Cleared Traditional

K891680 - LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II (FDA 510(k) Clearance)

Class I Immunology device.

K891680 · Bio-Rad · Immunology device
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Jun 1989
Decision
84d
Days
Class 1
Risk

K891680 is an FDA 510(k) clearance for the LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 13, 1989 after a review of 84 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.

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Submission Details

510(k) Number K891680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1989
Decision Date June 13, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 104d · This submission: 84d
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.