Cleared Traditional

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT (K872800) - FDA 510(k) Clearance

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

K872800 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
28d
Days
Class 2
Risk

K872800 is an FDA 510(k) clearance for the TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT. 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 August 12, 1987 after a review of 28 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

Submission Details

510(k) Number K872800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1987
Decision Date August 12, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K872800.
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · Zeus Scientific, Inc. · Dec 1992
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · Technicon Instruments Corp. · Apr 1990
WAKO(TM) IGG-HA DIRECT
K880784 · Wako Chemicals USA, Inc. · Jun 1988
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGG
K862764 · Boehringer Mannheim Corp. · Sep 1986
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · Abbott Laboratories · Jul 1985