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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3100. 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..
| 510(k) Number | K043341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |