FDA 510(k) clearance for the ULTRA LYTE SODIUM REAGENT KIT. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Ultra Quest Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 83 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 Ultra Quest Diagnostics, Inc. devices

FDA 510(k) Submission Details - K843453

510(k) Number K843453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date November 27, 1984
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 88d · This submission: 83d
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 137
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K843453.
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