Devices · BIO-RAD LABORATORIES, INC.

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

BIO-RAD LABORATORIES, INC. is listed for BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341). The FDA list gives October 27, 2005 as the date of the final decision. The lead panel is Clinical Toxcicology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code NVI as “Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K043341

Official FDA database record

Date of final decision

October 27, 2005

Company on the FDA list

BIO-RAD LABORATORIES, INC.

Lead panel

Clinical Toxcicology

Primary product code

NVI

openFDA device name for the code

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Device class

2

Regulation number

862.3100

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary