510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885224Substantially Equivalent

Ana-5 Autoantibody Profile Kit

Autoimmunity Diagnostics Corp., Lake Villa IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885224 is the FDA 510(k) clearance record for ANA-5 AUTOANTIBODY PROFILE KIT, a class II device, cleared for Autoimmunity Diagnostics Corp. on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list one 510(k) clearance for Autoimmunity Diagnostics Corp. As of , FDA records show no recalls naming K885224.

Clearance record

Decision date
Received
(115 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Autoimmunity Diagnostics Corp. 67 Kevin Ave., Lake Villa IL
Third party review
No

Clearances, product code LKJ

Trailing 12 months

FDA records hold no clearances under product code LKJ in the trailing twelve months.

FDA records show no clearances under product code LKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260