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Dry Ac Acid Concentrate Mix for Bicarbonate Hemodialysis
Gambro Renal Products
Summary: The dry acid concentrate mix by Gambro Renal Products is used in bicarbonate hemodialysis. It is FDA 510k cleared and linked to 5 studies, though none directly related to the device.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K011368 ↗
Decision Date ?
August 2, 2001
Product Code ?
KPO
Device Class ?
Class 2
Evidence ?
0 studies
The dry acid concentrate mix for bicarbonate hemodialysis was cleared by the FDA via the 510k pathway on August 2, 2001. It is manufactured by Gambro Renal Products and classified as a Class 2 device.
What It Is
The dry acid concentrate mix is a component used in bicarbonate hemodialysis to help maintain the acid-base balance in patients undergoing dialysis. It is designed for use in dialysis machines to facilitate the removal of waste products from the blood.
FDA-Cleared Indications
- For use as a dry acid concentrate component in bicarbonate hemodialysis.
- For preparation of dialysate when used with compatible hemodialysis equipment and bicarbonate concentrate.
Clinical Applications
- Preparing dialysate for maintenance hemodialysis.
- Use during in-center hemodialysis treatments for patients with advanced or end-stage kidney disease.
- Use with compatible bicarbonate hemodialysis machines according to the device labeling and dialysis-unit procedures.
Evidence Summary
The available literature includes 5 studies, though none directly pertain to the dry acid concentrate mix. The studies range from 2013 to 2025 and cover various unrelated topics.
Reported Outcomes
Published studies report no direct outcomes related to the dry acid concentrate mix for bicarbonate hemodialysis. The linked studies focus on unrelated topics such as livestock nutrition and dairy cow milk synthesis.
Safety Profile
Reported complications include no specific safety data related to the dry acid concentrate mix. The studies provided do not address safety concerns for this device.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of the dry acid concentrate mix. Further research is needed to evaluate its specific clinical outcomes and potential complications.
Practical Considerations
- It is a dialysis-system consumable, not an implantable device or medication administered directly to the patient.
- Compatibility with the specific hemodialysis machine, bicarbonate concentrate, water system, and mixing or proportioning equipment must be confirmed before use.
- The concentrate must be stored, mixed, labeled, and handled according to the manufacturer’s instructions and dialysis-facility protocols.
- Incorrect concentration, contamination, expired product, or improper mixing can produce unsafe dialysate and may cause serious electrolyte or acid-base complications.
- MRI considerations do not generally apply because the product is not implanted and is not used in the MRI environment; dialysis equipment should be kept out of the scanner room unless specifically cleared.
Frequently Asked Questions
What are the clinical indications for dry acid concentrate mix?
The dry acid concentrate mix is indicated for use in bicarbonate hemodialysis to maintain acid-base balance in patients undergoing dialysis.
What outcomes have been reported in clinical studies?
No specific outcomes related to the dry acid concentrate mix have been reported in the provided studies.
What complications have been reported?
No complications specific to the dry acid concentrate mix have been reported in the provided evidence.
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.