Clue

GUDID 04260749840008

Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.

BioWink GmbH

Self-care monitoring/reporting software

• Primary Device ID: 04260749840008
• NIH Device Record Key: 85c5884e-1251-4f85-b380-756222501bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clue
• Version Model Number: 1
• Company DUNS: 342751189
• Company Name: BioWink GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260749840008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193330

FDA Product Code

• PYT: Device, Fertility Diagnostic, Contraceptive, Software Application

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-18
• Device Publish Date: 2022-04-08

Devices Manufactured by BioWink GmbH

• 04260749840039 - Clue App: 2023-08-04 Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. T
• 04260749840046 - Clue App: 2023-08-04 Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. T
• 04260749840022 - Clue Conceive: 2023-05-22 Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the
• 04260749840015 - Clue Conceive: 2023-05-22 Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the
• 04260749840008 - Clue: 2022-04-18Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
• 04260749840008 - Clue: 2022-04-18 Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses