Cleared Traditional

K082036 - LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (FDA 510(k) Clearance)

Class I Immunology device.

K082036 · Bio-Rad Laboratories · Immunology device
Sep 2008
Decision
53d
Days
Class 1
Risk

K082036 is an FDA 510(k) clearance for the LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK. 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 September 8, 2008 after a review of 53 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 K082036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date September 08, 2008
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
224d faster than avg
Panel avg: 277d · This submission: 53d
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.