(151 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay that relies on visual interpretation of colored lines, with no mention of AI or ML components.
No
The device is an in vitro diagnostic (IVD) device used for the qualitative detection of human chorionic gonadotropin (hCG) to aid in early detection of pregnancy, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy" and is "For in Vitro Diagnostic Use Only." This directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "rapid, one-step lateral flow immunoassay" and describes physical components like a "test strip assembled in a plastic card, with an absorbent tip" and "aluminum foil pouch," indicating it is a physical in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "For in Vitro Diagnostic Use Only." This is a clear indicator that the device is intended for use outside of the body to examine specimens (in this case, urine) to provide information for the diagnosis of a condition (pregnancy).
N/A
Intended Use / Indications for Use
The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The HCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The HCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
LCX, JHI
Device Description
The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines.
The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use.
For over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
- Precision / Reproducibility/Sensitivity:
- Urine samples from non-pregnant females (negative) were spiked with 0 mIU/mL, 12.5 mIU/mL, 25 mIU/mL, 37.5 mIU/mL, 50 mIU/mL, and 100 mIU/mL of HCG.
- Three (3) lots of tests (strip/midstream format by immersion sampling method /midstream format by urinate sampling method) were used to test each concentration in replicates of 2 per day, at 3 sites.
- Testing was repeated for 15 days. For each format of the device, a total of 90 replicates were tested for at each HCG concentration.
- Results: All specimens with HCG concentration equal to or higher than 25mIU/mL show positive results, while HCG concentration lower than 25mIU/mL showed some negative results. The sensitivity concentration of the tests is determined to be 25mIU/mL HCG. All devices have 100% positive detection at the claimed sensitivity of 25 mIU/mL and above. There were no significant differences in performance between lots, between sites, between sites, between time of day and between days.
- Traceability: The tests are calibrated against reference material traceable to WHO International Standard 6th edition, NIBSC code 18/244.
- Stability:
- Real time Stability: A 39-month real time stability test is planned to verify the shelf-life stability of the device as 36 months. Three batches for each format in sealed foil pouch are currently stable for 12 months at 2-8°C and 30°C, and the real time stability study is still on-going.
- Accelerated Stability: Stable at 2-30°C for 36 months based on the accelerated stability study at 55°C for 46 days and real time stability determination at both 2-8℃ and 30℃.
- Analytical specificity (Cross-Reactivity):
- The candidate devices were tested for potential cross-reactivity from luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH).
- Each potential cross-reactant was spiked into a negative pooled human urine sample (control) and two positive pooled human urine samples containing 25mlU/ml HGG and 100mIU/mL HCG (test).
- Test and control samples were tested in replicates of 15 on 3 lots of the candidate device for each format (5replicates tested by each lot).
- Results: The tests do not interference at 500mIU/mL LH, 1000mIU/mL FSH or 1000µIU/mL TSH.
- Interference Study:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- All samples were spiked with final concentrations of potential interferents. For each condition 15 replicates were tested on 3 device lots of each format (5 replicates tested by each lot).
- Results: No interference from substances at the concentrations shown in Table 8.
- Effect of HCG ß-core fragment:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples). The positive samples were then spiked with HCG ß-core fragment at concentrations of 62500, 125000, 50000, 1000000 pmol/L.
- All samples were tested in 15 replicates on 3 device lots of each format (5 replicates tested by each lot).
- Results: The candidate devices are not affected by concentrations of HCG ß-core fragment up to 1000,000 pmol/L.
- Effect of urine pH:
- Urine samples containing 0 mIU/mL and 25 mlU/mL HCG were tested in 15 replicates on 3 lots each format of device (5 replicates tested by each lot) using samples at pH values of 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0.
- Results: Samples within the pH range of 4.0-9.0 do not interfere with either positive or negative results from the devices.
- Effect of urine specific gravity:
- Urine samples containing 0 mIU/mL and 25 mIU/mL HCG were tested in 15 replicates on 3 lots each format of device (5 replicates tested by each lot) using samples at specific gravity values of 1.000, 1.025, 1.026, 1.026, 1.031, 1.035.
- Results: Samples within the specific gravity range of 1.000-1.035 do not interfere with either positive or negative results from the devices.
- High dose hook effect study:
- Urine samples from non-pregnant females (negative samples) were used to prepared samples with HCG concentrations of 25mIU/mL, 100mIU/mL, 1IU/mL, 100IU/mL, 1000IU/mL, and 2000IU/mL HCG, each concentration of the samples was test in 15 replicates on 3lots of each format of the device (5replicates tested by each lot).
- Results: No hook effect at HCG concentrations up to 2000 IU/mL.
- Read Time Flex:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- All samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes, 10 minutes, and 30 minutes after sample addition.
- Results: The test results all met criteria acceptance at 3min~30min and the background was clear. Recommended reading the results at 3 – 10 minutes and do not read the result after 10 minutes.
- Temperature Flex:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mlU/mL HCG (positive samples).
