Cleared Traditional

K930199 - ALKO FLUIDS PACKS FOR NOVA ANALYZERS

K930199 is an FDA 510(k) clearance for ALKO FLUIDS PACKS FOR NOVA ANALYZERS, manufactured by Alko Diagnostic Corp.. The device is a Class 2 Toxicology device with product code JIX cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K930199 · Alko Diagnostic Corp. · Toxicology device
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Jan 1994
Decision
364d
Days
Class 2
Risk

K930199 is an FDA 510(k) clearance for the ALKO FLUIDS PACKS FOR NOVA ANALYZERS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on January 13, 1994 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1150 - the FDA toxicology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alko Diagnostic Corp. devices

FDA 510(k) Submission Details - K930199

510(k) Number K930199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date January 13, 1994
Days to Decision 364 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 87d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Toxicology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 272
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K930199.
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ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
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QUANTIMETRIX BLOOD GLUCOSE CONTROLS
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