EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Device Description

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the EGENS Pregnancy Test Midstream I and II, based on the provided text:

EGENS Pregnancy Test Midstream I and II: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it demonstrates the device's analytical and clinical performance through various studies. The key performance characteristics are compared against the predicate device and established expectations for pregnancy tests.

Performance Characteristic	Acceptance Criteria (Implied/Expected)	Reported Device Performance (EGENS Pregnancy Test Midstream I & II)
Analytical Sensitivity	10 mIU/mL (matches predicate)	Both devices demonstrated a sensitivity of 10 mIU/mL (100% positive detection at 10 mIU/mL, with decreasing positive rates at lower concentrations).
Hook Effect	No hook effect up to high hCG concentrations.	No hook effect observed at hCG concentrations up to 500,000 mIU/mL.
Specificity (Non-pregnant females)	No false positive results.	No false positive results were observed in 300 urine samples from healthy, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups.
Cross-Reactivity	No cross-reactivity with hLH, hFSH, hTSH.	No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, and 1000 µIU/mL hTSH at tested concentrations. Performance not affected by hCG ß-core fragment up to 500,000 pmol/L.
Interfering Substances	No interference from common substances and physiological variations (pH, density).	No interference observed from a wide range of common substances (Acetaminophen, Aspirin, Ascorbic acid, Caffeine, Hemoglobin, etc.) at specified concentrations. Performance not affected by urine pH between 4 and 9 or urine density between 1.000 and 1.035.
Method Comparison (Conformity with Predicate)	High conformity (e.g., 100% agreement) with the predicate device.	100% conformity between the candidate device and the predicate device in a study of 206 "real" urine samples and an additional 100 urine samples tested by both devices.
Lay Person Study Agreement with Professional Results	High agreement with professional results.	100% positive and 100% negative conformity with professional results from 206 individual pregnancy tests. High percent agreement (98-100%) was also shown for spiked urine samples (5mIU/ml, 6.5mIU/ml, 8.0mIU/ml, 10mIU/ml hCG) when tested by lay users.
Early Pregnancy Detection	Early detection of pregnancy, e.g., five days before expected period, consistently.	Detected 68% positive hCG five days before the Expected Menstrual Period (EMP) (69% in the summary table), and 100% positive hCG on the day of EMP. This generally aligns with "some cases as early as five (5) days before the expected period".
Ease of Use (Lay Person)	Consumers find the test easy to use and understand labeling.	Questionnaire results reflected that consumers found the test easy to use and did not have trouble understanding the labeling and interpreting the results.
Reproducibility	Consistent results across lots and operators.	Both devices exhibited reproducible results across three device lots and three different operators for analytical sensitivity testing.

2. Sample Size Used for the Test Set and Data Provenance

Analytical Performance (Precision/Sensitivity):
- Sample Size: For each hCG concentration (0, 2.5, 5, 6.5, 8, 9, 10, 15, 25, 50 mIU/mL), 5 replicates were tested per day for 5 days for each of 3 device lots. This totals 5 (replicates) * 5 (days) * 3 (lots) = 75 tests per hCG concentration. With 10 concentrations, this is 750 tests per device type (Midstream I or II). The combined data for both dip and midstream methods suggests 150 total results per concentration from the 3 lots (50 per lot).
- Data Provenance: Negative female urine spiked with WHO-traceable hCG standard. This is laboratory-controlled, prospective data. The country of origin of the urine samples is not explicitly stated but presumably from the manufacturer's location or a related lab.
Hook Effect Test:
- Sample Size: Not explicitly stated, but negative urine samples were spiked with 7 varying hCG concentrations. "All tested concentrations gave a positive result." This implies each concentration was tested at least once, and likely in replicates to confirm.
- Data Provenance: Laboratory-controlled, prospective data using spiked negative urine samples.
Specificity and Cross-Reactivity:
- Specificity (Non-pregnant females): 300 urine samples.
- Cross-Reactivity (hLH, hFSH, hTSH, hCG ß-core fragment): 30 replicates per test (negative and positive urine samples spiked with cross-reactants) using three device lots. This means 30 * 3 = 90 tests per cross-reactant condition.
- Data Provenance: Prospective collection of urine samples and laboratory-controlled spiking for cross-reactivity. The "300 urine samples" for specificity were "collected from healthy, nonpregnant female in pre-menopausal (ages 18~~40 years old), peri-menopausal (41~~55 years old) and post-menopausal (>55 years old) groups. 100 people for each age group."
Interfering Substance Study:
- Sample Size: Urine samples containing 0, 5, and 10 mIU/mL hCG were spiked with "the interfering substance to obtain the certain desired test concentration." The number of replicates is not specified for each substance, but implies testing was sufficient to determine no effect.
- Data Provenance: Laboratory-controlled, prospective data using spiked urine samples.
Method Comparison Study (with Predicate Device):
- Sample Size:
  - 206 urine samples initially: 100 for Midstream I, 106 for Midstream II.
  - Additional 100 urine samples tested by both Midstream I and Midstream II, and both in-stream and dip methods, yielding 200 results for each device.
  - Total urine samples used for method comparison involving "real" samples: 206 + 100 = 306 unique samples.
- Data Provenance: Prospective collection of urine samples from women presenting to test for pregnancy. This represents clinical, prospective data.
Lay Person Study:
- Sample Size (Clinical Samples): 306 women's individual urine samples. 200 for Midstream I, 106 for Midstream II.
- Sample Size (Spiked Samples): 400 spiked urine samples (100 samples each for 5, 6.5, 8, 10 mIU/mL hCG) were tested by 200 lay persons.
- Data Provenance: Prospective collection of urine samples and clinical prospective testing by lay users, with concurrent professional testing as ground truth. (Spiked samples were laboratory-controlled, prospective).
Early Pregnancy Test Study:
- Sample Size: 585 urine samples collected from 65 pregnant women (65 characterized cycle segments of conceptive cycles).
- Data Provenance: Prospective collection of samples from pregnant women. This is clinical, prospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

