Cleared Traditional

K983221 - IGG

K983221 is an FDA 510(k) clearance for IGG, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K983221 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
51d
Days
Class 2
Risk

K983221 is an FDA 510(k) clearance for the IGG. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 51 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K983221

510(k) Number K983221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date November 04, 1998
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 104d · This submission: 51d
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 K983221.
SPIFE IFE CALIBRATOR AND CONTROL KIT
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K993928 · Wako Chemicals USA, Inc. · Jan 2000
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K993281 · Kamiya Biomedical Co. · Nov 1999
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K963974 · Beckman Instruments, Inc. · Mar 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · Beckman Instruments, Inc. · Feb 1997