Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
FDA 510(k) K242706 · Fujirebio Diagnostics,Inc.
510(k) numberK242706
Submission
- Device name
- Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- September 9, 2024
- Decision date
- May 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SET – Immunoassay Blood Test For Amyloid Pathology Assessment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5840
- Specialty
- Immunology
An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimers Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information.
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Questions and answers
When was Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio cleared by the FDA?
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) received a 510(k) decision of Substantially Equivalent on May 16, 2025, 249 days after the submission was received.
What is the product code of K242706?
The FDA product code is SET – Immunoassay Blood Test For Amyloid Pathology Assessment, a Class II (moderate risk) device regulated under 21 CFR 866.5840.