Enzyme Packed Cartridge - RELiZORB
by Alcresta Therapeutics, Inc.
510(k) K231156
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231156 | Date30 Aug 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- PLQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5985
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Enzyme Packed Cartridge - RELiZORB is a disposable medical device classified as an enzyme cartridge (Product Code: PLQ) designed to deliver immobilized lipase for enzymatic digestion. It is intended for use in enteral feeding systems to aid in the breakdown of dietary fats, improving nutrient absorption in patients with fat malabsorption, such as those with exocrine pancreatic insufficiency. The device incorporates a proprietary microbead technology to immobilize the enzyme, ensuring sustained activity and targeted fat hydrolysis.
RELiZORB is supplied as a single-use, non-sterile cartridge and is intended for use in hospital or home enteral feeding environments. It requires no additional sterilization and is compatible with standard enteral administration setups. The device is regulated under FDA 510(k) clearance (K231156) and falls under Class II medical devices, adhering to regulatory standards for enzyme-based therapies in gastroenterology and urology. Storage conditions are not specified but should follow standard medical device protocols to maintain enzyme efficacy.
From the manufacturer
Improved nutrition from the outside in. The only FDA-cleared enzymatic product studied and indicated for use with enteral feeding, RELiZORB is a cartridge that utilizes Alcresta's proprietary enzyme immobilization technology and contains iLipase ®, the digestive enzyme lipase attached to polymeric microbead carriers.
Alcresta develops rare disease, enzyme-based products helping to address fat malabsorption (often due to exocrine pancreatic insufficiency) in patients who are enterally fed at home or in the hospital.
Manufacturer's product page: B4105 HCPCS billing code
Other devices from Alcresta Therapeutics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Enzyme Packed Cartridge - RELiZORB used for?
The RELiZORB cartridge is designed to deliver immobilized lipase enzyme through enteral feeding systems. It helps break down dietary fats, improving nutrient absorption in patients who struggle with fat malabsorption, such as those with exocrine pancreatic insufficiency. The device’s microbead technology ensures sustained enzyme activity for targeted fat hydrolysis.
Is the RELiZORB cartridge sterile and reusable?
The RELiZORB cartridge is supplied as a single-use, non-sterile device. It does not require additional sterilization and is intended for one-time use in either hospital or home enteral feeding environments. This design ensures safety and efficacy without the need for reprocessing.
How does the microbead technology in RELiZORB improve enzyme performance?
The proprietary microbead technology in RELiZORB immobilizes the lipase enzyme, which allows for sustained and targeted activity during fat digestion. This method enhances enzyme stability and ensures consistent performance over time, improving nutrient absorption for patients with fat malabsorption.
What storage conditions should be followed for the RELiZORB cartridge?
While specific storage conditions are not detailed in the product information, it is recommended to follow standard medical device protocols to preserve enzyme efficacy. This typically includes storing the cartridge in a cool, dry place, away from direct sunlight or extreme temperatures, until use.
Can the RELiZORB cartridge be used with any enteral feeding system?
The RELiZORB cartridge is designed to be compatible with standard enteral administration setups. However, compatibility should be confirmed with the specific feeding system in use to ensure proper integration and functionality. Always refer to the manufacturer’s instructions for detailed guidance.