Cleared Traditional

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

K021516 · Axis-Shield Diagnostics, Ltd. · Immunology

Jul 2002

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K021516 is an FDA 510(k) clearance for the DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on July 23, 2002, 74 days after receiving the submission on May 10, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K021516 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2002
Decision Date	July 23, 2002
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	NHX — Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5775
Definition	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.