Cleared Traditional

K141073 - LIQUICHEK TUMOR MARKER CONTROL (FDA 510(k) Clearance)

Class I Immunology device.

K141073 · Bio-Rad Laboratories · Immunology device
Jun 2014
Decision
59d
Days
Class 1
Risk

K141073 is an FDA 510(k) clearance for the LIQUICHEK TUMOR MARKER CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on June 23, 2014 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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.

Submission Details

510(k) Number K141073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2014
Decision Date June 23, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
218d faster than avg
Panel avg: 277d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.