Cleared Traditional

K855046 - TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT

K855046 is an FDA 510(k) clearance for TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 253-day FDA review.

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

FDA 510(k) Submission Details - K855046

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.

CZP Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K855046.
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987
PRECIMAT (R) IGA, G, M
K863352 · Boehringer Mannheim Corp. · Sep 1986
TINA-QUANT(R) IGA
K862763 · Boehringer Mannheim Corp. · Sep 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · Dako Corp. · Aug 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · Kallestad Laboratories, Inc. · Feb 1986
CORNING IMMUNOFIXATION SYS
K843614 · Corning Medical & Scientific · Oct 1984