ACESO Early Pregnancy Test

K234152 · Aceso Laboratories, Inc. · LCX · Apr 5, 2024 · Clinical Chemistry

Device Facts

• Record ID: K234152
• Device Name: ACESO Early Pregnancy Test
• Applicant: Aceso Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

ACESO Early Pregnancy Test 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. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only.

Device Story

Lateral flow immunoassay for qualitative hCG detection in urine; utilizes mouse anti-beta hCG monoclonal antibody-dye conjugate and goat anti-hCG polyclonal antibody-coated membrane. Sample applied via dip or instream mode; capillary action moves sample across membrane. hCG-antibody-dye complex captured at test line (T) produces red band; control line (C) confirms test validity. Used by lay users in home setting. Visual readout within 3-10 minutes. Positive result indicates pregnancy; negative result indicates no pregnancy or hCG below 10 mIU/mL cutoff. Results aid early pregnancy detection; users advised to confirm positive results with healthcare provider.

Clinical Evidence

Clinical evidence includes a lay-person study (n=100) showing 100% positive/negative conformity with professional results. An early pregnancy study (n=65) evaluated detection relative to Expected Menstrual Period (EMP), showing 76.9% sensitivity at EMP-5 and 100% at EMP-3. Analytical performance confirmed 10 mIU/mL sensitivity, no hook effect up to 500,000 mIU/mL, and no interference from common substances, pH (4-9), or urine density.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: test strip, plastic housing, absorbent tip. Sensitivity: 10 mIU/mL. Calibration: WHO International Standard 5th edition (NIBSC 07/364). Stability: 24 months at 35.6-86°F. No electronic components or software.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid early pregnancy detection in women. Intended for home-use.

Regulatory Classification

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. 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.

Predicate Devices

• Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (K150022)

Submission Summary (Full Text)

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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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 5, 2024

Aceso Laboratories, Inc. % Joe Shia Director LSI International Inc 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

#### Re: K234152

Trade/Device Name: ACESO Early Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: February 22, 2024 Received: February 22, 2024

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 (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/cdrb/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-devices/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 [phone] 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) K234152

Device Name ACESO Early Pregnancy Test

#### Indications for Use (Describe)

ACESO Early Pregnancy Test 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.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY K234152

| 1. | Date: | March 22, 2024 |
|----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter: | Aceso Laboratories, Inc.<br>14020 Central Avenue<br>Suite 520<br>Chino, CA 91710 |
| 3. | Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite H<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 4. | Device Name: | ACESO Early Pregnancy Test |
| | Classification: | Class II |
| | Product Code: | LCX |
| | CFR: | 862.1155 |
| 5. | Predicate Devices: | Wondfo One Step HCG Urine Pregnancy Test<br>Midstream, Wondfo One Step HCG Urine Pregnancy<br>Test Strip, Wondfo One Step HCG Urine Pregnancy Tes<br>Cassette, K150022 |

#### 6. Intended Use

ACESO Early Pregnancy Test 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.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

#### Device Description 7.

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ACESO Early Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is 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 device is in a ready-to- use format.

| Similarities | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Item | Candidate device | Predicate device |
| Intended use | A rapid chromatographic<br>immunoassay for the<br>qualitative detection of<br>human chorionic<br>gonadotropin (hCG) in<br>urine, as an aid in early<br>detection of pregnancy, in<br>some cases as early as five<br>(5) days before the expected<br>period, i.e., as early as six<br>(6) days before the day of<br>the missed period. | Same |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic<br>assay | Immunochromatographic<br>assay |
| 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

ACESO Early Pregnancy Test is 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. The complex migrates along 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

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regardless of the test result.

## 10. Performance Characteristics

## A. Analytical nerformance

### a. Precision/Reproducibility/Sensitivity

Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 3, 5, 8, 10, 15, 25 and 50 mIU/mL. Each sample was tested by both dip and midstream methods in 10 replicates per day for 10 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 are summarized in the table below:

| hCG<br>Concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total<br>result | | %<br>Negative | %<br>Positive |
|----------------------------------|-------|----|-------|----|-------|----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 5 | 24 | 26 | 23 | 27 | 27 | 23 | 74 | 76 | 49% | 51% |
| 8 | 3 | 47 | 2 | 48 | 2 | 48 | 7 | 143 | 5% | 95% |
| 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% |

Midstream Testing

Dip Testing

| hCG<br>Concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
|----------------------------------|-------|----|-------|----|-------|----|--------------|-----|------------|------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 5 | 26 | 24 | 24 | 26 | 26 | 24 | 76 | 74 | 51% | 49% |
| 8 | 2 | 48 | 1 | 49 | 2 | 48 | 5 | 145 | 3% | 97% |
| 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% |

ACESO Early Pregnancy Test exhibited reproducible results. Based on the above results, the sensitivity of ACESO Early Pregnancy Test is demonstrated to be 10 mIU/mL.

