Cleared Traditional

K885224 - ANA-5 AUTOANTIBODY PROFILE KIT

K885224 is an FDA 510(k) clearance for ANA-5 AUTOANTIBODY PROFILE KIT, manufactured by Autoimmunity Diagnostics Corp.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K885224 · Autoimmunity Diagnostics Corp. · Immunology device
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Apr 1989
Decision
115d
Days
Class 2
Risk

K885224 is an FDA 510(k) clearance for the ANA-5 AUTOANTIBODY PROFILE KIT. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Autoimmunity Diagnostics Corp. (Lake Villa, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Autoimmunity Diagnostics Corp. devices

FDA 510(k) Submission Details - K885224

510(k) Number K885224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date April 14, 1989
Days to Decision 115 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 105d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LKJ Antinuclear Antibody, Antigen, Control

All 38
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K885224.
AUTOSTAT(TM) ANTI-DSNA
K913342 · Cogent Diagnotics , Ltd. · May 1992
DISTAT ANTI-SCL-70 KIT
K912291 · Shield Diagnostics, Ltd. · Jul 1991
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · Sigma Diagnostics, Inc. · Nov 1987