- The tests were equilibrated for 2 hours in 2-8°C, 10-30°C, and 37°C. All samples were tested in 5 replicates by 1 lot of above 3 different equilibrated devices of each format and then read the results at 3 minutes, 5 minutes, and 10 minutes after sample addition.
- Results: When test at 2~30°C, the results were not obvious difference and meet the criteria acceptance. So, the test can be operated at home situation.
- Sample Volume Flex:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- Strip test: dip absorbent tip for 3s, 5s, 10s, and 15s.
- Midstream test (immersion): dip absorbent tip for 8s, 10s, 15s, and 20s.
- Midstream test (simulated urine stream): use a peristaltic pump to simulate urine stream and hold the midstream by the Thumb Grip with the Absorbent tip pointing downward directly into urine stream for 8s, 10s, 15s, and 20s.
- For each condition all samples were tested in 5 replicates and then results at 3 minutes after sample addition.
- Results: The test results all met criteria acceptance when sample addition time was 3s, 5s, 10s, 15s for strip and 8s, 10s, 15s, and 20s for midstream (both immerse sample and simulate urine stream). Recommended to immerse or urinate sample for 10-15s using midstream and to immerse sample for 5-10s using strip.
- Sample Storage study:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- Positive samples were separated in two parts, one part was stored at 2-8°C for 0h and 48h while another part was stored at room temperature (10-30°C) for 0h and 12h.
- All samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes after sample addition.
- Results: The test results all met criteria acceptance when urine sample stored at 10-30℃ for 12 hours and 2-8℃ for 48 hours.
- Sample container material study:
- Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- Samples stored in paper cups (coated), paper cups (uncoated), plastic urine cups and glass cups were tested at 2-8°C for 48h and at room temperature (10-30°C) for 12h.
- For each condition, all samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes after sample addition.
- Results: No sample container material effect was observed when tested with up to a concentration of 0mIU/mL and 25mIU/mL of human chorionic gonadotropin with the test.
Comparison Studies:
- Method comparison with predicate device:
- Study type: Comparison study
- Sample size: 330 women between the age of 18-45.
- Data source: Urine samples from women presenting to test for pregnancy.
- All samples were tested with candidate and predicate devices at three POC sites, each format of device was tested in 3 sites (3 different professionals using the candidate device and the predicate device at each site, totally 9 different professionals conducted the study).
- Key results: The data shows that the agreement of the tests with the predicate device was 100%.
Clinical studies:
- Lay-User Study:
- Study type: Lay user study
- Sample size: 330 volunteers. 110 lay-users for HCG One Step Pregnancy Test Strip OTC, 220 lay-users for HCG one step Pregnancy Test Midstream OTC (111 users performing Immersion sample and 109 users performing Urinate sample).
- Data source: Volunteers with diverse educational and occupational backgrounds between the ages of 18 and 45.
- Lay users tested their own urine sample and provided a sample for professional testing.
- Ease of use of the candidate devices was assessed through a questionnaire.
- Key results: The questionnaire results indicated that lay-users found the tests easy to use, the results clear and easy to read and the instructions for use easy to understand. The data shows that the agreement between lay-user results and professional results was 100%. A Flesch-Kincaid reading analysis of the package insert for the OTC devices shows a reading Grade Level of 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Strip Format Method Comparison:
Sensitivity:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Specificity:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Accuracy:100.00% (110/110), Wilson 95%Cl:96.63%-100.00%.
Positive predictive value:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Negative predictive value:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Midstream Immersion Sample Method Comparison:
Sensitivity:100.00% (59/59), Wilson 95%Cl:93.89%-100.00%.
Specificity:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Accuracy:100.00% (111/111), Wilson 95%Cl:96.65%-100.00%.
Positive predictive value:100.00% (59/59), Wilson 95%Cl:93.89%-100.00%.
Negative predictive value:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Midstream Urinate Sample Method Comparison:
Sensitivity:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Specificity:100.00% (51/51), Wilson 95%Cl:93.00%-100.00%.
Accuracy:100.00% (109/109), Wilson 95%Cl:96.60%-100.00%.
Positive predictive value:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Negative predictive value:100.00% (51/51), Wilson 95%Cl:93.00%-100.00%.
Lay User Study - Strip OTC:
Positive coincidence rate=100%×58/ (58+0)=100.00%,Wilson 95%Cl:93.79%-100.00%.
Negative coincidence rate=100%×52/ (0+52)=100.00%,Wilson 95%Cl:93.12%-100.00%.
Total coincidence rate=100%×(58+52)/ (58+0+0+52)=100.00%,Wilson 95%Cl:96.63%-100.00%.
Lay User Study - Midstream OTC (Immersion sample):
Positive coincidence rate=100%×59/ (59+0)=100.00%,Wilson 95%Cl:93.89%-100.00%.
Negative coincidence rate=100%×52/ (0+52)=100.00%,Wilson 95%Cl:93.12%-100.00%.
Total coincidence rate=100%×(59+52)/ (59+0+0+52)=100.00%,Wilson 95%Cl:96.65%-100.00%.
