DeviceClearance

Product code NVI— Clinical Toxicology

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

Classification name
Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Device class
Class 2
Regulation
21 CFR 862.3100
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NVI under 21 CFR 862.3100, via openFDA

Market context for product code NVI

FDA has cleared 1 device under product code NVI, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NVI

Recent clearances under product code NVI

Data sourced from openFDA. This site is unofficial and independent of the FDA.