Cleared Traditional

K033910 - OLYMPUS URINE CALIBRATOR

K033910 is the FDA 510(k) clearance for OLYMPUS URINE CALIBRATOR by Cliniqa Corporation. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K033910 · Cliniqa Corporation · Chemistry device
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Jan 2004
Decision
44d
Days
Class 2
Risk

K033910 is an FDA 510(k) clearance for the OLYMPUS URINE CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on January 30, 2004 after a review of 44 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 Cliniqa Corporation devices

Submission Details

510(k) Number K033910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2003
Decision Date January 30, 2004
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
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 226
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K033910.
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
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K033380 · Bayer Diagnostics Corp. · Dec 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · Olympus America, Inc. · Nov 2003
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K033501 · Roche Diagnostics Corp. · Nov 2003