Cleared Traditional

K924197 - ZORBA(TM) IGG REMOVAL REAGENT

K924197 is an FDA 510(k) clearance for ZORBA(TM) IGG REMOVAL REAGENT, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K924197 · Zeus Scientific, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
117d
Days
Class 2
Risk

K924197 is an FDA 510(k) clearance for the ZORBA(TM) IGG REMOVAL REAGENT. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K924197

510(k) Number K924197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date December 15, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 104d · This submission: 117d
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 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K924197.
BEHRING NEPHELOMETER II
K943997 · Behring Diagnostics, Inc. · Oct 1994
OT IGG SORBENT
K934324 · Organon Teknika Corp. · Apr 1994
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · Bio-Rad · Sep 1993
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · Technicon Instruments Corp. · Apr 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · Vitek Systems, Inc. · Apr 1989
QM300 IGG ANTIBODY PACK
K882083 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988