(193 days)
Not Found
No
The device description and performance studies focus on a traditional immunoassay for detecting HCG. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is a diagnostic test used to detect pregnancy, not to treat it.
Yes
The device qualitatively detects human chorionic gonadotropin in urine to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device description explicitly states that the device is in three different formats: Strip, Cassette, and Midstream, and includes physical components like test pens/strips/cassettes, medical waste bags, urine cups, and droppers. These are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy." This involves testing a sample (urine) taken from the human body in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Device Description: The description confirms it's a test device that analyzes a urine sample.
- Performance Studies: The performance studies involve testing urine samples and comparing the results to a predicate device, which is typical for IVD validation.
- Predicate Device: The mention of predicate devices (other pregnancy rapid tests) further indicates that this device falls within the category of IVDs.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Product codes
LCX
Device Description
Synthgene Home Test HCG Test is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains the individually packaged test pen/strip/cassette, medical waste bag, urine cup and instructions for Use. The cassette format also contains a dropper. The device is in a readyto-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
18 and 49 years old
Intended User / Care Setting
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
Urine samples were collected from 333 women aged 18 - 49 who presented for pregnancy testing at 3 sites. Samples were randomly collected at various times throughout the day and blinded before being tested by professionals using the candidate devices and the predicate device. A total of 121 samples tested with the Synthgene Home Test HCG Test Midstream, 109 samples tested with the Synthgene Home Test HCG Test Cassette, and 103 samples tested with the Synthgene Home Test HCG Test Strip. Of the 121 samples tested using the midstream format, 61 were tested in dip sampling mode and 60 were tested in midstream sampling mode.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
Precision/Reproducibility/Sensitivity: Negative urine collected from females was spiked with hCG standard to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. The spiked samples were measured using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 10 runs per day per lot for 5 days. For each format of the device, a total of 450 replicates were tested for each HCG concentration. Based on the test results, the sensitivity of Synthgene Home Test HCG Test is demonstrated to be 25 mIU/mL. There were no significant differences in performance between lots, between operators, between sites, between time of day and between days.
Method comparison study:
Urine samples were collected from 333 women aged 18 - 49 who presented for pregnancy testing at 3 sites. Samples were randomly collected at various times throughout the day and blinded before being tested by professionals using the candidate devices and the predicate device. A total of 121 samples tested with the Synthgene Home Test HCG Test Midstream, 109 samples tested with the Synthgene Home Test HCG Test Cassette, and 103 samples tested with the Synthgene Home Test HCG Test Strip.
Lay-User Study:
A lay user study was conducted at three sites with female subjects who were able to adequately understand and use the instructions for use to conduct testing. These subjects had diverse educational and professional backgrounds and their age range was between 18 and 49 years old. A total of 333 subjects participated in the study, included 121 lay-users using the Synthgene Home Test HCG Test Midstream, 109 lay-users using the Synthgene Home Test HCG Test Cassette, and 103 lay-users using the Synthgene Home Test HCG Test Strip.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/mL (for each format). At 25 mIU/mL and above, the test showed 100% positive results.
At 22.5 mIU/mL, the positive rates varied slightly by format: Strip (87.3%), Midstream (84.9%), Cassette (86.2%), and Strip (85.11%).
At 0, 12.5, and 18.75 mIU/mL, the test showed 0% positive results and 100% negative results across all formats.
