Cleared Traditional

K163015 - Liquichek Tumor Marker Control-Level 1 (FDA 510(k) Clearance)

Also includes:
Liquichek Tumor Marker Control-Level 2 Liquichek Tumor Marker Control-Level 3 Liquichek Tumor Marker Control- Trilevel MiniPak

Class I Immunology device.

K163015 · Bio-Rad Laboratories · Immunology device
Jan 2017
Decision
74d
Days
Class 1
Risk

K163015 is an FDA 510(k) clearance for the Liquichek Tumor Marker Control-Level 1. 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 January 10, 2017 after a review of 74 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 K163015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date January 10, 2017
Days to Decision 74 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
203d faster than avg
Panel avg: 277d · This submission: 74d
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.