Cleared Traditional

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615) - FDA 510(k) Clearance

K180615 · Fresenius Kabi USA,Llc · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
271d
Days
-
Risk

K180615 is an FDA 510(k) clearance for the AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer S.... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius Kabi USA,Llc (Lake Zurich, US). The FDA issued a Cleared decision on December 4, 2018 after a review of 271 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Fresenius Kabi USA,Llc devices

Submission Details

510(k) Number K180615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2018
Decision Date December 04, 2018
Days to Decision 271 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
141d slower than avg
Panel avg: 130d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT02372877 Completed Interventional Industry-sponsored

Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients

83
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Sickle Cell Anemia
Study design Single group
Eligibility All sexes · 6 Years+
Principal investigator Paul Swerdlow, MD
Sponsor Fenwal, Inc. (industry)
Started 2015-05-01 → Primary completion 2017-12-07 → Completed 2018-01-19
Primary outcome
Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).
Secondary outcome
Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.
View full study on ClinicalTrials.gov