Alltest Pregnancy Rapid Combo Test Cassette

K203272 · Hangzhou AllTest Biotech Co., Ltd. · JHI · Jan 31, 2022 · Clinical Chemistry

Device Facts

• Record ID: K203272
• Device Name: Alltest Pregnancy Rapid Combo Test Cassette
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jan 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Alltest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Story

The Alltest Pregnancy Rapid Combo Test Cassette is a lateral flow chromatographic immunoassay used for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum samples. The device is operated by healthcare professionals in point-of-care settings. The test utilizes a sandwich immunoassay principle where the sample is absorbed into the device via capillary action and mixes with a mouse anti-beta hCG monoclonal antibody-dye conjugate. The mixture flows across a membrane precoated with goat anti-hCG polyclonal antibody. If hCG is present at or above the cut-off concentration (10 mIU/mL for serum; 20 mIU/mL for urine), a colored test line appears, indicating a positive result. The absence of a test line indicates a negative result. A control line confirms proper flow. The device provides a visual qualitative result that aids clinicians in the early detection of pregnancy.

Clinical Evidence

Method comparison study performed at three POC sites with 212 women (ages 20-49). 107 serum and 105 urine samples tested by healthcare professionals using candidate and predicate devices. Results showed 100% agreement between candidate and predicate for both matrices. Analytical performance included precision, specificity, interference, and hook effect studies using spiked samples traceable to WHO 5th IS 07/364.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: absorbent pad, coated membrane, gold conjugate pad, sample pad. Analyte: hCG. Cut-offs: 10 mIU/mL (serum), 20 mIU/mL (urine). Traceable to WHO 5th International Standard 07/364. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. Intended for use by healthcare professionals, including at point-of-care settings.

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

• Fastep S10 Hcg Serum/urine Combo Test (K132834)

Submission Summary (Full Text)

{0}------------------------------------------------

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

January 31, 2022

Hangzhou AllTest Biotech Co., Ltd % Joe Shia Director LSI International Inc 504E Diamond Ave, Suite J Gaithersburg, Maryland 20877

Re: K203272

Trade/Device Name: Alltest Pregnancy Rapid Combo Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: JHI Dated: November 1, 2021 Received: November 2, 2021

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.

{1}------------------------------------------------

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 medical devices and radiation-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. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) k203272

Device Name Alltest Pregnancy Rapid Combo Test Cassette

Indications for Use (Describe)

The Altest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

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

| <div>☑ Prescription Use (Rx) (21 CFR 201.100(b))</div> | <div>☐ Over-The-Counter Use (21 CFR 201.66)</div> |
|--------------------------------------------------------|---------------------------------------------------|
|--------------------------------------------------------|---------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY K203272

| 1. Date: | December 23, 2021 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Hangzhou AllTest Biotech Co., Ltd.<br>No. 550, Yinhai Street<br>Hangzhou, China, 310018 |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite I<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email:[e-mail] |

- 4. Device Name: Alltest Pregnancy Rapid Combo Test Cassette
Classification: ClassII

| Product<br>Code | CFR # | Panel |
|-----------------|-------------------------------------------------------------|--------------------|
| JHI | 862.1155, Human chorionic<br>gonadotropin (HCG) test system | Clinical Chemistry |

- 5. Predicate Devices:
k132834, Clarity Diagnostics Clarity hCG Pregnancy Combo Test Cassette

- 6. Intended Use
The Alltest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.

The test is for health care professionals use including professionals at point of care (POC).