Method Comparison Results for Midstream Format (Dip application method):
Synthgene Home Test HCG Test Midstream Positive: 38 (compared to predicate Positive)
Synthgene Home Test HCG Test Midstream Negative: 23 (compared to predicate Negative)
Total: 61
Method Comparison Results for Midstream Format (Midstream application method):
Synthgene Home Test HCG Test Midstream Positive: 40 (compared to predicate Positive)
Synthgene Home Test HCG Test Midstream Negative: 20 (compared to predicate Negative)
Total: 60
Method Comparison Results for Cassette Format:
Synthgene Home Test HCG Test Cassette Positive: 60 (compared to predicate Positive)
Synthgene Home Test HCG Test Cassette Negative: 49 (compared to predicate Negative)
Total: 109
Method Comparison Results for Strip Format:
Synthgene Home Test HCG Test Strip Positive: 54 (compared to predicate Positive)
Synthgene Home Test HCG Test Strip Negative: 49 (compared to predicate Negative)
Total: 103
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 31, 2025
Nanjing Synthgene Medical Technology Co., Ltd. Alvin Oian Registration Manager Building B6-2, No. 9, Weidi Road, Xianlin University Town Xianlin Subdistrict, Qixia District Nanjing, Jiangsu 210000 China
Re: K242135
Trade/Device Name: Synthgene Home Test HCG Test Strip: Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG 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 20, 2024 Received: December 20, 2024
Dear Alvin Qian:
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
1
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).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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
2
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,
Joseph A.
Kotarek -S
Digitally signed by
Joseph A. Kotarek -S
Date: 2025.01.31 08:35:49
-05'00'
Joseph Kotarek, Phd.D.
Branch Chief
Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
Indications for Use (Describe)
Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
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
K242135
1. Date Prepared
January 24, 2025
2. Submitter
Company Name: Nanjing Synthgene Medical Technology Co., Ltd.
Address: Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin
Subdistrict, Qixia District, Nanjing City, Nanjing, Jiangsu, 210000, CHINA
Establishment Registration Number: 3016902172
Contact Person: ALVIN QIAN
Position: Registration Manager
Tel.: +86 15755073877
E-mail: alvin(@syngenebio.com
3. Proposed Device
Trade Name of Device: Synthgene Home Test HCG Test Strip
Synthgene Home Test HCG Test Cassette
Synthgene Home Test HCG Test Midstream
Classification Name: Kit, Test, Pregnancy, Hcg, Over The Counter
Classification: II
Product Code: LCX
Regulation Number: 21 CFR 862.1155
Review Panel: Clinical Chemistry
4. Predicate Devices
510(k) Number: K192123
Trade/Product Name: HIGHTOP Pregnancy Rapid Test Cassette
5
510(k) summary HIGHTOP Pregnancy Rapid Test Strip
HIGHTOP Pregnancy Rapid Test Midstream
Regulation Name: Human chorionic gonadotropin (HCG) test system Classification name: kit, test, pregnancy, hcg, over the counter Regulation Number: 21 CFR 862.1155 Device Class: Class II Product Code: LCX Manufacturer: Qingdao Hightop Biotech Co., Ltd.
5. Device description
Synthgene Home Test HCG Test is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains the individually packaged test pen/strip/cassette, medical waste bag, urine cup and instructions for Use. The cassette format also contains a dropper. The device is in a readyto-use format and does not require assembly before use.
6. Indication for use
Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthgene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthgene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
7. Comparison of technological characteristics with the predicate devices
The comparison and discussion between the candidate device and the predicate devices are listed in table below.
Table 1 Comparison of Candidate Devices with the Predicate Devices
6
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device (K192123) |
| Product name | Synthgene Home Test HCG Test Strip | |
| Synthgene Home Test HCG Test Cassette | ||
| Synthgene Home Test HCG Test Midstream | HIGHTOP Pregnancy Rapid Test Cassette | |
| HIGHTOP Pregnancy Rapid Test Strip | ||
| HIGHTOP Pregnancy Rapid Test Midstream | ||
| Intended Use | Early detection of pregnancy. | Same |
| Specimen Type | Urine | Same |
| Assay methodology | Immunochromatographic assay | Same |
| Sensitivity | 25 mIU/mL | Same |
| Results | Qualitative | Same |
| Intended user | Over the counter use | Same |
| Device format | Strip/Cassette/Midstream | Same |
| Differences | ||
| Reading Time | 5-20 minutes | 5 minutes |
8. Test Principle
The product adopts the principle of double antibody sandwich. When human chorionic gonadotropin is present in the sample, the HCG antigen in the sample reacts with the colloidal gold-labeled antibody (HCG mAb1) on the conjugate pad to form the labeled antibody-antigen complex. The complex is chromatographed upward by capillary action and captured by the detection line (T line) antibody (HCG mAb2) coated on the nitrocellulose membrane, appearing as a red band. The complex continues to move chromatographically upward, and is captured by the control line (C line) antibody (goat anti-mouse IgG polyclonal antibody) coated on the nitrocellulose membrane, and a red band appears. When the concentration of HCG in the sample is lower than the sensitivity, the detection line (T line) does not develop color.
