Cleared Traditional

K163057 - Relizorb

K163057 is an FDA 510(k) clearance for Relizorb, manufactured by Alcresta Therapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PLQ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K163057 · Alcresta Therapeutics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
253d
Days
Class 2
Risk

K163057 is an FDA 510(k) clearance for the Relizorb. Classified as Enzyme Packed Cartridge (product code PLQ), Class II - Special Controls.

Submitted by Alcresta Therapeutics, Inc. (Newton, US). The FDA issued a Cleared decision on July 12, 2017 after a review of 253 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5985 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcresta Therapeutics, Inc. devices

FDA 510(k) Submission Details - K163057

510(k) Number K163057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date July 12, 2017
Days to Decision 253 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 131d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

PLQ Device Classification - Class 2, Special Controls

Product Code PLQ Enzyme Packed Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5985
Definition Hydrolyze Fats In Enteral Formula.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02598128 Completed Interventional Industry-sponsored

Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding In-line Digestive Enzyme Cartridge (RELIZORB) in Patients With Cystic Fibrosis Receiving Enteral Feeding

34
Patients (actual)
11
Sites
Treatment
Purpose
Triple
Masking
Condition studied Exocrine Pancreatic Insufficiency
Study design Crossover
Eligibility All sexes · 4 Years+
Principal investigator Russell G. Clayton, Sr., DO
Sponsor Alcresta Therapeutics, Inc. (industry)
Started 2015-11-01 → Primary completion 2016-06-01
Primary outcome
Number of Patients With Adverse Events and Unanticipated Adverse Device Effects
View full study on ClinicalTrials.gov