Cleared Traditional

K991166 - K-ASSAY MICROALBUMIN CALIBRATOR SET

K991166 is the FDA 510(k) clearance for K-ASSAY MICROALBUMIN CALIBRATOR SET by Kamiya Biomedical Co.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K991166 · Kamiya Biomedical Co. · Chemistry device
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Jun 1999
Decision
64d
Days
Class 2
Risk

K991166 is an FDA 510(k) clearance for the K-ASSAY MICROALBUMIN CALIBRATOR SET. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on June 10, 1999 after a review of 64 days - a notably fast clearance cycle.

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: 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K991166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date June 10, 1999
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K991166.
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