9. Performance Characteristics
7
9.1 Analytical performance
Precision/Reproducibility/Sensitivity a
Negative urine collected from females was spiked with hCG standard to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. The spiked samples were measured using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 10 runs per day per lot for 5 days. For each format of the device, a total of 450 replicates were tested for each HCG concentration. Based on the test results, the sensitivity of Synthgene Home Test HCG Test is demonstrated to be 25 mIU/mL. There were no significant differences in performance between lots, between operators, between sites, between time of day and between days. The results are summarized in the table below:
| Dip method | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | |||||||||||
| No. | HCG | ||||||||||
| concentration | |||||||||||
| (mIU/mL) | Lot 1 | Lot 2 | Lot 3 | Total | |||||||
| results | Pos | Neg | |||||||||
| - | + | - | + | - | + | - | + | ||||
| S1 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S2 | 12.5 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S3 | 18.75 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S4 | 22.5 | 20 | 130 | 20 | 130 | 17 | 133 | 57 | 393 | 87.3% | 12.7% |
| S5 | 25 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S6 | 50 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S7 | 100 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S8 | 200 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
Midstream Format
Midstream method
| Sample
No. | HCG
concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
results | | Pos | Neg |
|---------------|----------------------------------|-------|-----|-------|-----|-------|-----|------------------|-----|-------|-------|
| | | - | + | - | + | - | + | - | + | | |
| S1 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S2 | 12.5 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S3 | 18.75 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S4 | 22.5 | 23 | 127 | 24 | 126 | 21 | 129 | 68 | 382 | 84.9% | 15.1% |
| S5 | 25 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S6 | 50 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S7 | 100 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S8 | 200 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
8
Cassette Format
| Sample
No. | HCG
concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
results | | Pos | Neg |
|---------------|----------------------------------|-------|-----|-------|-----|-------|-----|------------------|-----|-------|-------|
| | | - | + | - | + | - | + | - | + | | |
| S1 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S2 | 12.5 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S3 | 18.75 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S4 | 22.5 | 19 | 131 | 24 | 126 | 19 | 131 | 62 | 388 | 86.2% | 13.8% |
| S5 | 25 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S6 | 50 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S7 | 100 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S8 | 200 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
Strip Format
| Sample
No. | HCG
concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
results | | Pos | Neg |
|---------------|----------------------------------|-------|-----|-------|-----|-------|-----|------------------|-----|--------|--------|
| | | - | + | - | + | - | + | - | + | | |
| S1 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S2 | 12.5 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S3 | 18.75 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 0 | 0% | 100% |
| S4 | 22.5 | 23 | 127 | 23 | 127 | 21 | 129 | 67 | 383 | 85.11% | 14.89% |
| S5 | 25 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S6 | 50 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S7 | 100 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
| S8 | 200 | 0 | 150 | 0 | 150 | 0 | 150 | 0 | 450 | 100% | 0% |
Linearity/assay reportable range: b
Linearity is not applicable since this is a qualitative test.
Traceability, Stability, Expected values (controls, calibrators, or methods) Synthgene Home Test HCG Test is calibrated against reference material traceable to WHO International Standard 6th edition (NIBSC code: 18/244).
A shelf-life stability test of the devices was performed by Real-time Stability Study. The results showed that the devices were stable for 24 months when stored at 2~30℃ in the sealed foil pouch.
