Cleared Traditional

K921575 - IGG SUCLASS EIA

K921575 is an FDA 510(k) clearance for IGG SUCLASS EIA, manufactured by Virotech Diagnostika. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K921575 · Virotech Diagnostika · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
56d
Days
Class 2
Risk

K921575 is an FDA 510(k) clearance for the IGG SUCLASS EIA. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Virotech Diagnostika (West Cadwell, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 56 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 Virotech Diagnostika devices

FDA 510(k) Submission Details - K921575

510(k) Number K921575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date May 28, 1992
Days to Decision 56 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
49d faster than avg
Panel avg: 105d · This submission: 56d
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 K921575.
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