Cleared Traditional

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K043341 · Bio-Rad Laboratories, Inc. · Immunology
Oct 2005
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K043341 is an FDA 510(k) clearance for the BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, a Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease (Class II — Special Controls, product code NVI), submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on October 27, 2005, 328 days after receiving the submission on December 3, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K043341 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2004
Decision Date October 27, 2005
Days to Decision 328 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code NVI — Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100
Definition The Device Is Intended To Suggest A Systemic Autoimmune Disease Association As An Aid For Differential Diagnosis To Be Evaluated In Conjunction With Clinical Findings And Other Laboratory Tests.