General Ground Truth for Clinical Samples: For the "professional testing" mentioned in the Lay Person Study and the "Method Comparison Study," the ground truth was presumably established by a laboratory assay (e.g., quantitative hCG measurement) or by the predicate device's results. The document refers to "professional results" and "predicate device" as the comparators.
Qualifications of Experts: The document does not specify the number or qualifications of "experts" (e.g., laboratory technicians, clinical professionals) who interpreted the ground truth results for clinical studies. For the "professional testing" in the lay person study, it's implied clinical laboratory personnel.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1. For quantitative results (like hCG levels used for spiking or professional ground truth), there wouldn't typically be adjudication in the same way as for human interpretation of images. For the method comparison and lay person studies, the "professional result" or "predicate device" served as the established outcome against which the new device was compared. Discrepancies, if any, would likely be analyzed, but a formal adjudication process (i.e., multiple readers resolving disagreements) is not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC Comparative Effectiveness Study: This is not an AI-assisted device, but rather a lateral flow immunoassay (pregnancy test). Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The "readers" are the lay users or professionals interpreting the test result line.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Algorithm Only Not Applicable: This is a diagnostic test where the user interprets a visual result (line appearing). There is no "algorithm" in the sense of a software-based diagnostic tool that operates without human intervention. The device's performance is inherently "standalone" in that it provides a result without additional computational input, but it still requires human visual interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Analytical Studies (Sensitivity, Hook Effect, Cross-Reactivity, Interfering Substances): Ground truth was established by spiking known concentrations of hCG or interfering substances into negative urine samples, traceable to WHO International Standard.
Specificity Study (Non-pregnant females): Ground truth was established by clinical assessment (healthy, non-pregnant status of donors) and presumably confirmation of negative hCG status by a laboratory method.
Method Comparison Study: Ground truth was the result of the legally marketed predicate device (Wondfo One Step HCG Urine Pregnancy Test Strip, Cassette, Midstream).
Lay Person Study: Ground truth was professional testing results (presumably a laboratory hCG assay or the predicate device).
Early Pregnancy Test Study: Ground truth was based on characterized cycle segments of conceptive cycles from pregnant women, meaning the women were confirmed pregnant and samples were collected relative to their Expected Menstrual Period (EMP). This is a form of clinical outcomes data coupled with the expected physiological presence of hCG.

8. The Sample Size for the Training Set

No Explicit Training Set: Lateral flow immunoassays like this device typically do not have a "training set" in the machine learning sense. The device's performance is based on its chemical and biological components (antibodies, membrane, etc.) which are developed and optimized through R&D. The studies described are for validation and characterization of the finished device's performance, not "training."

9. How the Ground Truth for the Training Set was Established

As there is no explicit "training set" in the context of machine learning for this device, this question is not applicable. The device's operational characteristics (e.g., antibody binding, flow dynamics) are established through a traditional scientific and engineering development process, not a data-driven training regimen.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 26, 2024

Nantong Egens Biotechnology Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K232864

Trade/Device Name: EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: December 26, 2023 Received: December 27, 2023

Dear Joe Shia:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232864

Device Name EGENS Pregnancy Test Midstream I EGENS Pregnancy Test Midstream II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K232864

1.	Date:	January 22, 2024
2.	Submitter:	Nantong Egens Biotechnology Co., Ltd.Building 15, 1692 Xinghu AvenueNantong Economy and Technology Development ZoneNantong, Jiangsu 226010China
3.	Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com
4.	Device Name:	EGENS Pregnancy Test Midstream IEGENS Pregnancy Test Midstream II
	Classification:Product Code:CFR:	Class IILCX862.1155
5.	Predicate Devices:	K150022Wondfo One Step HCG Urine Pregnancy Test StripWondfo One Step HCG Urine Pregnancy Test CassetteWondfo One Step HCG Urine Pregnancy Test Midstream

6. Intended Use

Device Description 7.

