METADATA last updated: 2026-03-05 by BA file_name: 2021-05-18_Pre-EUA Sub - FloodLAMP Pooled Swab Collection Kit DTC.md file_date: 2021-05-18 title: Pre-EUA Sub - FloodLAMP Pooled Swab Collection Kit DTC category: regulatory subcategory: fl-fda-submissions tags: collection source_file_type: sketch xfile_type: NA gfile_url: NA xfile_github_download_url: NA pdf_gdrive_url: https://drive.google.com/file/d/13ghhBwFK9nAfA2htGq7mQ_5_JXSgTixt pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/fl-fda-submissions/2021-05-18_Pre-EUA%20Sub%20-%20FloodLAMP%20Pooled%20Swab%20Collection%20Kit%20DTC.pdf conversion_input_file_type: pdf conversion: megaparse-u license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 1515 words: 1093 notes: summary_short: The FloodLAMP Pooled Swab Collection Kit DTC instructions describe how up to four people can self-collect anterior nasal swabs into a single barcoded/QR-coded tube, with step-by-step workflows for both a mobile app–guided and non-app version. It explains kit contents, hygiene and swabbing steps, participant association and tube scanning in the app, and how to package and return specimens via collection point or prepaid mailer. It includes EUA-required limitations stating the product is authorized only for home collection/maintenance of anterior nasal swabs for SARS-CoV-2 nucleic acid detection during the active emergency declaration. CONTENT ***INTERNAL TITLE:*** FloodLAMP Pooled Swab Collection Kit DTC **FloodLAMP Biotechnologies** A Public Benefit Corporation FloodLAMP Pooled Swab Collection Kit DTC For IVD Use. For use under emergency use authorization only. ## Mobile App Version For use with the FloodLAMP Mobile App ### Your kit includes: _Diagram of swabs_ Swabs _Diagram of QR coded tube_ QR coded tube _Diagram of Biohazard bag_ Biohazard bag _Diagram of Fact sheet_ Fact sheet _Diagram of Return shipping mailer_ Return shipping mailer (optional) ### Getting started - Ensure you and everyone contributing samples washes their hands! - Inspect contents of kit and ensure you have enough swabs and tubes for the collection. - Follow the instructions inside this sheet ### Returning your kit - Contact your program coordinator for kit return details 1. Get the app Download the FloodLAMP app and register for an account, then login to the app. First time users will need to sign the FloodLAMP consent form. You can associate minors with your account profile. 2. Begin collection Tap the “Collect” button from the app home screen. Follow the swabbing instructions, which are listed here in steps 3-8. 3. Sanitize Wash your hands thoroughly for 20 seconds and dry them completely before collecting your sample. 4. Open the kit Open your kit and distribute swabs to each participant who will be adding samples to the tube. 5. Open swab packs Each participant should open their swab pack. Be careful not to touch the absorbent end with your hands. 6. Swab the first nostril Each participant should insert the swab tip into their first nostril until the absorbent end is no longer visible. Swab the sides of the nostril in a circular motion 4 times. Make sure to twist the swab as you go. 7. Swab the other nostril Each participant should repeat the previous steps with the same swab in the second nostril. 8. Put swabs in tube Each participant should place their swab in the barcoded tube and snap off the end of the swab at the break point. 9. Cap tube Once each participant has added their swab, securely tighten the cap onto the tube. 10. Scan and add participants Complete the Collect work flow in the app. You can add up to 4 swabs in each tube, and associate the partipants using their FloodLAMP registered email addresses. Minors will be registered under their guardian’s account. 11. Put the tube in the biohazard bag Securely close the zippered bag, then thoroughly wash or sanitize your hands. 12. Return the biohazard bag By collection point: If your kit does not include a return mailer, bring your biohazard bag to the collection point designated by your program administrator. By mail: If your kit includes a return mailer, seal the biohazard bag in the return mailer. This packaging is specially designed for carrying samples suspected of carrying infectious substances. Do NOT replace it. Note: Your return shipping has already been paid. ### Need help? Contact support@floodlamp.bio or select “Support” from the FloodLAMP app menu. FloodLAMP.bio This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA; This product has been authorized only for the home collection and maintenance of anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. ## Non-Mobile App Version ### Your kit includes: _Diagram of swabs_ Swabs _Diagram of QR coded tube_ QR coded tube _Diagram of Biohazard bag_ Biohazard bag _Diagram of Fact sheet_ Fact sheet _Diagram of Return shipping mailer_ Return shipping mailer (optional) ### Getting started - Ensure you and everyone contributing samples washes their hands! - Inspect contents of kit and ensure you have enough swabs and tubes for the collection. - Follow the instructions inside this sheet ### Returning your kit - Contact your program coordinator for kit return details 1. Sanitize Wash your hands thoroughly for 20 seconds and dry them completely before collecting your sample. 2. Open the kit Open your kit and distribute swabs to each participant who will be adding samples to the tube. 3. Open swab packs Each participant should open their swab pack. Be careful not to touch the absorbent end with your hands. 4. Swab the first nostril Each participant should insert the swab tip into their first nostril until the absorbent end is no longer visible. Swab the sides of the nostril in a circular motion 4 times. Make sure to twist the swab as you go. 5. Swab the other nostril Each participant should repeat the previous steps with the same swab in the second nostril. 6. Put swabs in tube Each participant should place their swab in the barcoded tube and snap off the end of the swab at the lower break point. You can add up to 4 swabs in each tube. 7. Cap tube Once each participant has added their swab, securely tighten the cap onto the tube. 8. Put the tube in the biohazard bag Securely close the zippered bag, then thoroughly wash or sanitize your hands. 9. Return the biohazard bag By collection point: If your kit does not include a return mailer, bring your biohazard bag to the collection point designated by your program administrator. By mail: If your kit includes a return mailer, seal the biohazard bag in the return mailer. This packaging is specially designed for carrying samples suspected of carrying infectious substances. Do NOT replace it. Note: Your return shipping has already been paid. ### Need help? Contact support@floodlamp.bio or select “Support” from the FloodLAMP app menu. FloodLAMP.bio This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA; This product has been authorized only for the home collection and maintenance of anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.