Cleared Traditional

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020823 · Sanquin Blood Supply Foundation · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
61d
Days
Class 2
Risk

K020823 is an FDA 510(k) clearance for the PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT. Classified as Igg (gamma Chain Specific), Antigen, Antiserum, Control (product code DFZ), Class II - Special Controls.

Submitted by Sanquin Blood Supply Foundation (Great Neck, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Sanquin Blood Supply Foundation devices

Submission Details

510(k) Number K020823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2002
Decision Date May 14, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 104d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFZ Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.