Lay User Study - Midstream OTC (Urinate sample):
Positive coincidence rate=100%×58/ (58+0)=100.00%,Wilson 95%Cl:93.79%-100.00%.
Negative coincidence rate=100%×51/ (0+51)=100.00%,Wilson 95%Cl:93.00%-100.00%.
Total coincidence rate=100%×(58+51)/ (58+0+0+51)=100.00%,Wilson 95%Cl:96.60%-100.00%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 12, 2024
Hangzhou Aichek Medical Technology Co., Ltd. c/o Dylan Wu, Consultant Shanghai Sungo Management Consulting Co., Ltd. 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K233624
Trade/Device Name: HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX, JHI Dated: February 29, 2024 Received: February 29, 2024
Dear Dylan Wu:
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"
1
(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).
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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Paula V. Caposino -S Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233624
Device Name
HCG One Step Pregnancy Test Strip Rx; HCG One Step Pregnancy Test Midstream Rx
Indications for Use (Describe)
The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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
Indications for Use
510(k) Number (if known) K233624
Device Name
HCG One Step Pregnancy Test Strip OTC HCG One Step Pregnancy Test Midstream OTC
Indications for Use (Describe)
The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
4
510(K) Summary
K233624
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement by 21 CFR 807.92
Date prepared: 9th, Oct 2023
1 Submitter's Information
Name: Hangzhou Aichek Medical Technology Co., Ltd.
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, China
Contact Person: Lisa Liu
Title: Manager of the quality department
Tel: +86-571-89055299
Email: ra.rep@aichek.com
2 Official Contact Person Information
Primary contact: Mr. Dylan Wu
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-18616797137
Email: haiyang.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: zxfda@sungoglobal.com
3 Subject Device
3.1 Trade Name and Regulatory Information:
| No. | Trade name | Regulatory Information |
|---|---|---|
| 1 | HCG One Step Pregnancy Test Strip Rx | |
| 2 | HCG One Step Pregnancy Test Strip OTC | Class II §21 CFR 862.1155 |
| 3 | HCG One Step Pregnancy Test Midstream Rx | Human Chorionic Gonadotropin (HCG) test system |
| 4 | HCG One Step Pregnancy Test Midstream OTC |
3.2 Classification Information
| Product Code | Classification | Description | Panel |
|---|---|---|---|
| LCX | Class II | Kit, test, pregnancy, HCG, over the counter | Clinical Chemistry |
| JHI | Class II | Visual, pregnancy HCG, prescription use | Clinical Chemistry |
4 Predicate device
One Step HCG Urine Pregnancy Test (K043443)
5
5 Indications for use/Intended use
The HCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The HCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The HCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-thecounter use.
The HCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
6 Device Description
The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines.
The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
7 Principle of Operation
The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy.
The test comes in two formats; 1) Midstream, in which a user can apply a specimen by keeping thp in a urine stream for 10-15 seconds or by dipping the absorbent tip (at least 2/3, but not exceed the highest level) into urine collected in a clean and dry container for 10-15 seconds; and 2) test strip format, in which a user dips the absorbent tip(but not exceed the MAX line) into urine collected in a clean and dry container for 5-10 seconds.
After application of the urine specimen, the HCG within the urine reacts with the anti-βHCG antibody-colloidal gold conjugate to form a compound is captured by the anti-αHCG antibody immobilized on the test area, then a colored line will form in the test line region (T) (i.e., test line will always develop in the control line region (C) (i.e., control line) if sufficient sample volume has been applied to the test result is shown in the result window and read visually between 3-10 minutes of urine application.
Two distinct colored lines, one line in the control line region (C) and another in the test line region (T) indicate a positive test result (pregnant). Absence of a colored line in the test line region (T) and only a colored line in the control line region (C) indicates a negative test result (not pregnant). Absence of a colored line in the control line region (C), even in the presence of a colored line in the test line region (T), indicates an invalid test.
