Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tru Kidney Health Test Panel; Tru Analyzer

K-Number: K251058 · 2025-11-26

ApplicantTruvian Health
Decision Date2025-11-26
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tru Kidney Health Test Panel; Tru Analyzer is a medical device manufactured by Truvian Health. It received FDA 510(k) clearance on 2025-11-26 under approval number K251058. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tru Kidney Health Test Panel; Tru Analyzer?

Tru Kidney Health Test Panel; Tru Analyzer is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Truvian Health. The 510(k) number is K251058.

When was Tru Kidney Health Test Panel; Tru Analyzer approved by the FDA?

Tru Kidney Health Test Panel; Tru Analyzer received FDA 510(k) clearance on 2025-11-26, under approval number K251058.

What company makes Tru Kidney Health Test Panel; Tru Analyzer?

Tru Kidney Health Test Panel; Tru Analyzer is manufactured by Truvian Health.

What is the FDA product code for Tru Kidney Health Test Panel; Tru Analyzer?

The FDA product code for Tru Kidney Health Test Panel; Tru Analyzer is CGX.

Related Clinical Trials

NCT07593456 NST-SPARK Open-Label Phase 1 STTR (IGNITE) NOT_YET_RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT06815120 A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent RECRUITING NCT07561957 A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines RECRUITING NCT06410755 Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application ACTIVE_NOT_RECRUITING NCT06832696 Assessment of a Wearable Ultrafiltration Device NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42167878 Comparative effectiveness of sulfonylureas on kidney outcomes in adults with type 2 diabetes and moderate cardiovascular risk: a target trial emulation. BMJ open diabetes research & care (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

Other Devices by Truvian Health

K251091Lipids K251074Tru Liver Health Test Panel K251157Core Metabolic

Related Devices (Code: CGX)

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. K210452Creatinine2Abbott Ireland Diagnostics Division K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