CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

K193132 · Hangzhou Clongene Biotech Co., Ltd. · LCX · Dec 11, 2019 · Clinical Chemistry

Device Facts

• Record ID: K193132
• Device Name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
• Applicant: Hangzhou Clongene Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

Device Story

Lateral flow sandwich immunochromatographic assay; detects hCG hormone in urine. Available in strip, cassette, and midstream formats. Used for early pregnancy detection. Operated by lay users (OTC) or healthcare professionals at point-of-care. User applies urine sample to device; results interpreted visually via color change on test line within 3 minutes. Provides qualitative positive/negative result. Benefits patient by enabling rapid, convenient, early pregnancy confirmation.

Clinical Evidence

Bench testing and lay-user study. Analytical performance: 25 mIU/mL sensitivity; no hook effect up to 2,000,000 mIU/mL; no interference from common exogenous substances, pH (4-9), or specific gravity (1.000-1.035). Method comparison: 120 clinical samples tested by professionals showed 100% positive/negative conformity with predicate. Lay-user study: 300 participants across three sites demonstrated 100% positive/negative conformity with professional results; questionnaire confirmed ease of use and interpretation.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Formats: strip, cassette, midstream. Sensitivity: 25 mIU/mL. Calibrated against WHO 5th International Standard. Shelf-life: 24 months at 4-30°C. No electronic components; non-networked; standalone diagnostic test.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (HCG) in urine for early pregnancy detection in women. Suitable for over-the-counter (OTC) 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.

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 11, 2019

Hangzhou Clongene Biotech Co.,Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877

Re: K193132

Trade/Device Name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 8, 2019 Received: November 12, 2019

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality CDRH | Food and Drug Administration

Enclosure

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# Indications for Use

510(k) Number (if known) k193132

Device Name

CLUNGENE HCG Pregnancy Rapid Test Cassette CLUNGENE HCG Pregnancy Rapid Test Strip CLUNGENE HCG Pregnancy Rapid Test Midstream

Indications for Use (Describe)

The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K193132

# 510(k) SUMMARY

| 1. Date: | December 09, 2019 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Hangzhou Clongene Biotech Co., Ltd.<br>20 Longquan Road<br>Hangzhou 311121, China<br>Telephone: [phone]<br>Fax: [phone] |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite J<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email:[e-mail] |
| 4. Device Name: | CLUNGENE HCG Pregnancy Rapid Test Cassette<br>CLUNGENE HCG Pregnancy Rapid Test Midstream<br>CLUNGENE HCG Pregnancy Rapid Test Strip |
| Classification: | Class II |

| Product Code | CFR # | Panel |
|--------------|--------------------------------------------------------------------|----------------------------|
| LCX | 21 CFR, 862.1155 Human chorionic gonadotropin<br>(hCG) Test System | Clinical<br>Chemistry (75) |

- 5. Predicate Devices: EGENS One Step HCG Urine Pregnancy Test (K123050)
#### 6. Intended Use

CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

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#### 7. Device Description

Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.

| Similarities | | |
|-----------------|---------------------------------|---------------------------------|
| Item | Candidate device | Predicate device K123050 |
| Intended use | Early detection of<br>pregnancy | Early detection of<br>pregnancy |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic<br>assay | Immunochromatographic<br>assay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Differences | | |
| Item | Device | Predicate |
| Reading Time | 3 minute | 5 minute |

#### Substantial Equivalence Information 8.

#### Standard/Guidance Document Reference (if applicable) 9.

Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, July 22, 2000

# 10. Test Principle

This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine, using a lateral flow sandwich immunochromatographic assay.

# 11. Performance Characteristics

# A. Analytical performance

# a. Precision/Reproducibility/Sensitivity

Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:

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#### Strip format

| hCG<br>Concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %<br>Negative | %<br>Positive |
|----------------------------------|-------|----|-------|----|-------|----|--------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 25 | 5 | 25 | 5 | 72 | 18 | 80 | 20 |
| 22.5 | 13 | 17 | 14 | 16 | 17 | 13 | 44 | 46 | 48.9 | 51.1 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |

#### Cassette format

| hCG<br>Concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %<br>Negative | %<br>Positive |
|----------------------------------|-------|----|-------|----|-------|----|--------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 24 | 6 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 13 | 17 | 13 | 17 | 41 | 49 | 45.6 | 54.4 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |

## Midstream format

| hCG<br>Concentration<br>(mIU/mL) | | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %<br>Negative | %<br>Positive |
|----------------------------------|----|-------|----|-------|----|-------|----|--------------|------|---------------|---------------|
| | | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 18.75 | 23 | 7 | 23 | 7 | 25 | 5 | 71 | 19 | 78.9 | 21.1 | |
| 22.5 | 16 | 14 | 17 | 13 | 14 | 16 | 47 | 43 | 52.2 | 47.8 | |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |

Based on the above results, the sensitivity of CLUNGENE HCG Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.

# b. Linearity/assay reportable range:

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Linearity is not applicable since this is a qualitative test.

### c. Hook effect test:

Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 62500 to 2000,000 mIU/mL.

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

CLUNGENE HCG Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition.

A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are ongoing.

#### e. Specificity and cross reactivity

To evaluate specificity and cross-reactivity, negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.

### f. Interfering substance

To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.

| Substances | Concentration |
|----------------------|---------------|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Asorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Salicylic Acid | 20mg/dL |
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |

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| Albumin | 2000mg/dL |
|-----------------|-----------|
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |

To evaluate potential interference from changes in pH, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.

To evaluate potential interference from changes in specific gravity, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.000 to 1.035. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.

# 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 120 women presenting to test for pregnancy. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by three different health professionals for each format at the 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.

| Strip Format | | Predicate device | |
|---------------------------------------|----------|------------------|----------|
| | | Positive | Negative |
| CLUNGENE HCG®<br>Rapid Pregnancy Test | Positive | 63 | 0 |
| | Negative | 0 | 57 |

| | | Predicate device | |
|---------------------------------------|----------|------------------|----------|
| Cassette | | Positive | Negative |
| CLUNGENE HCG®<br>Rapid Pregnancy Test | Positive | 63 | 0 |
| | Negative | 0 | 57 |

| Midstream | Predicate device | |
|-----------|------------------|----------|
| | Positive | Negative |

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| CLUNGENE HCG®<br>Rapid Pregnancy Test | Positive | 63 | 0 |
|---------------------------------------|----------|----|----|
| | Negative | 0 | 57 |

Conclusion from the above table:

The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%

# C. Lay person study:

300 women's individual pregnancy status was self-tested, 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

| Rapid Pregnancy Test Strip | Professional | | |
|----------------------------|--------------|----|----|
| | + | - | |
| Lay person | + | 43 | 0 |
| | - | 0 | 57 |

| Rapid Pregnancy Test Cassette | Professional | | |
|-------------------------------|--------------|----|----|
| | + | - | |
| Lay person | + | 53 | 0 |
| | - | 0 | 47 |

| Rapid Pregnancy Test Midstream | | Professional | |
|--------------------------------|---|--------------|----|
| | | + | - |
| Lay person | + | 50 | 0 |
| | - | 0 | 50 |

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

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.

### 12. Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.