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II

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are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.

Similarities
Item	Candidate device	Predicate device
Intended use	A rapid chromatographicimmunoassay for thequalitative detection ofhuman chorionicgonadotropin (hCG) inurine, as an aid in earlydetection of pregnancy, insome cases as early as five(5) days before theexpected period, i.e., asearly as six (6) days beforethe day of the missedperiod.	Same
Specimen	Urine	Urine
Assay technical	Immunochromatographicassay	Immunochromatographicassay
Sensitivity	10 mIU/mL	10 mIU/mL
Results	Qualitative	Qualitative
Target user	Over the counter use	Over the counter use
Format	Midstream	Strip, cassette, midstream
Differences
Item	Device	Predicate
Time to result	3-10 minutes	5 minutes

Substantial Equivalence Information 8.

9. Test Principle

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the pre-coated (Goat anti HCG polyclonal antibody) membrane. During the test procedures, hCG in the urine specimen reacts with the dye conjugate and forms a complex migrates along

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the membrane to the hCG antibody line (T), and remains captured in the T line. As a result a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The Control line should develop in the control zone regardless of the test result. If no lines appear, or if only a red band appears in the test zone, indicating the test result is invalid.

10. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility/Sensitivity

Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 2.5, 5, 6.5, 8, 9, 10, 15, 25 and 50 mIU/mL. Each sample was tested by both dip and midstream methods in 5 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration. The results summarized in the tables below are combined data for both dip and midstream testing.

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
2.5	50	0	50	0	50	0	150	0	100%	0%
5	50	0	50	0	50	0	150	0	100%	0%
6.5	47	3	46	4	47	3	140	10	93%	7%
8	25	25	22	28	27	23	74	76	49%	51%
9	7	43	5	45	4	46	16	134	11%	89%
10	0	50	0	50	0	50	0	150	0%	100%
15	0	50	0	50	0	50	0	150	0%	100%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%

EGENS Pregnancy Test Midstream I

EGENS Pregnancy Test Midstream II

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
2.5	50	0	50	0	50	0	150	0	100%	0%
5	50	0	50	0	50	0	150	0	100%	0%
6.5	48	2	47	3	46	4	141	9	94%	6%
8	27	23	24	26	24	26	75	75	50%	50%

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9	45	47	43	135	10%	90%
10	50	50	50	150	0%	100%
15	50	50	50	150	0%	100%
25	50	50	50	150	0%	100%
50	50	50	50	150	0%	100%

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II exhibited reproducible results.

Based on the above results, the sensitivity of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are both demonstrated to be 10mIU/mL.

b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.

c. Hook effect test:

Negative urine samples were spiked with varying hCG concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.

d. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.

Stability:

Products in sealed foil pouch are stable for 24 months at 2℃ and 30℃, based on the real time stability study.

e. Specificity and cross reactivity

To evaluate specificity, 300 urine samples were collected from healthy, nonpregnant female in pre-menopausal (ages 18~~40 years old), peri-menopausal (41~~55 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and midstream testing are evaluated. No false positive results were observed for any of the age groups.

To evaluate cross-reactivity, negative and positive urine samples (0, 5 and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). These samples were tested in 30 replicates using three device lots. No cross-reactivity was observed at tested concentration. To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and

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5 mIU/mL hCG) and positive urine samples (10 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. These samples were tested in 30 replicates using three device lots. The device performance is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.

f. Interfering substance

To evaluate potential interferers with EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:

Substance	Concentration
Acetaminophen	20 mg/dL
Acetylsalicylic	20 mg/dL
Ascorbic acid	20 mg/dL
Atropine	20 mg/dL
Caffeine	20 mg/dL
Gentisic acid	20 mg/dL
Glucose	2 g/dL
Hemoglobin	20 mg/dL
Tetracycline	20 mg/dL
Ampicillin	20 mg/dL
Albumin	20 mg/dL
β-hydroxybutyrate	2000 mg/dL
Ephedrine	20 mg/dL
Phenylpropanolamine	20 mg/dL
Phenothiazine	20 mg/dL
EDTA	80 mg/dL
Salicyclic Acid	20 mg/dL
Benzoylecgonine	10 mg/dL
Cannabinol	10 mg/dL
Codeine	6ug/dL
Ethanol	1.0%
Bilirubin	2mg/dL
Pregnanediol	1500µg/dL
Thiophene	20 mg/dL
Ketone	20 mg/dL

To evaluate the effect of urine pH on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of EGENS Pregnancy Test Midstream I and EGENS Pregnancy

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Test Midstream II.

