Name of Device for 510 (k) Submission: Positively Pregnant: A Digital Pregnancy Test
Description of Predicate: Clearblue Early Digital Pregnancy Test, 510 (k) K200913 (U.S. Food & Drug Administration, 2021). https://www.accessdata.fda.
Description of the Proposed Change (Enhancement/Modification):
Material Change in the handle/ user friendliness of how the device is used. Change to the mode of detection for the variants of hCG.
Based on the predicate device and the information above please write the following sections of a 510(k) application.
Section 4: Indications for Use Statement
Section 11: Device Description
Section 18: Performance Testing – Bench
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