Cross reactivity C
To evaluate specificity and cross-reactivity, negative and positive urine samples (0
9
mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2,000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
d Interfering substance
A study was performed to evaluate the potential for interference by certain exogenous and endogenous compounds. Each substance was prepared by diluting stock interference material to the desired concentration. Urine specimens containing 0 and 25 mIU/ml HCG were spiked with the potential interferents to obtain the desired test concentration. The results show that no interferences were observed from substance at the following concentrations for both negative and positive urine samples.
| Interfering substance | Substances concentration |
|---|---|
| Acetaminophen | 0.2 mg/mL |
| Aspirin | 0.2 mg/mL |
| Vitamin C | 0.2 mg/mL |
| Atropine | 0.2 mg/mL |
| Ampicillin | 0.2 mg/mL |
| Tetracycline | 0.2 mg/mL |
| 2,5-Dihydroxybenzoic acid | 0.2 mg/mL |
| Caffeine | 0.2 mg/mL |
| Phenothiazine | 0.2 mg/mL |
| Ethanol | 1% |
| Human Albumin | 20 mg/mL |
| Triglyceride | 8 mg/mL |
| Hemoglobin | 5 mg/mL |
| Bilirubin | 0.02 mg/mL |
| Glucose | 20 mg/mL |
| Acetoacetic Acid | 20 mg/mL |
| Asorbic Acid | 0.2 mg/mL |
| B-hydroxybutyrate | 20 mg/mL |
| Ephedrine | 0.2 mg/mL |
| Gentisic Acid | 0.2 mg/mL |
| Phenylpropanolamine | 0.2 mg/mL |
| Salicylic Acid | 0.2 mg/mL |
| EDTA | 0.8 mg/mL |
| Benzoylecgonine | 0.1 mg/mL |
| Cannabinol | 0.1 mg/mL |
| Codeine | 0.06 µg/mL |
| Methanol | 10% |
| Estriol-17-beta | 14 mg/mL |
| Pregnanediol | 15 µg/mL |
| Thiophene | 0.2 mg/mL |
| Ketone | 0.2 mg/mL |
Effects of Urine pH e
10
To evaluate potential interference from changes in pH, urine samples containing 0 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4 - 9 do not interfere in the results that were either positive or negative for hCG.
f Effects of Specific Gravity
To evaluate potential interference from changes in specific gravity, urine samples containing 0 mIU/mL and 25 mIU/mL hCG were tested at specific gravity values at 1.000, 1.002, 1.009, 1.012, 1.018, 1.028, 1.032 and 1.035. The results demonstrated that urine samples with a specific gravity between 1.000-1.035 do not interfere in the results that were either positive or negative for hCG.
Hook effect test g
Negative urine samples were spiked with varying hCG concentrations (2325, 4650, 9300, 11,625, 58,125, 116,250, 232,500, 465,000, 930,000 and 1,860,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 2325 to 1,860,000 mIU/ml.
