BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM is an AI-enabled medical device from BIO-RAD LABORATORIES, INC. that the U.S. FDA cleared through 510(k) K043341 on October 27, 2005. Its lead review panel is Clinical Toxcicology and its primary product code is NVI (Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease).
Key facts
| Submission number | K043341 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | BIO-RAD LABORATORIES, INC. |
| Lead review panel | Clinical Toxcicology |
| Primary product code | NVI — Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease |
| Applicant (openFDA) | Bio-Rad Laboratories, Inc. |
| Applicant location | Redmond, WA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.3100 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM went through this pathway (K043341).
openFDA lists it as a Class 2 device under 21 CFR 862.3100. Class II devices are moderate risk and are subject to general and special controls.
Product code NVI covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. BIO-RAD LABORATORIES, INC. has 1 AI-enabled device on the list, and the Clinical Toxcicology panel accounts for 5 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.