Cleared Traditional

K042324 - LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CO...

K042324 is the FDA 510(k) clearance for LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CO... by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K042324 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
41d
Days
Class 1
Risk

K042324 is an FDA 510(k) clearance for the LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on October 7, 2004 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Bio-Rad devices

Submission Details

510(k) Number K042324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2004
Decision Date October 07, 2004
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K042324.
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
K042318 · Aalto Scientific, Ltd. · Dec 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · Bio-Rad Laboratories, Inc. · Dec 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · Bio-Rad · Nov 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · Bio-Rad Laboratories, Inc. · Sep 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K042389 · Roche Diagnostics Corp. · Sep 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
K041812 · Roche Diagnostics Corp. · Jul 2004