6
8 Comparison with the predicate device
8.1 Technological characteristics
| Table 1 Comparison of Technological characteristics | ||
|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Hangzhou Aichek Medical Technology Co., Ltd. | Guangzhou Wondfo Biotech Co., Ltd. | - |
| 510K number | K233624 | K043443 | - |
| Device name | HCG One Step Pregnancy Test Strip Rx | ||
| HCG One Step Pregnancy Test Strip OTC | |||
| HCG One Step Pregnancy Test Midstream Rx | |||
| HCG One Step Pregnancy Test Midstream OTC | One Step HCG Urine Pregnancy Test | Similar | |
| Classification | Class II | Class II | Same |
| Intended use | Aid in early detection of pregnancy. For over-the-counter use and Prescription use. | Aid in early detection of pregnancy. For over-the-counter use and Prescription use. | Same |
| Analyte | Human Chorionic Gonadotrophin (HCG) | Human Chorionic Gonadotrophin (HCG) | Same |
| Specimen Type | Human Urine | Human Urine | Same |
| Technology | Lateral flow immunoassay | Lateral flow immunoassay | Same |
| Basic Components | Test strip containing nitrocellulose membrane, sample pad, alpha and beta HCG antibodies | Test strip containing nitrocellulose membrane, sample pad, alpha and beta HCG antibodies | Same |
| Results | Qualitative | Qualitative | Same |
| Storage Temperature | 2-30°C | 4-30°C | Similar |
| Format | Strip/Midstream | Strip/Cassette/Midstream | Similar |
| Read Time | 3-10minutes | 3-5minutes | Similar |
8.2 Analytical Performance
Table 2 Comparison of Analytical Performance
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K number | K233624 | K043443 | - |
| Analytical Sensitivity | 25 mIU/mL | 25 mIU/mL | Same |
| Analytical Specificity | LH at 500mIU/mL | ||
| FSH at 1000 mIU/mL | |||
| TSH at 1 mIU/mL | LH at 300mIU/mL | ||
| FSH at 300 mIU/mL | |||
| TSH at 1000 mIU/mL | Similar | ||
| High Dosage | |||
| Hook effect | No high dosage hook effect for HCG | ||
| up to 2000000mIU/mL. | No high dosage hook effect for HCG up to | ||
| 100,000 mIU/mL.(100IU/mL) | Similar | ||
| Traceability | WHO 6th International Standard | WHO 3rd International Standard | Similar |
| Urine pH Interference | No interference for urine with pH 4-9 | No interference for urine with pH 4-9 | Same |
| Urine Specific gravity | |||
| Interference | No interference for urine with | ||
| Specific Gravity 1.000-1.035 | No interference for urine with Specific Gravity | ||
| 1.000-1.050 | Similar |
8.3 Substantial Equivalence
The proposed device is substantially equivalent to the predicate device, in terms of intended use, Analyte, Specimen Type, Technology, Basic Components, Results, Format, Analytical Sensitivity (LoD) and Urine pH Interference.
7
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, China The minor difference of analytical performance between the proposed device and the predicate device, i.e., Read Time, Analytical Specificity, High Dosage Hook effect, Storage Temperature, and Urine Specific gravity Interference will not influence the effectiveness of the proposed device.
Therefore, it can be concluded that the proposed device and the proposed device are substantially equivalent.
9 Summary of Non-Clinical Testing
9.1 Analytical performance
Precision / Reproducibility/Sensitivity a
Urine samples from non-pregnant females (negative) were spiked with 0 mIU/mL, 12.5 mIU/mL, 25 mIU/mL, 37.5 mIU/mL, 50 mIU/mL, and 100 mIU/mL of HCG. Three (3) lots of tests (strip/midstream format by immersion sampling method /midstream format by urinate sampling method) were used to test each concentration in replicates of 2 per day, at 3 sites. Testing was repeated for 15 days. For each format of the device, a total of 90 replicates were tested for at each HCG concentration. The results demonstrated that all specimens with HCG concentration equal to or higher than 25mIU/mL show positive results, while HCG concentration lower than 25mIU/mL showed some negative results. Therefore, the sensitivity concentration of the tests is determined to be 25mIU/mL HCG. All devices have 100% positive detection at the claimed sensitivity of 25 mIU/mL and above. There were no significant differences in performance between lots, between sites, between sites, between time of day and between days. Summary of results are presented in the following Table 3 , Table 4 and Table 5.
| Lot 1 | Lot 2 | Lot 3 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HCG | ||||||||||
| Concentration | ||||||||||
| (mIU/mL) | Site 1 | Site 2 | Site 3 | Total Result | % | |||||
| Positive | % | |||||||||
| Negative | ||||||||||
| Operator 1 | Operator 2 | Operator 3 | ||||||||
| + | - | + | - | + | - | + | - | |||
| 0 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 12.5 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 18.75 | 11 | 19 | 12 | 18 | 11 | 19 | 34 | 56 | 37.8% | 62.2% |
| 25 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 37.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 50 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 100 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
Table 3 Precision / Reproducibility /Sensitivity results of Strip Format
| Table 4 Precision / Reproducibility /Sensitivity results of Midstream Format (immersion sampling method) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| ---------------------------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| HCG
Concentration
(mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total Result | | %
Positive | %
Negative |
|----------------------------------|--------|----|--------|----|--------|----|--------------|----|---------------|---------------|
| | Site 1 | | Site 2 | | Site 3 | | | | | |
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 12.5 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 18.75 | 13 | 17 | 12 | 18 | 10 | 20 | 35 | 55 | 38.9% | 61.1% |
| 25 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 37.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 50 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 100 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
8
| Lot 1 | Lot 2 | Lot 3 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HCG | ||||||||||
| Concentration | ||||||||||
| (mIU/mL) | Site 1 | |||||||||
| Operator 1 | Site 2 | |||||||||
| Operator 2 | Site 3 | |||||||||
| Operator 3 | Total Result | % | ||||||||
| Positive | % | |||||||||
| Negative | ||||||||||
| + | - | + | - | + | - | + | - | |||
| 0 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 12.5 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0.0% | 100.0% |
| 18.75 | 13 | 17 | 12 | 18 | 10 | 20 | 35 | 55 | 38.9% | 61.1% |
| 25 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 37.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 50 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
| 100 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100.0% | 0.0% |
Table 5 Precision / Reproducibility /Sensitivity results of Midstream (urinate sampling method)
b Linearity/assay reportable range
Linearity is not applicable since this is a qualitative test.
