Cleared Traditional

K861167 - IMMUNOGLOBULINS A

K861167 is the FDA 510(k) clearance for IMMUNOGLOBULINS A by Atlantic Antibodies. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K861167 · Atlantic Antibodies · Immunology device
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Apr 1986
Decision
28d
Days
Class 2
Risk

K861167 is an FDA 510(k) clearance for the IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on April 25, 1986 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 Atlantic Antibodies devices

Submission Details

510(k) Number K861167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date April 25, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 K861167.
TINA-QUANT(R) IGA
K862763 · Boehringer Mannheim Corp. · Sep 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · Abbott Laboratories · Aug 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
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · Miles Laboratories, Inc. · Aug 1984