Cleared Traditional

K911610 - ELISA COMBI-KIT HUMAN IGG SUBCLASSES

K911610 is an FDA 510(k) clearance for ELISA COMBI-KIT HUMAN IGG SUBCLASSES, manufactured by Janssen Research Foundation. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K911610 · Janssen Research Foundation · Immunology device
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Jun 1991
Decision
79d
Days
Class 2
Risk

K911610 is an FDA 510(k) clearance for the ELISA COMBI-KIT HUMAN IGG SUBCLASSES. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Janssen Research Foundation (Piscataway, US). The FDA issued a Cleared decision on June 12, 1991 after a review of 79 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 Janssen Research Foundation devices

FDA 510(k) Submission Details - K911610

510(k) Number K911610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date June 12, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 105d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, 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.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 58
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K911610.
OT IGG SORBENT
K934324 · Organon Teknika Corp. · Apr 1994
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · Bio-Rad · Sep 1993
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · Zeus Scientific, Inc. · Dec 1992
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · Technicon Instruments Corp. · Apr 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · Vitek Systems, Inc. · Apr 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · Atlantic Antibodies · Feb 1989