9.2 Method comparison study
Method comparison with predicate device a
Urine samples were collected from 333 women aged 18 - 49 who presented for pregnancy testing at 3 sites. Samples were randomly collected at various times throughout the day and blinded before being tested by professionals using the candidate devices and the predicate device. A total of 121 samples tested with the Synthgene Home Test HCG Test Midstream, 109 samples tested with the Synthgene Home Test HCG Test Cassette, and 103 samples tested with the Synthgene Home Test HCG Test Strip. Of the 121 samples tested using the midstream format, 61 were tested in dip sampling mode and 60 were tested in midstream sampling mode. The results of the study are summarized in the tables below:
| Midstream Format - Dip application method: | |
|---|---|
| -------------------------------------------- | -- |
| Synthgene Home Test | HIGHTOP Pregnancy Rapid Test
Midstream | Total |
| --------------------- | ------------------------------------------- | ------- |
|---|
11
| HCG Test Midstream | Positive | Negative | |
|---|---|---|---|
| Positive | 38 | 0 | 38 |
| Negative | 0 | 23 | 23 |
| Total | 38 | 23 | 61 |
Midstream Format - Midstream application method :
| Synthgene Home Test
HCG Test Midstream | HIGHTOP Pregnancy Rapid Test
Midstream | | Total |
|-------------------------------------------|-------------------------------------------|----------|-------|
| | Positive | Negative | |
| Positive | 40 | 0 | 40 |
| Negative | 0 | 20 | 20 |
| Total | 40 | 20 | 60 |
For Synthgene Home Test HCG Test Cassette
| Synthgene Home Test HCG Test
Cassette | HIGHTOP Pregnancy Rapid Test
Cassette | | Total |
|------------------------------------------|------------------------------------------|----------|-------|
| | Positive | Negative | |
| Positive | 60 | 0 | 60 |
| Negative | 0 | 49 | 49 |
| Total | 60 | 49 | 109 |
For Synthgene Home Test HCG Test Strip
| Synthgene Home Test
| HCG Test Strip | HIGHTOP Pregnancy Rapid Test Strip | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive | 54 | 0 | 54 |
| Negative | 0 | 49 | 49 |
| Total | 54 | 49 | 103 |
b Matrix comparison
Not applicable. The device is for use with urine samples only.
9.3 Clinical studies
Clinical Sensitivity a
Not applicable.
Clinical specificity b
Not applicable.
12
Other clinical supportive data (when a. and b. are not applicable): C
Lay-User Study
A lay user study was conducted at three sites with female subjects who were able to adequately understand and use the instructions for use to conduct testing. These subjects had diverse educational and professional backgrounds and their age range was between 18 and 49 years old. A total of 333 subjects participated in the study, included 121 layusers using the Synthgene Home Test HCG Test Midstream, 109 lay-users using the Synthgene Home Test HCG Test Cassette, and 103 lay-users using the Synthgene Home Test HCG Test Strip.
The test results are summarized below:
| Synthgene Home Test
HCG Test Midstream | HIGHTOP Pregnancy Rapid Test
Midstream | | Total |
|-------------------------------------------|-------------------------------------------|----------|-------|
| | Positive | Negative | |
| Positive | 38 | 0 | 38 |
| Negative | 0 | 23 | 23 |
| Total | 38 | 23 | 61 |
Midstream Format - Dip application method
Midstream Format - Midstream application method:
| Synthgene Home Test
HCG Test Midstream | HIGHTOP Pregnancy Rapid Test
Midstream | | Total |
|-------------------------------------------|-------------------------------------------|----------|-------|
| | Positive | Negative | |
| Positive | 40 | 0 | 40 |
| Negative | 0 | 20 | 20 |
| Total | 40 | 20 | 60 |
For Synthgene Home Test HCG Test Cassette
| Synthgene Home Test HCG Test
Cassette | HIGHTOP Pregnancy Rapid Test
Cassette | | Total |
|------------------------------------------|------------------------------------------|----------|-------|
| | Positive | Negative | |
| Positive | 60 | 0 | 60 |
| Negative | 0 | 49 | 49 |
| Total | 60 | 49 | 109 |
For Synthgene Home Test HCG Test Strip
| Synthgene Home Test
| HCG Test Strip | HIGHTOP Pregnancy Rapid Test Strip | Total | |
|---|---|---|---|
| Positive | Negative |
13
| Positive | 54 | 0 | 54 |
|---|---|---|---|
| Negative | 0 | 49 | 49 |
| Total | 54 | 49 | 103 |
Each lay user 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.
Clinical cut-off: d
Not applicable
Expected values/Reference range: e
Not applicable.
10. Conclusion
Based on the test principle and acceptable performance characteristics including precision, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the Synthgene Home Test HCG Test Strip, Synthgene Home Test HCG Test Cassette, and Synthgene Home Test HCG Test Midstream are substantially equivalent to the predicate.