C Traceability, Stability, Expected values (controls, calibrators, or methods):
c.1 Traceabilitv
The tests are calibrated against reference material traceable to WHO International Standard 6th edition, NIBSC code 18/244
- c.2 Stability
The stability data supports that the products have the shelf life of 36 months when stored at 2-30°C.
Real time Stability
A 39-month real time stability test is planned to verify the shelf-life stability of the device as 36 months. Three batches for each format in sealed foil pouch are currently stable for 12 months at 2-8°C and 30°C, and the real time stability study is still on-going.
Accelerated Stability
Stable at 2-30°C for 36 months based on the accelerated stability study at 55°C for 46 days and real time stability determination at both 2-8℃ and 30℃.
d Detection limit
The detection limit was determined in the precision study (See 9.1.a above)
e Analytical specificity
e.1 Cross-Reactivity
The candidate devices were tested for potential cross-reactivity from luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH). Each potential cross-reactant was spiked into a negative pooled human urine sample (control) and two positive pooled human urine samples containing 25mlU/ml HGG and 100mIU/mL HCG (test). Test and control samples were tested in replicates of 15 on 3 lots of the candidate device for each format (5replicates tested by each lot). Totally n=15 for each concentration of Cross-reactivity substance in each HCG level sample. The results summarized in Table 7 demonstrated that the tests do not interference at 500mIU/mL LH, 1000mIU/mL FSH or 1000µIU/mL TSH.
| Cross-reactivity
| substance | Concentration | HCG (mIU/mL) | ||
|---|---|---|---|---|
| 0 | 25 | 100 |
Table 6 Cross-Reactivity results of Strip Format
9
| + | - | + | - | + | - | ||
|---|---|---|---|---|---|---|---|
| TSH | 500 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| TSH | 750 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| TSH | 1000 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| FSH | 500 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| 750 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 | |
| 1000 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 | |
| LH | 250 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| 500 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 | |
| 750 mIU/mL | 5 | 10 | 15 | 0 | 15 | 0 |
Hangzhou Aichek Medical Technology Co., Ltd. 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, China
| Cross-reactivity
substance | Concentration | HCG (mIU/mL)
0 | | 25 | | 100 | |
|-------------------------------|---------------|-------------------|----|----|---|-----|---|
| | | + | - | + | - | + | - |
| TSH | 500 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| TSH | 750 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| TSH | 1000 µIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| FSH | 500 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| FSH | 750 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| FSH | 1000 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| LH | 250 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| LH | 500 mIU/mL | 0 | 15 | 15 | 0 | 15 | 0 |
| LH | 750 mIU/mL | 8 | 7 | 15 | 0 | 15 | 0 |
Table 7 Cross-Reactivity results of Midstream Format
e.2 Interference Study
To evaluate potential interference for the tests, urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples). All samples were spiked with final concentrations of potential interferents listed in Table 8 below. For each condition 15 replicates were tested on 3 device lots of each format (5replicates tested by each lot). The results demonstrated that no interference from substances at the concentrations shown in Table 8 below.
Table 8 Interfering substances and concentrations
| Interfering Substance | Concentration | Interfering Substance | Concentration |
|---|---|---|---|
| Acetaminophen | 20mg/dL | Hydroxybutyric acid | 2000mg/dL |
| Acetone | 20mg/dL | Ibuprofen | 40mg/dL |
| Acetylsalicylic acid | 20mg/dL | L-ephedrine hydrochloride | 20mg/dL |
| Albumin | 2000mg/dL | Methadone | 20mg/dL |
| Ampicillin | 20mg/dL | Morphin | 10mg/dL |
| Ascorbic acid | 20mg/dL | Nicotine | 10mg/dL |
| Atropine | 20mg/dL | Phenylpropanolamine | 20mg/dL |
| Bilirubin | 2mg/dL | Proephedrine hydrochloride | 20mg/dL |
| Caffeine | 20mg/dL | Salicylic acid | 20mg/dL |
| Cannabinol | 10mg/dL | Tetracycline | 20mg/dL |
| Gentisic acid | 20mg/dL | Uric acid | 20mg/dL |
10
Hangzhou Aichek Medical Technology Co., Ltd. 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zheijang, China
| Interfering Substance | Concentration | Interfering Substance | Concentration |
|---|---|---|---|
| Glucose | 2000mg/dL | Ethanol | 1% |
| Hemoglobin | 250mg/dL | Vitamin B | 800µg/mL |
| Blood urine | 15% |
Effect of HCG ß-core fragment e.3
Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples). The positive samples then were spiked with HCG {}-core fragment at concentrations of 62500, 125000, 50000, 1000000 pmol/L. All samples were tested in 15 replicates on 3 device lots of each format (5replicates tested by each lot). The results demonstrated that the candidate devices are not affected by concentrations of HCG ß-core fragment up to 1000,000 pmol/L.
