510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083868Substantially Equivalent

Architect Anti-Ccp (100 Test), Architect Anti-Ccp (500 Test), Models 1P65-25, 1P65-35

Axis-Shield Diagnostics, Ltd., Dundee, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083868 is the FDA 510(k) clearance record for ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35, a class II device, cleared for Axis-Shield Diagnostics, Ltd. on under FDA product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)). FDA's definition for product code NHX reads: "The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis". FDA records list 28 510(k) clearances for Axis-Shield Diagnostics, Ltd., from to . As of , FDA records show one recall naming K083868.

Clearance record

Decision date
Received
(270 days to decision)
Product code
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Axis-Shield Diagnostics, Ltd. The Technology Park, Dundee, GB
510(k) summary
Statement
Third party review
No

Clearances, product code NHX

Trailing 12 months

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

FDA records show no clearances under product code NHX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHX, 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