Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease
Device Code: 3118
Product Code(s):
NVI 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.
Device Classification Information
| Device Type ID | 3118 |
| Device Name | Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease |
| Regulation Description | Amphetamine Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3118 |
| Device | Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease |
| Product Code | NVI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Amphetamine Test System. |
| CFR Regulation Number | 862.3100 [🔎] |
TPLC Last Update: 2019-04-02 20:24:07