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Medical Disclaimer

Effective Date: January 1, 2026 · Last Updated: March 2026

Important Notice

Vancomyzer™ is a clinical decision support tool for use by licensed healthcare professionals only. It is not intended for use by patients, caregivers, or individuals without appropriate clinical training in pharmacokinetics and therapeutic drug monitoring.

Vancomyzer™ is not intended to replace clinical judgment. All dosing recommendations generated by this software must be independently verified by a qualified clinician before being applied to patient care. The software provides decision support only and does not constitute medical advice, diagnosis, or treatment.

Vancomyzer™ is not FDA-cleared as a medical device. It is classified as non-device clinical decision support software under the 21st Century Cures Act, Section 3060 (21 U.S.C. §360j(o)).

All dosing recommendations must be independently verified by a qualified clinician. Dosys Health LLC and its officers, employees, and agents shall not be liable for any clinical decisions made based on information provided by Vancomyzer™.

Regulatory Classification

Vancomyzer™ is classified as non-device clinical decision support (CDS) softwareunder the 21st Century Cures Act, Section 3060. Under this provision, software that meets all four criteria of the non-device CDS test is excluded from the definition of a “device” under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

No FDA 510(k) clearance is required for software that satisfies all four factors of the non-device CDS test.

Four-Factor Non-Device CDS Test

Vancomyzer™ satisfies each of the four criteria required for non-device CDS classification:

1

Not intended to acquire, process, or analyze a medical image or signal

Vancomyzer™ does not interface with any medical imaging or diagnostic device. All patient data (age, weight, serum creatinine, drug levels) is manually entered by the clinician.

2

Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information

Vancomyzer™ displays pharmacokinetic calculations, dosing recommendations, and concentration-time profiles based on published population PK models.

3

Intended for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment

Vancomyzer™ is designed so that the healthcare professional can independently review the basis for all recommendations. Every PK equation, model parameter, and assumption is displayed alongside DOI-linked references to the published literature.

4

Not intended to replace the clinical judgment of a healthcare professional

Vancomyzer™ provides dosing recommendations as decision support only. All dosing decisions must be independently verified and approved by a qualified healthcare professional.

Clinical Model & Limitations

Vancomyzer™ uses the Colin PJ et al. (2019) two-compartment population pharmacokinetic model for vancomycin. This model has been published and peer-reviewed. Model-informed precision dosing with Bayesian PK models has been shown to improve clinical outcomes (Hall et al., 2024).

The model has known limitations:

  • Not validated for patients on renal replacement therapy (RRT), including hemodialysis, CRRT, or peritoneal dialysis. Vancomyzer™ includes an automatic RRT safety block.
  • Not validated for pediatric patients under 18 years of age (the Colin 2019 model includes pediatric data, but Vancomyzer v1.0 is configured for adult patients only).
  • Accuracy depends on the quality and timing of input data. Serum creatinine values should reflect current renal function. Drug levels should be drawn at appropriate times relative to dosing.
  • Population PK models provide estimates based on population-level data. Individual patient pharmacokinetics may differ from model predictions.

Limitation of Liability

Dosys Health LLC provides Vancomyzer™ “as is” and makes no warranties, express or implied, regarding the accuracy, completeness, reliability, or suitability of the software for any particular purpose.

In no event shall Dosys Health LLC, its founders, officers, employees, agents, or advisors be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising from the use of or inability to use Vancomyzer™, including but not limited to damages for loss of profits, data, or patient outcomes.

By using Vancomyzer™, the healthcare professional acknowledges that they have read, understood, and agree to this disclaimer, and that they accept full clinical responsibility for all dosing decisions made in the care of their patients.

References

Questions about this disclaimer? Contact us at legal@dosys.health or visit our Science & Methodology page for detailed technical documentation.