Cleared Traditional

K030074 - LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030074 · Cliniqa Corporation · Immunology device
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Jan 2003
Decision
13d
Days
Class 2
Risk

K030074 is an FDA 510(k) clearance for the LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCH.... 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 21, 2003 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology 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: 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 K030074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date January 21, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 104d · This submission: 13d
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 Immunology devices follow this clearance model.