- 7. Device Description
The Alltest Pregnancy Rapid Combo Test Cassette measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

- 8. Substantial Equivalence Information

{4}------------------------------------------------

A summary comparison of features of the Alltest Pregnancy Rapid Combo Test Cassette and the predicate device is provided in the following table.

| Item | Device | Predicate |
|-------------------|--------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | Rapid qualitative detection of<br>hCG to aid in the early detection<br>of pregnancy. | Same |
| Specimen | Urine or serum | Same |
| Principle | Lateral flow Sandwich<br>Immunochromatographic Assay | Same |
| Detection reagent | Colloidal gold | Same |
| Read time | Serum: 5 minutes Urine:<br>3 minutes | 5 minutes for both<br>serum and urine |
| Usage | For prescription use | Same |
| Cut-Off Values | 10 mIU/mL for serum and 20<br>mIU/mL for urine | Same |
| Configurations | Cassette | Same |
| Storage | 2 – 30°C | Same |

# 9. Test Principle

It is a lateral flow chromatographic immunoassay. When a sample is added, the sample is absorbed into the device by capillary action and mixes with the antibodydye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the precoated (Goat anti HCG polyclonal antibody) membrane. At analyte concentration above the target cut off, it produces a colored test line that indicates a positive result. When analyte concentration is below the cutoff, no colored band shows in the test region, indicating a negative result. No line in the "C" region indicates that the test is invalid.

## 10. Performance Characteristics

## Analytical Performance

- a. Precision/Reproducibility/Cut-Off Value
Negative serum or urine specimens were spiked with varying hCG (commercially available and traceable to the 5th WHO international Standard) concentrations. The spiked samples were measured in 6 replicates each day for 5 days using 3 different lots at three testing sites. Tests were performed by six different operators for each sample concentration. Results are shown in the following tables.

| hCG<br>Concentration | Site 1<br>Lot 2 | Site 2<br>Lot 3 | Site 3<br>Lot 1 | Total<br>result | %<br>Negative | %<br>Positive |
|----------------------|-----------------|-----------------|-----------------|-----------------|---------------|---------------|
|----------------------|-----------------|-----------------|-----------------|-----------------|---------------|---------------|

#### Serum

{5}------------------------------------------------

| (mIU/mL) | - | + | - | + | - | + | - | + | - | + |
|----------|----|----|----|----|----|----|----|----|------|------|
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 3 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 8 | 7 | 23 | 7 | 23 | 8 | 22 | 22 | 68 | 24.4 | 75.6 |
| 10 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 12 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 15 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |

#### Urine

| hCG<br>Concentration<br>(mIU/mL) | Site 1<br>Lot 2 | | Site 2<br>Lot 3 | | Site 3<br>Lot 1 | | Total<br>result | | %<br>Negative | %<br>Positive |
|----------------------------------|-----------------|----|-----------------|----|-----------------|----|-----------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 10 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 15 | 15 | 15 | 16 | 14 | 15 | 15 | 46 | 44 | 51.1 | 48.9 |
| 17.5 | 6 | 24 | 6 | 24 | 6 | 24 | 18 | 72 | 20 | 80 |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 30 | 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 |

Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are verified.

## b. Stability

Stable at 2-30°C for 24 months based on the accelerated stability study at 55°C.

## c. Specificity / Cross Reactivity

#### High Dose Effect

Negative urine (serum) samples were spiked with varying high hCG concentrations ranging from 500 to 2,000,000 mIU/mL. The spiked samples were tested by 3 different lots and 3 different operators. No hook effect was observed at these concentrations.

## Effects of hCG ß-core fragment

Negative and positive samples (5 and 10 mIU/mL hCG in serum; 10 and 20 mIU/mL hCG in urine) were spiked with various concentrations of ß -core fragment hCG (0 to 2x106pmol/L). These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. No interference was observed for these samples for the devices except that false positive was observed above the 100 pmol/L ß -core fragment hCG.

{6}------------------------------------------------

# Effects of glycoprotein LH, FSH and TSH

Negative and positive samples (10 and 20 mIU/mL hCG for urine, and 5 and 10 mIU/mL hCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. No interference was observed for these samples for the device at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 uIU/mL.