e.4 Effect of urine pH
To evaluate potential interference from changes in urine samples containing 0 mIU/mL and 25 mlU/mL HCG were tested in 15 replicates on 3 lots each format of device (5replicates tested by each lot) using samples at pH values of 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0. The results demonstrated that samples within the pH range of 4.0-9.0 do not interfere with either positive or negative results from the devices.
e.5 Effect of urine specific gravity
To evaluate potential interference from changes in urine specific gravity, urine samples containing 0 mIU/mL and 25 mIU/mL HCG were tested in 15 replicates on 3 lots each format of device (5 replicates tested by each lot) using samples at specific gravity values of 1.000, 1.025, 1.026, 1.026, 1.031, 1.035. The results demonstrated that samples within the specific gravity range of 1.000-1.035 do not interfere with either positive or negative results from the devices.
e.6 High dose hook effect study
Urine samples from non-pregnant females (negative samples) were used to prepared samples with HCG concentrations of 25mIU/mL, 100mIU/mL, 11U/mL, 1001U/mL, 1000U/mL, and 2000IU/mL HCG, each concentration of the samples was test in 15 replicates on 3lots of each format of the device (5replicates tested by each lot). The test results demonstrated no hook effect at HCG concentrations up to 2000 IU/mL.
f Assay Cut-off
The cutoff for a positive test is 25 mIU/mL. See detection limit in 9.1d.
Read Time Flex g
Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples). All samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes, 10 minutes, and 30 minutes after sample addition. The results summarized in Table 9 indicated that the test results all met criteria acceptance at 3min~30min and the background was clear. We recommend reading the results at 3 – 10 minutes and do not read the result after 10 minutes.
| Sample | 3minutes | 5minutes | 10minutes | 30minutes | ||||
|---|---|---|---|---|---|---|---|---|
| Strip | Midstream | Strip | Midstream | Strip | Midstream | Strip | Midstream | |
| + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
Table 9 Read time flex results of the tests
h Temperature Flex
To determine the operating temperature of the test by studying different operatures. Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples)and 25 mlU/mL
11
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhina HCG (positive samples). The tests were equilibrated for 2 hours in 2-8°C, 10-30°C, and 37°C. All samples were tested in 5 replicates by 1 lot of above 3 different equilibrated devices of each format and then read the results at 3 minutes, 5 minutes, and 10 minutes after sample addition. The results summarized in Table 12 indicated that when test at 2~30°C, the results were not obvious difference and meet the criteria acceptance. So, the test can be operated at home situation.
| Sample | 3minutes | 5minutes | 10minutes | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strip | Midstream | Strip | Midstream | Strip | Midstream | |||||||
| + | - | + | - | + | - | + | - | + | - | + | - | |
| 0 mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25 mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
Table 10 The temperature flex results of the tests: 2-8 ℃
| Table 11 The temperature flex results of the tests: 10-30 °C | ||||||
|---|---|---|---|---|---|---|
| Sample | 3minutes | 5minutes | 10minutes | |||
| Strip | Midstream | Strip | Midstream | Strip | Midstream | |
| + - | + - | + - | + - | + - | + - | |
| 0 mIU/mL HCG | 0 5 | 0 5 | 0 5 | 0 5 | 0 5 | 0 5 |
| 25 mIU/mL HCG | 5 0 | 5 0 | 5 0 | 5 0 | 5 0 | 5 0 |
| Table 12 The temperature flex results of the tests: 37 ℃ | ||
|---|---|---|
| Sample | 3minutes | 5minutes | 10minutes | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Strip | Midstream | Strip | Midstream | Strip | Midstream | |||||
| + | - | + | - | + | - | + | - | + | - | |
| 0 mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25 mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
İ Sample Volume Flex
To determine the appropriate sample volume of the tests by studying different sample volume. Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples).
- Dip only the Absorbent tip (but not exceed the MAX line) of the Strip test into the urine for 3s, 5s, 10s, and 1) 15s.
-
- Dip only the Absorbent tip (at least 2/3, but not exceed the highest level) of the midstream test into the urine for 8s, 10s, 15s, and 20s.
-
- To evaluate product performance and test the tightness of the midstream window. A peristaltic pump was used to simulate urine stream, hold the midstream by the Thumb Grip with the Absorbent tip pointing downward directly into urine stream for 8s, 10s, 15s, and 20s.
- For each condition all samples were tested in 5 replicates and then results at 3 minutes after sample 4) addition.
The results summarized in Table 15 indicated that the test results all met criteria acceptance when sample addition time was 3s, 5s, 10s, 15s for strip and 8s, 10s, 15s, and 20s for midstream (both immerse sample and simulate urine stream). Referring to the instructions for use of similar products on the market, for the convenience of users, we recommended to immerse or urinate sample for 10-15s using midstream and to immerse sample for 5-10s using strip.
