K132429 is an FDA 510(k) clearance for the SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA .... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).
Submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 123 days - within the typical 510(k) review window.
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 Terumobct, Inc. devices
NCT01736657
Completed
Interventional
Industry-sponsored
Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.
| Condition studied |
Sickle Cell Disease |
| Study design |
Single group |
| Eligibility |
All sexes
· 12 Years+
|
| Principal investigator |
Keith Quirolo, MD |
| Sponsor |
Terumo BCT
(industry)
|
Started 2012-11-01
→
Primary completion 2013-06-01
Primary outcome
Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)
Secondary outcome
Procedural Success of the Spectra Optia System in the Evaluable Population
View full study on ClinicalTrials.gov