Cleared Traditional

RANDOX PREALBUMIN (K000661) - FDA 510(k) Clearance

Class I Immunology device.

K000661 · Randox Laboratories, Ltd. · Immunology device
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Apr 2000
Decision
45d
Days
Class 1
Risk

K000661 is an FDA 510(k) clearance for the RANDOX PREALBUMIN. Classified as Prealbumin, Antigen, Antiserum, Control (product code JZJ), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on April 13, 2000 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - 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.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K000661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date April 13, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 104d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZJ Prealbumin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
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.