Cleared Traditional

HUMAN C5 RID KITS (K942326) - FDA 510(k) Clearance

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

K942326 · Jay H. Geller · Immunology device
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Aug 1995
Decision
468d
Days
Class 2
Risk

K942326 is an FDA 510(k) clearance for the HUMAN C5 RID KITS. Classified as Complement C5, Antigen, Antiserum, Control (product code DAY), Class II - Special Controls.

Submitted by Jay H. Geller (Santa Monica, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Jay H. Geller devices

Submission Details

510(k) Number K942326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1994
Decision Date August 24, 1995
Days to Decision 468 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
364d slower than avg
Panel avg: 104d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAY Complement C5, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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.