To evaluate the effect of urine density on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that urine with a relative density of 1.000 to 1.035 does not affect the performance of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II.

B. Method comparison study

Method comparison with predicate device

The performance of the new device was compared to the predicate test. A total of 206 urine samples were first collected from 206 women presenting to test for pregnancy. Of the total 206 samples, 100 samples were tested by EGENS Pregnancy Test Midstream I device and the remaining 106 samples were tested by EGENS Pregnancy Test Midstream II device. Another 100 urine samples were collected from an additional 100 women presenting to test for pregnancy. These additional 100 urine samples were tested by both EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II devices using both the in-stream method and dip method, yielding 200 testing results for each device from the additional 100 urine samples. Test results showed 100% conformity between the candidate device and the predicate device.

EGENS Pregnancy TestMidstream I (Dip)		Predicate device
		Positive	Negative	Total
Candidate device	Positive	74	0	74
	Negative	0	75	75
	Total	74	75	149

Summary EGENS Pregnancy Test Midstream I Testing Results

EGENS Pregnancy TestMidstream I (In-stream)		Predicate device
		Positive	Negative	Total
Candidate device	Positive	77	0	77
	Negative	0	74	74
	Total	77	74	151

Summary EGENS Pregnancy Test Midstream II Testing Results

EGENS Pregnancy TestMidstream II (Dip)		Predicate device
		Positive	Negative	Total
Candidate device	Positive	78	0	78
	Negative	0	75	75
	Total	78	75	153

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EGENS Pregnancy TestMidstream II (In-stream)		Positive	Negative	Total
Candidate device	Positive	76	0	76
	Negative	0	77	77
	Total	76	77	153

C. Lay person study

306 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.

Summary

EGENS Pregnancy TestMidstream I(in-stream or dip method)		Professional Result		Total
		Positive	Negative
Lay user Result	Positive	101	0	101
	Negative	0	99	99
Total		101	99	200

EGENS Pregnancy TestMidstream II(in-stream or dip method)		Professional Result		Total
		Positive	Negative
Lay user Result	Positive	54	0	54
	Negative	0	52	52
Total		54	52	106

From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.

Spiked urine samples were also tested by lay person. Urine samples were prepared at 5mIU/ml, 6.5mIU/ml, 8.0mIU/ml and 10mIU/ml hCG concentrations by spiking hCG into negative pooled urine specimens. Each sample was aliquoted into individual containers and blind-labeled. These samples were tested by 200 lay persons using either EGENS Pregnancy Test Midstream I or EGENS Pregnancy Test Midstream II devices.

For EGENS Pregnancy Test Midstream I

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Numberof samples	hCGconcentration(mIU/mL)	Lay user result		Professional Result		PercentAgreement
		Numberof positive	Numberof negative	Numberof positive	Number ofnegative
100	5	0	100	0	100	100%
100	6.5	5	95	7	93	98%
100	8	49	51	51	49	98%
100	10	100	0	100	0	100%

For EGENS Pregnancy Test Midstream II

Numberof samples	hCGconcentration(mIU/mL)	Lay user result		Professional Result		PercentAgreement
100	5	0	100	0	100	100%
100	6.5	6	94	7	93	99%
100	8	50	50	52	48	98%
100	10	100	0	100	0	100%

Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.

D. Early Pregnancy Test Study

In this study, total 585 urine samples from 65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women. All samples were masked and randomized. Each sample was tested by two formats of the device. The new device detected 68% positive hCG five days before the

Expected Menstrual Period (EMP), and 100% positive hCG on the day of EMP. No differences were observed between different device formats. The following table is the summary of the data.

Day relative to EMP	EMP-8	EMP-7	EMP-6	EMP-5	EMP-4	EMP-3	EMP-2	EMP-1	EMP
# of cycles positive for hCG	3/65	9/65	25/65	45/65	59/65	63/65	64/65	65/65	65/65
% cycles positive for hCG	5%	14%	38%	69%	91%	97%	98%	100%	100%

11. Conclusion

Based on the test principle and performance characteristics of the device

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including precision, cut-off, interference, specificity, method comparison and lay-user studies of the device, it's concluded that EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.