12
| Sample | 3s | 5s | 10s | 15s | |||||
|---|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | |||
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | ഗ | 0 | |
| Appearance inspection | No | No | |||||||
| (If sample splash the window) | No | ||||||||
| Table 14 Sample Volume Flex results of the tests: Immerse sample | |||||||||
| 85 | 10s | ||||||||
| Sample | + | - | + | - | + | No | |||
| 15s | |||||||||
| 20s |
5
0
0
ഗ | | | |
| 0mIU/mL HCG | 0 | ഗ | 0 | 5 | 0 | | | 5 | |
| 25mIU/mL HCG | 5 | 0 | ട | 0 | 5 | | | 0 | |
| Appearance inspection
(If sample splash the window) | No | | No | | No | | No | | |
Table 13 Sample Volume Flex results of the tests
Table 15 Sample Volume Flex results of the tests: Simulate urine stream
| Sample | 8s | 10s | 15s | 20s | ||||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
| Appearance inspection | ||||||||
| (If sample splash the window) | No | No | No | No |
j Sample Storage study
To study the effects of different sample storage conditions at 2-8°C for 0h / 48h and at room temperature (10-30°C ) for 0h / 12h on performance of tests. Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/mL HCG (negative samples) and 25 mIU/mL HCG (positive samples were separated in two parts, one part was stored at 2-8°C for 0h and 48h while another part was stored at room temperature (10-30°C) for 0h and 12h. All samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes after sample addition. The results summarized in Table 16 indicated that the test results all met criteria acceptance when urine sample stored at 10-30℃ for 12 hours and 2-8℃ for 48 hours.
| Sample | 2-8°C | 10-30°C | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0h | 48h | 0h | 12h | |||||||||||
| Strip | Midstream | Strip | Midstream | Strip | Midstream | Strip | Midstream | |||||||
| + | - | + | - | + | - | + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
Table 16 Sample Storage results of the tests
k Sample container material study
To evaluate the effect of tests samples stored in different sample container material (paper cups (coated), paper cups (uncoated), plastic urine cups and glass cups) on performance at 2-8°C for 48h and at room temperature (10-30°C) for 12h. Urine samples from non-pregnant females (negative samples) were spiked with 0 mIU/ml HCG (negative samples) and 25 mIU/mL HCG (positive samples were separated in two parts, one part of samples was stored at 2-8°C for 48h while another part was stored at room temperature (10-30°C) for 12h, both part of samples was stored using paper cups (coated), paper cups (uncoated), plastic urine cups, and glasses in two
13
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhina temperature storage conditions. For each condition, all samples were tested in 5 replicates by 1 lot of each format of the device and then read the results at 3 minutes after sample addition. The results summarized in Table 17 to Table 20 indicated that no sample container material effect was observed when tested with up to a concentration of 0mIU/mL and 25mIU/mL of human chorionic gonadotropin with the test.
| Storage Material | Paper cups(coated) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | 2-8°C | 10-30°C | ||||||
| 48h | 12h | |||||||
| Strip | Midstream | Strip | Midstream | |||||
| + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
| Table 18 Sample container material results of the tests | ||||||||
| Storage Material | Paper cups(no coated) | |||||||
| Sample | 2-8°C | 10-30°C | ||||||
| 48h | 12h | |||||||
| Strip | Midstream | Strip | Midstream | |||||
| + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
Table 17 Sample container material results of the tests
Table 19 Sample container material results of the tests
| Storage Material | Plastic urine cups | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2-8°C | 10-30°C | ||||||||
| 48h | 12h | ||||||||
| Sample | Strip | Midstream | Strip | Midstream | |||||
| + | - | + | - | + | - | + | - | ||
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
Table 20 Sample container material results of the tests
| Storage Material | Glasses | |||||||
|---|---|---|---|---|---|---|---|---|
| 2-8°C | 10-30°C | |||||||
| 48h | 12h | |||||||
| Sample | Strip | Midstream | Strip | Midstream | ||||
| + | - | + | - | + | - | + | - | |
| 0mIU/mL HCG | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
| 25mIU/mL HCG | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
9.2 Comparison Studies
a Method comparison with predicate device
The performance of the two device formats (Strip, midstream ) of the test was compared to the predicate device. Testing was performed by laboratory professionals at three point-of care (POC) sites with urine samples from 330 women between the age of 18-45, Urine samples were collected from 330 women presenting to test for pregnancy. Approximately half of the 330 women were suspected to be pregnant. All samples were tested with candidate and predicate devices at three POC sites,each format of device was tested in 3 sites( 3 different professionals using the
14
candidate device and the predicate device at each site, totally 9 different professionals conducted the study ). The results are summarized in Table 21 - Table 23 below.
| Candidate Device | Predicate Device | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Strip Format | Positive | 58 | 0 | 58 |
| Strip Format | Negative | 0 | 52 | 52 |
| Total | 58 | 52 | 110 |
Table 21 Test Strip Format method comparison results
Sensitivity:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Specificity:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Accuracy:100.00% (110/110), Wilson 95%Cl:96.63%-100.00%.
