Cleared Traditional

K925464 - CALIBRATION SOLUTIONS FOR USE ON ELECTR...

K925464 is an FDA 510(k) clearance for CALIBRATION SOLUTIONS FOR USE ON ELECTR..., manufactured by Alko Diagnostic Corp.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K925464 · Alko Diagnostic Corp. · Chemistry device
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Jan 1994
Decision
441d
Days
Class 2
Risk

K925464 is an FDA 510(k) clearance for the CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR. 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 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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.

View all Alko Diagnostic Corp. devices

FDA 510(k) Submission Details - K925464

510(k) Number K925464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1992
Decision Date January 13, 1994
Days to Decision 441 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
353d slower than avg
Panel avg: 88d · This submission: 441d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 230
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