FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 5, 2024 Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877 #### Re: K233174 Trade/Device Name: FaStep™ Pregnancy Rapid Test Strip; FaStepTM 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: December 19, 2023 Received: December 19, 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) 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 Division Deputy 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K233174 Device Name FaStep™ Pregnancy Rapid Test Strip FaStepTM Pregnancy Rapid Test Midstream #### Indications for Use (Describe) The FaStep" Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use. The FaStep M Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Midstream is designed for self-testing use. 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) #### 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 | | | K233174 | |----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Date: | February 5, 2024 | | 2. | Submitter: | Assure Tech. (Hangzhou) Co., Ltd.<br>2nd. Floor, Building 1, No.10, Xiyuansan Road<br>Westlake Economic Zone, Hangzhou, 310030<br>China | | 3. | Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite H<br>Gaithersburg, MD 20877<br>Telephone: 240-505-7880<br>Fax: 301-916-6213<br>Email: shiajl@yahoo.com | | 4. | Device Name: | FaStep™ Pregnancy Rapid Test Strip<br>FaStep™ Pregnancy Rapid Test Midstream | | | Classification: | Class II | | | Product Code: | LCX | | | CFR: | 862.1155 | | 5. | Predicate Devices: | Fastep™ At-Home Pregnancy Test<br>(K122907) | #### 6. Intended Use The FaStep™ Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use. The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStepTM Pregnancy Rapid Test Midstream is designed for self-testing use. #### 7. Device Description FaStepTM Pregnancy Rapid Test Strip is sold as a strip format and FaStepTM {4}------------------------------------------------ FaStep™ Pregnancy Rapid Test Midstream is sold as a midstream format. Pregnancy Rapid Test Midstream consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep™ Pregnancy Rapid Test Strip is a single test strip. FaStep™ Pregnancy Rapid Test Midstream contains one test sealed in a desiccated aluminum pouch and Instructions for Use. FaStep™ Pregnancy Rapid Test Strip contains one test strip sealed in a desiccated aluminum pouch and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use. | Similarities | | | |-----------------|------------------------------|------------------------------| | Item | Candidate device | Predicate device | | Intended use | Early detection of pregnancy | Early detection of pregnancy | | Specimen | Urine | Urine | | Assay technical | Immunochromatographic assay | Immunochromatographic assay | | Sensitivity | 20 mIU/mL | 20 mIU/mL | | Results | Qualitative | Qualitative | | Read time | 3-10 minutes | 3-5 minutes | | Device format | Midstream, Strip | Midstream | | Target user | Over the counter use | For over-the-counter | Substantial Equivalence Information 8. #### Test Principle 9. FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream use lateral flow immunoassay for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. If hCG is present in the sample, it will reach the Test Zone ("T") of the membrane and form a colored line. When the test is performed properly, a colored line will always appear in the Control Zone ("C"). The test result is shown on the strip (for the strip version) or in the result window (for the midstream version) and read visually between 3 and 10 minutes of urine application. Two distinct colored lines, one in the Test Zone and another in the Control Zone indicate a positive test result (pregnant). Absence of a colored line in the Test Zone and only a colored line in the Control Zone indicates a negative test result (not pregnant). Absence of a colored line in the Control Zone even in the presence of a colored line in the Test Zone indicates an invalid test result. #### 10. Performance Characteristics {5}------------------------------------------------ # 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, 10, 12.5, 15, 17.5, 20, 50, 100 and 200 mIU/mL. Each sample was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format 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) | Operator 1<br>Lot 1 | | Operator 2<br>Lot 2 | | Operator 3<br>Lot 3 | | Total<br>result | | %<br>Negative | %<br>Positive | |----------------------------------|---------------------|----|---------------------|----|---------------------|----|-----------------|-----|---------------|---------------| | | - | + | - | + | - | + | - | + | | | | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 12.5 | 46 | 4 | 45 | 5 | 43 | 7 | 134 | 16 | 89.3% | 10.7% | | 15 | 22 | 28 | 27 | 23 | 25 | 25 | 74 | 76 | 49.3% | 50.7% | | 17.5 | 6 | 44 | 6 | 44 | 5 | 45 | 17 | 133 | 11.3% | 88.7% | | 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | FaStepTM Pregnancy Rapid Test Midstream (in-stream method) ### FaStep™ Pregnancy Rapid Test Midstream format (dip method) | hCG<br>Concentration<br>(mIU/mL) | Operator<br>1<br>Lot 1 | | Operator<br>2<br>Lot 2 | | Operator<br>3<br>Lot 3 | | Total<br>result | | %<br>Negative | %<br>Positive | |----------------------------------|------------------------|----|------------------------|----|------------------------|----|-----------------|-----|---------------|---------------| | | - | + | - | + | - | + | - | + | | | | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 12.5 | 44 | 6 | 44 | 6 | 46 | 4 | 134 | 16 | 89.3% | 10.7% | | 15 | 24 | 26 | 26 | 24 | 27 | 23 | 77 | 73 | 51.3% | 48.7% | | 17.5 | 7 | 43 | 5 | 45 | 4 | 46 | 16 | 134 | 10.7% | 89.3% | | 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | #### FaStep™ Pregnancy Rapid Test Strip | hCG<br>Concentration | Operator<br>1 | Operator<br>2 | Operator<br>3 | Total<br>result | %<br>Negative | %<br>Positive | |----------------------|---------------|---------------|---------------|-----------------|---------------|---------------| |----------------------|---------------|---------------|---------------|-----------------|---------------|---------------| {6}------------------------------------------------ | (mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | | | | | |----------|-------|----|-------|----|-------|----|-----|-----|-------|-------| | | - | + | - | + | - | + | - | + | | | | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% | | 12.5 | 45 | 5 | 45 | 5 | 44 | 6 | 134 | 16 | 89.3% | 10.7% | | 15 | 23 | 27 | 26 | 24 | 24 | 26 | 73 | 77 | 48.7% | 51.3% | | 17.5 | 7 | 43 | 5 | 45 | 6 | 44 | 18 | 132 | 12.0% | 88.0% | | 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | | 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% | FaStepTM Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream exhibited reproducibility of results. Based on the above results, the sensitivity of FaStep™ Pregnancy Rapid Test is demonstrated to be 20 mIU/mL. #### b. Linearity/assay reportable range: Linearity is not applicable since this is a qualitative test. #### 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. # c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream are calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364. #### Stability: A 27-month real time stability test was carried out to verify the shelf-life stability of the device. Three batches for each format in sealed foil pouch are stable for 30 months at 2℃ and 30℃, and the shelf-life is claimed to be 24 months. #### d. Specificity and cross reactivity To evaluate specificity, 300 urine samples were collected from normal, 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. In each age group, 50 participants were tested with test midstream {7}------------------------------------------------ using dip method, and 50 participants tested with test midstream using in-stream method. No false positive results were observed for any of the age groups. To evaluate cross-reactivity, negative and positive urine samples (0, 10 and 20 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 10 mIU/mL hCG) and positive urine samples (20 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 FaStep™ Pregnancy Rapid Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L. #### e. Interfering substance To evaluate potential interference with FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 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 Acid | 20 mg/dL | | Albumin | 2000 mg/dL | | Amoxicillin | 20 mg/dL | | Ampicillin | 20 mg/dL | | Ascorbic acid | 20 mg/dL | | Aspirin | 80 mg/dL | | Atropine | 20 mg/dL | | Benzoylecgonine | 10 mg/dL | | Bilirubin | 40 mg/dL | | Caffeine | 20 mg/dL | | Cannabinol | 10 mg/dL | | EDTA | 80 mg/dL | | Ephedrine | 20 mg/dL | | Ethanol | 1% | | Folic acid | 0.03 mg/dL | | Gentisic acid | 20 mg/dL | | Glucose | 2000 mg/dL | | Hemoglobin | 1000 mg/dL | | Ibuprofen | 40 mg/dL | | Ketone | 20 mg/dL | {8}------------------------------------------------ | Methanol | 1% | |---------------------|------------| | Phenothiazine | 20 mg/dL | | Phenylpropanolamine | 20 mg/dL | | Pregnanediol | 1.5 mg/dL | | Salicylic Acid | 20 mg/dL | | Tetracycline | 20 mg/dL | | Thiophene | 20 mg/dL | | Uric acid | 23.5 mg/dL | | Vitamin B1 | 80 mg/dL | | β-hydroxybutyrate | 2000 mg/dL | To evaluate the effect of urine pH on the results of FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 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 FaStep™ Pregnancy Rapid Test. To evaluate the effect of urine density on the results of FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.011, 1.015, 1.019, 1.024, 1.029 and 1.035. The results indicated that urine with a relative density of 1.000 to 1.035 does not affect the performance of FaStepTM Pregnancy Rapid Test. #### B. Method comparison study #### Method comparison with predicate device The performance of the FaStepTM Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream was compared to the predicate test. Urine samples were collected from 267 women presenting to test for pregnancy. Total of the 139 women were pregnant and they were all in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites. | Candidate device | | Predicate device | | | |---------------------------------------|----------|------------------|----------|-------| | | | Positive | Negative | Total | | FaStep™ Pregnancy Rapid Test<br>Strip | Positive | 74 | 0 | 74 | | | Negative | 0 | 66 | 66 | | | Total | 74 | 66 | 140 | The results are summarized in the table below. | Candidate device | | Predicate device | Negative | Total | |------------------------------|----------|------------------|----------|-------| | | | Positive | | | | FaStep™ Pregnancy Rapid Test | Positive | 65 | 0 | 65 | | Midstream (in-stream method) | Negative | 0 | 62 | 62 | {9}------------------------------------------------ | | Total | 65 | 62 | 127 | |---------------------------------------------------------|----------|------------------|----------|-------| | Candidate device | | Predicate device | | | | | | Positive | Negative | Total | | FaStepTM Pregnancy Rapid Test<br>Midstream (dip method) | Positive | 65 | 0 | 65 | | | Negative | 0 | 62 | 62 | | | Total | 65 | 62 | 127 | The conformity between FaStep™ Pregnancy Rapid Test Strip, FaStep™ Pregnancy Rapid Test Midstream and the predicate device is 100%. ### C. Lay person study 267 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. The results are summarized in the table below. A total of 140 subjects tested their urine samples using the FaStep™ Pregnancy Rapid Strip | FaStep™ Pregnancy Rapid Test Strip | | Professional | | | |------------------------------------|----------|--------------|----------|-------| | | | Positive | Negative | Total | | Layperson | Positive | 74 | 0 | 74 | | | Negative | 0 | 66 | 66 | | | Total | 74 | 66 | 140 | A total of 127 lay users tested their urine samples using the FaStepTM Pregnancy Rapid Midstream. | FaStep™ Pregnancy Rapid Test<br>Midstream<br>(instream and dip method) | | Professional Result | | | |------------------------------------------------------------------------|--------------|---------------------|------------------|-------| | | | Positive<br>(+) | Negative<br>(- ) | Total | | Lay User Result | Positive (+) | 65 | 0 | 65 | | | Negative (-) | 0 | 62 | 62 | | Total | | 65 | 62 | 127 | 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. {10}------------------------------------------------ ## 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 devices, it's concluded that FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream are substantially equivalent to the predicate.