Positive predictive value:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Negative predictive value:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Table 22 Test Midstream Format Immersion sample method comparison results
| Predicate Device | ||||
|---|---|---|---|---|
| Candidate Device | Positive | Negative | Total | |
| Midstream (Immersion sample) | Positive | 59 | 0 | 59 |
| Negative | 0 | 52 | 52 | |
| Total | 59 | 52 | 111 |
Sensitivity:100.00% (59/59), Wilson 95%Cl:93.89%-100.00%.
Specificity:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Accuracy:100.00% (111/111), Wilson 95%Cl:96.65%-100.00%.
Positive predictive value:100.00% (59/59), Wilson 95%Cl:93.89%-100.00%.
Negative predictive value:100.00% (52/52), Wilson 95%Cl:93.12%-100.00%.
Table 23 Test Midstream Format Urinate sample method comparison results
| Candidate Device | Predicate Device | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Midstream (Urinate sample) | Positive | 58 | 0 | 58 |
| Negative | 0 | 51 | 51 | |
| Total | 58 | 51 | 109 |
Sensitivity:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Specificity:100.00% (51/51), Wilson 95%Cl:93.00%-100.00%.
Accuracy:100.00% (109/109), Wilson 95%Cl:96.60%-100.00%.
Positive predictive value:100.00% (58/58), Wilson 95%Cl:93.79%-100.00%.
Negative predictive value:100.00% (51/51), Wilson 95%Cl:93.00%-100.00%.
The data shows that the agreement of the tests with the predicate device was 100%.
b Matrix comparison
Not applicable. This device is for testing with human urine only.
10 Clinical studies
Clinical Sensitivity a
Not applicable
15
b Clinical specificity
Not applicable
Other clinical supportive data (when a. and b. are not applicable) C
Lay-User Study c. 1
A lay user study was conducted at 3 sites with 330 volunteers with diverse educational and occupational backgrounds who were between the ages of 18 and 45. This included 110 lay-users using the HCG One Step Pregnancy Test Strip OTC, 220 lay-users using the HCG one step Pregnancy Test Midstream OTC, split between 111 users performing Immersion sample and 109 users performing Urinate sample. The lay users tested their own urine sample and provided a sample for professional testing. Ease of use of the candidate devices was assessed through a questionnaire that was completed at the end of the study. The questionnaire results indicated that lay-users found the tests easy to use, the results clear and easy to read and the instructions for use easy to understand. The data shows that the agreement between lay-user results and professional results was 100% in Table 26 below.
| Strip Format | Professional test results | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Lay user test | ||||
| results | Positive | 58 | 0 | 58 |
| Negative | 0 | 52 | 52 | |
| Total | 58 | 52 | 110 |
Table 24 Lay user and professional test results for Strip OTC
Positive coincidence rate=100%×58/ (58+0)=100.00%,Wilson 95%Cl:93.79%-100.00%. Negative coincidence rate=100%×52/ (0+52)=100.00%,Wilson 95%Cl:93.12%-100.00%. Total coincidence rate=100%×(58+52)/ (58+0+0+52)=100.00%,Wilson 95%Cl:96.63%-100.00%.
Table 25 Lay user and professional test results for Midstream OTC (Immersion sample)
| Midstream | Professional test results | Total | ||
|---|---|---|---|---|
| (Immersion sample) | Positive | |||
| Negative | ||||
| Lay user test | Positive | ਵਿੱਚ | 0 | ਵਿੱਚ ਸੀ। ਇਹ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਇੱ |
| results | Negative | 0 | 52 | 52 |
| Total | ਵਿੱਚ | 52 | 111 |
Positive coincidence rate=100%×59/ (59+0)=100.00%,Wilson 95%Cl:93.89%-100.00%.
Negative coincidence rate=100%×52/ (0+52)=100.00%,Wilson 95%Cl:93.12%-100.00%.
Total coincidence rate=100%×(59+52)/ (59+0+0+52)=100.00%,Wilson 95%Cl:96.65%-100.00%.
Table 26 Lay user and professional test results for Midstream OTC (Urinate sample)
| Midstream
| (Urinate sample) | Professional test results | Total | ||
|---|---|---|---|---|
| Lay user test | ||||
| results | Positive | Negative | ||
| Positive | 58 | 0 | 58 | |
| Negative | 0 | 51 | 51 | |
| Total | 58 | 51 | 109 |
Positive coincidence rate=100%×58/ (58+0)=100.00%,Wilson 95%Cl:93.79%-100.00%.
Negative coincidence rate=100%×51/ (0+51)=100.00%,Wilson 95%Cl:93.00%-100.00%.
Total coincidence rate=100%×(58+51)/ (58+0+0+51)=100.00%,Wilson 95%Cl:96.60%-100.00%.
A Flesch-Kincaid reading analysis is performed on each package insert for the OTC devices and the score of the tests demonstrates a reading Grade Level of 7, the results show that the labels can be understood by people with no more than 7th grade education.
16
d Clinical Cut-off
Not applicable
11 Conclusion
Based on the test principle and performance characteristics of the device including precision, sensitivity, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that the tests are substantially equivalent to the predicate.
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.