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#### b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test.

#### 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:

ACESO Early Pregnancy Test is 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 35.6-86°F, 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, 3 and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 uIU/mL hTSH). No cross-reactivity was observed at tested concentration.

To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 3 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. The performance of ACESO Early Pregnancy Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.

#### f. Interfering substance

To evaluate potential interferers with ACESO Early Pregnancy Test, urine samples containing 0, 3 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 |
|-----------|---------------|
|-----------|---------------|

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| 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 |
| ẞ-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 ACESO Early Pregnancy Test, urine samples containing 0, 3 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 ACESO Early Pregnancy Test.

To evaluate the effect of urine density on the results of ACESO Early Pregnancy Test, urine samples containing 0, 3 and 10 mIU/mL hCG were tested at density values of 1.000, 1.009, 1.015, 1.017, 1.020, 1.022, 1.028 and 1.035. The results indicated that urine with a relative density of 1.035 does not affect the performance of ACESO Early Pregnancy Test.

#### B. Method comparison study

#### Method comparison with predicate device

The performance of the new device was compared to the predicate test. Urine samples were collected from 100 women presenting to test for pregnancy. Approximately half of the 100 women were suspected to be pregnant in the early stage of less than 5 weeks. All samples were tested with candidate and predicate

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#### devices at three POC sites.

Dip Testing

| Pregnancy Test<br>(ACESO) | Predicate Test<br>(Wondfo test) | | Total |
|---------------------------|---------------------------------|--------------|-------|
| | Positive (+) | Negative (-) | |
| Positive (+) | 53 | 0 | 53 |
| Negative (-) | 0 | 47 | 47 |
| Total | 53 | 47 | 100 |

## Midstream Testing

| Pregnancy Test<br>(ACESO) | Predicate Test<br>(Wondfo test) | | Total |
|---------------------------|---------------------------------|--------------|-------|
| | Positive (+) | Negative (-) | |
| Positive (+) | 53 | 0 | 53 |
| Negative (-) | 0 | 47 | 47 |
| Total | 53 | 47 | 100 |

The conformity between ACESO Early Pregnancy Test and the predicate device is 100%.

## C. Lay person study

100 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

| | Professional Result | | | |
|-----------------|---------------------|----------|-------|-----|
| ACESO | Positive | Negative | Total | |
| Lay user Result | Positive | 53 | 0 | 53 |
| | Negative | 0 | 47 | 47 |
| Total | | 53 | 47 | 100 |

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

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Spiked urine samples were also tested by lay person. Urine samples were prepared at 3mIU/ml, 5mIU/ml, 8mIU/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 100 lay persons.

| hCG<br>Concentrations | Lay person results | | Professional results | | Percent<br>Agreement |
|-----------------------|--------------------|--------------------|----------------------|--------------------|----------------------|
| | No. of<br>Negative | No. of<br>Positive | No. of<br>Negative | No. of<br>Positive | |
| 3 mIU/ml | 100 | 0 | 100 | 0 | 100% |
| 5 mIU/ml | 52 | 48 | 49 | 51 | 97% |
| 8 mIU/ml | 4 | 96 | 5 | 95 | 99% |
| 10mIU/ml | 0 | 100 | 0 | 100 | 100% |

| | Lay person vs Professional |
|--|----------------------------|
| | |

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 650 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 both in-stream and dip methods using three lots of the device. The new device detected 76% 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 test methods. The following table is the summary of the data.

| Day relative to<br>Expected Menstrual<br>Period(EMP) | Number of<br>Positive | Number of<br>Negative | Number of<br>Total | % Positive |
|------------------------------------------------------|-----------------------|-----------------------|--------------------|------------|
| EMP-8 | 6 | 59 | 65 | 9.2% |
| EMP-7 | 16 | 49 | 65 | 24.6% |
| EMP-6 | 31 | 34 | 65 | 47.7% |
| EMP-5 | 50 | 15 | 65 | 76.9% |
| EMP-4 | 63 | 2 | 65 | 96.9% |
| EMP-3 | 65 | 0 | 65 | 100.0% |
| EMP-2 | 65 | 0 | 65 | 100.0% |
| EMP-1 | 65 | 0 | 65 | 100.0% |
| EMP | 65 | 0 | 65 | 100.0% |
| EMP+1 | 65 | 0 | 65 | 100.0% |

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#### 11. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the device, it's concluded that ACESO Early Pregnancy Test is substantially equivalent to the predicate.