Device Information

The EGENS Pregnancy Test Midstream devices are qualitative immunochromatographic assays designed for early pregnancy detection. They consist of a nitrocellulose test strip housed in plastic, usable in either dip or midstream mode. Both tests detect hCG in urine, indicating pregnancy as early as five days before the expected menstrual period. Midstream I displays a single red line for positive results, while Midstream II shows a plus sign (+).

Indications 

The devices are intended to detect hCG in urine, aiding early pregnancy detection qualitatively. This can occur as early as five days before the expected period, with the result visible within 3 to 10 minutes.

Intended Use 

The EGENS Pregnancy Test Midstream devices are intended for home use. They detect pregnancy through hCG levels in urine. Any adult can use the devices, and no special training or equipment is required.

Availability

• Type: Over-the-counter

Study Results

• Clinical Testing: Both devices demonstrated 100% accuracy in detecting hCG in early pregnancy, with lay user results matching professional evaluations.
• Nonclinical and Safety Testing: Precision tests showed consistent results across different hCG concentrations, with no observed hook effect at concentrations up to 500,000 mIU/mL. Cross-reactivity and interference tests confirmed that various substances and urine conditions do not affect device performance.

Regulatory Information

• Regulation Number: 21 CFR 862.1155
• Regulatory Class: II
• Product Code: LCX
• 510(k) Number: K232864 The devices must comply with regulations for hCG detection systems and follow labeling and quality system requirements.

Manufacturer Information

• Name: Nantong Egens Biotechnology Co., Ltd.
• Address: Building 15, 1692 Xinghu Avenue, Nantong Economy and Technology Development Zone, Jiangsu, China.
• Contact Person: Joe Shia

Predicate Device Information

• Predicate Devices: Wondfo One Step HCG Urine Pregnancy Test Strip (K150022)
• Differences: EGENS offers faster results (3 minutes vs. 5 minutes) and solely targets over-the-counter use.
• Comparison: Both devices detect hCG using similar technology, with no significant differences in sensitivity or accuracy.

Implications 

These devices provide an accessible, early pregnancy detection option. They are easy to use and reliable for home testing.

References

1. EGENS Pregnancy Test Midstream I, Midstream II. K232864. FDA summary link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232864
2. http://www.egensbio.com