## d. Interference

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG negative (5mIU/mL for serum, 10mIU/mL for urine) and hCG positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table.

| Interferents | Concentration | Negative hCG | | | Positive hCG | | |
|---------------------|---------------|--------------|------|------|--------------|------|------|
| | | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 |
| Acetaminophen | 20 mg/dl | - | - | - | + | + | + |
| Acetoacetic Acid | 2000 mg/dl | - | - | - | + | + | + |
| Ascorbic Acid | 20 mg/dl | - | - | - | + | + | + |
| Atropine | 20 mg/dl | - | - | - | + | + | + |
| Acetosalicylic Acid | 20 mg/dl | - | - | - | + | + | + |
| Albumin | 2000mg/dl | - | - | - | + | + | + |
| Bilirubin | 2mg/dl | - | - | - | + | + | + |
| Caffeine | 20 mg/dl | - | - | - | + | + | + |
| Codeine | 10mg/dl | - | - | - | + | + | + |
| Ephedrine | 20 mg/dl | - | - | - | + | + | + |
| EDTA | 80 mg/dl | - | - | - | + | + | + |
| Ethanol | 1% | - | - | - | + | + | + |
| Gentisic Acid | 20 mg/dl | - | - | - | + | + | + |
| Glucose | 2000mg/dl | - | - | - | + | + | + |
| Hemoglobin | 2000mg/dl | - | - | - | + | + | + |
| Methadone | 10mg/dl | - | - | - | + | + | + |
| Phenylpropanolamine | 20 mg/dl | - | - | - | + | + | + |
| Phenothiazine | 20 mg/dl | - | - | - | + | + | + |
| Pregnanediol | 1.5 mg/dl | - | - | - | + | + | + |
| Salicylic Acid | 20 mg/dl | - | - | - | + | + | + |
| B-hydroxybutyrate | 2000mg/dL | - | - | - | + | + | + |
| Benzoylecgonine | 10mg/dL | - | - | - | + | + | + |
| Cannabinol | 10mg/dL | - | - | - | + | + | + |
| Methanol | 10% | - | - | - | + | + | + |

{7}------------------------------------------------

| Estriol-17-beta | 1.4mg/dL | - | - | - | + | + | + |
|---------------------------------------|-----------|---|---|---|---|---|---|
| Thiophene | 20mg/dl | - | - | - | + | + | + |
| Ampicillin | 20mg/dl | - | - | - | + | + | + |
| Tetracycline | 20mg/dl | - | - | - | + | + | + |
| Ketone | 20mg/dl | - | - | - | + | + | + |
| Total cholesterol (serum only ) | 250mg/dl | - | - | - | + | + | + |
| Triglycerides (serum only ) | 1200mg/dl | - | - | - | + | + | + |
| High-density lipoprotein (serum only) | 70mg/dl | - | - | - | + | + | + |

All data show that there is no interference for the listed compounds at the stated concentrations.

# e.Effect of Urine Specified Gravity and Urine pH

Negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested at pH values from 4 to 9 or at density values ranging from 1.001 to1.035 using 3 different lots by 3 different operators. Data show that there is no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.001 to 1.035 of tested urine samples.

# 2. Comparison Studies

A method comparison study was performed, comparing the results obtained from the Alltest hCG Pregnancy Rapid Combo Test Cassette to the results from predicate devices (k132834). 105 urine and 107 serum samples were collected from 212 women (about half of them were pregnant, early stage at less than 5 weeks) from three testing Samples were randomly collected at various times throughout the day. Ages sites. ranged from 20 to 49 years. Samples were tested by different health professionals with the proposed and the predicate devices at each site. The obtained results are shown in the following tables.

## Summary Results for Urine Cassette

| New Device | Cleared device | |
|------------|----------------|----|
| | + | - |
| + | 53 | 0 |
| - | 0 | 52 |

## Summary Results for Serum Cassette

| | Cleared device | + | - |
|------------|----------------|----|----|
| New Device | + | 58 | 0 |
| | - | 0 | 49 |

The study result shows that 100% agreement for all samples.

- 3. Clinical Studies
Not applicable

#### 11.Conclusion

{8}------------------------------------------------

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Alltest hCG Pregnancy Serum/Urine Combo Test Cassette is substantially equivalent to the predicate.