K251157 is an FDA 510(k) clearance for the Core Metabolic. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II - Special Controls, product code CIX).
Submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on January 9, 2026, 269 days after receiving the submission on April 15, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K251157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIX - Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |