Cleared Traditional

TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT (K855046) - FDA 510(k) Clearance

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

K855046 · Abbott Laboratories · Immunology device
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Aug 1986
Decision
253d
Days
Class 2
Risk

K855046 is an FDA 510(k) clearance for the TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on August 27, 1986 after a review of 253 days - an extended review 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: 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 Abbott Laboratories devices

Submission Details

510(k) Number K855046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date August 27, 1986
Days to Decision 253 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
149d slower than avg
Panel avg: 104d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, 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 - CZP Iga, Antigen, Antiserum, Control

All 26
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K855046.
WAKO(TM) IGA-HA DIRECT
K880803 · Wako Chemicals USA, Inc. · Mar 1988
PRECIMAT (R) IGA, G, M
K863352 · Boehringer Mannheim Corp. · Sep 1986
TINA-QUANT(R) IGA
K862763 · Boehringer Mannheim Corp. · Sep 1986
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · Miles Laboratories, Inc. · Aug 1984
IMMUNOGLOBULIN CONTROL
K823566 · Syva Co. · Dec 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567 · Syva Co. · Dec 1982