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hemodialysis concentrate
Dana Laboratories
Summary: Hemodialysis concentrate by Dana Laboratories is used in dialysis treatments to maintain electrolyte balance. Key evidence includes studies on emergency dialysate production and dextrose determination methods.
FDA Clearance Information
Pathway
510K
Number
K854391 ↗
Decision Date
January 8, 1986
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The hemodialysis concentrate by Dana Laboratories was cleared through the FDA 510k pathway on January 8, 1986. It is classified as a Class 2 device under product code FKQ.
What It Is
The hemodialysis concentrate is a solution used in dialysis to help remove waste products and excess fluid from the blood. It is essential for maintaining electrolyte balance during hemodialysis treatments.
Clinical Applications
Commonly used in patients with chronic kidney disease requiring dialysis, the concentrate is vital for effective hemodialysis sessions. It ensures the correct composition of dialysate to facilitate waste removal.
Evidence Summary
The literature includes 8 studies, ranging from 1978 to 2023, covering topics like emergency dialysate production and dextrose determination. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report the successful implementation of emergency dialysate production during supply chain disruptions. Other studies focus on the analytical methods for determining dextrose levels in dialysis solutions.
Safety Profile
Reported complications include potential supply chain disruptions affecting availability. No direct adverse events related to the concentrate itself were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of recent large-scale clinical trials directly assessing the concentrate's efficacy. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrate?
The clinical indications are detailed in the FDA documentation, primarily for use in dialysis treatments to manage electrolyte balance.
What outcomes have been reported in clinical studies?
Studies report successful emergency dialysate production and methods for dextrose determination in dialysis solutions.
What complications have been reported?
Reported complications include potential supply chain issues affecting availability, with no direct adverse events noted in the studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.