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Surearly SMART Ovulation Test

Sugentech Inc._Osong Branch · Model Surearly SMART Ovulation Test · UDI-DI 08809408863482

NGE

510(k) clearances

Adverse events

Recalls

107

Facilities

Description

The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the test stick. It detects LH (10 mIU/mL or greater) and Progesterone metabolites (5 ug/mL or greater) in urine. Monoclonal LH antibodies and P3G-BSA conjugate with anti-P3G antibodies are immobilized on test lines 1 and 2 respectively. The test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, LH and P3G combine with antibody gold conjugates on the gold conjugate pad. The antigen-antibody complexes react with anti-LH antibody on test line 1 and P3G-BSA on test line 2, forming red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, Surearly SMART Ovulation Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graph and additional messages to help your comprehensive management of hormone cycle.

Recalls

Date	Firm	Reason
2025-11-22	Changchun Wancheng Bio-Electron Co., Ltd.	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2008-11-07	Quest Products Inc.	The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.