Cleared Traditional

K852414 - LYPHOCHEK DRUG FREE SERUM(HUMAN)

K852414 is the FDA 510(k) clearance for LYPHOCHEK DRUG FREE SERUM(HUMAN) by Bio-Rad. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K852414 · Bio-Rad · Toxicology device
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Jul 1985
Decision
48d
Days
Class 1
Risk

K852414 is an FDA 510(k) clearance for the LYPHOCHEK DRUG FREE SERUM(HUMAN). Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on July 24, 1985 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology 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 Bio-Rad devices

Submission Details

510(k) Number K852414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date July 24, 1985
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K852414.
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919 · Fisher Scientific Co., LLC · Apr 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · Instrumentation Laboratory CO · Feb 1986
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · Quantimetrix Corp. · Oct 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945 · Syva Co. · Jan 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946 · Syva Co. · Jan 1985
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818 · Quantimetrix Corp. · Oct 1984