510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081338Substantially Equivalent

Roche Elecsys Anti-Ccp Immunoassay, Roche Elecsys Precicontrol Anti-Ccp

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081338 is the FDA 510(k) clearance record for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP, a class II device, cleared for Roche Diagnostics 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 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show 2 recalls naming K081338.

Clearance record

Decision date
Received
(121 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
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
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