510(k) K043341
K043341 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 2005. The device falls under product code NVI (Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease), a Class II device regulated under 21 CFR 862.3100. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2005
- Date Received
- December 3, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- IM
- Submission Type
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.