(53 days)
Not Found
No
The device description and performance studies focus on chemical detection of HCG and do not mention any computational analysis or algorithms, let alone AI/ML.
No
This device is a diagnostic tool used to detect the presence of HCG in urine, aiding in the early detection of pregnancy. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy." This directly indicates its use for diagnosing a condition (pregnancy) based on a biomarker.
No
The device description clearly states it is a physical test strip or midstream device with an absorbent tip and plastic housing, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Device Description: The device is designed to analyze a biological sample (urine) to provide a result related to a physiological state.
- Performance Studies: The document details various performance studies conducted on urine samples (analytical performance, specificity, cross-reactivity, interfering substances, method comparison, lay person studies using urine). These are typical studies performed for IVD devices to demonstrate their accuracy and reliability in testing biological samples.
- Predicate Device: The mention of a "Predicate Device" with a K number (K043443; One Step HCG Urine Pregnancy Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and 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
Home environment. 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)
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. Each sample was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested. Tests were performed by three different operators for each sample concentration.
Key results: MissLan® Pregnancy Rapid Test exhibited reproducibility of results. Based on the above results, the sensitivity of MissLan® Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
**b. Linearity/assay reportable range:**
*Hook effect test:* Negative urine samples were spiked with varying hCG concentrations (6.250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL).
*Key results:* All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.
**c. Traceability, Stability, Expected values (controls, calibrators, or methods):**
*Traceability:* MissLan® Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
*Stability:* A 32-month real time stability test is planned to verify the shelf-life stability of the device. Three batches for each format in sealed foil pouch are currently stable for 30 months at 2°C and 30°C, and the real time stability study is still on going.
**d. Specificity and cross reactivity**
*Specificity:* 450 urine samples were collected from normal, nonpregnant female in pre-menopausal (ages 18~40 years old), peri-menopausal (41~55 years old) and post-menopausal (>55 years old) groups. 150 people for each age group. In each age group, 50 participants were tested with test strip, 50 participants were tested with test midstream using dip method, and 50 participants tested with test midstream using in-stream method.
*Key results:* No false positive results were observed for any of the age groups.
*Cross-reactivity:* Negative and positive urine samples (0, 5 and 25 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH).
*Key results:* No cross-reactivity was observed at tested concentration.
*hCG ß-core fragment effect:* Negative urine samples (0 and 5 mIU/mL hCG) and positive urine samples (25 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L.
*Key results:* The performance of MissLan® Pregnancy Rapid Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
**e. Interfering substance**
*Interferers:* Urine samples containing 0, 5 and 25 mIU/mL hCG were spiked with various interfering substances.
*Key results:* No interference effect was observed at the tested concentrations for the listed substances (Glucose, Albumin, Bilirubin, Hemoglobin, Uric acid, Acetaminophen, Amoxicillin, Aspirin, Gentisic acid, Salicylic Acid, Ascorbic acid, Folic acid, Vitamin B1, Atropine, Caffeine, Tetracycline, Ampicillin, Ibuprofen, Pregnanediol, β-hydroxybutyrate, EDTA, Ethanol, Ketone, Thiophene, Benzoylecgonine, Cannabinol, Ephedrine, Phenylpropanolamine, Phenothiazine).
*Urine pH effect:* Urine samples containing 0, 5 and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9.
*Key results:* The results indicated that urine pH ranges between 4 and 9 does not affect the performance of MissLan® Pregnancy Rapid Test.
*Urine density effect:* Urine samples containing 0, 5 and 25 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035.
*Key results:* The results indicated that urine with a relative density of 1.035 does not affect the performance of MissLan® Pregnancy Rapid Test.
B. Method comparison study
Study type: Comparison with predicate device.
Sample size: Urine samples were collected from 200 women (approximately half suspected to be pregnant, mostly in early stage
§ 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). 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.
February 28, 2023
Guangzhou Decheng Biotechnology Co., Ltd. % Joe Shia, Director LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K230038
Trade/Device Name: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 5, 2023 Received: January 6, 2023
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Paula Paula Caposino - Caposino -S Caposino -S
Caposino -S Date: 2023.02.28
17:36:04 -05:00 - 17:36:04 -05:00 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
Enclosure
2
Indications for Use
510(k) Number (if known) K230038
Device Name MissLan® Pregnancy Rapid Test (Strip) MissLan® Pregnancy Rapid Test (Midstream)
Indications for Use (Describe)
MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
K230038
| 1. | Date: | February 26, 2023 |
|---|---|---|
| 2. | Submitter: | Guangzhou Decheng Biotechnology Co., Ltd. |
| Building 2, No.68, Nanxiang 1st Road, Science | ||
| City, Huangpu District, Guangzhou, Guangdong, | ||
| 510000, China | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite I | ||
| Gaithersburg, MD 20877 | ||
| Telephone: 240-505-7880 | ||
| Fax: 301-916-6213 | ||
| Email: shiajl@yahoo.com | ||
| 4. | Device Name: | MissLan® Pregnancy Rapid Test (Strip) |
| MissLan® Pregnancy Rapid Test (Midstream) | ||
| Classification: | Class II | |
| Product Code: | LCX | |
| CFR: | 862.1155 | |
| 5. | Predicate Devices: | One Step HCG Urine Pregnancy Test |
| (K043443) |
6. Intended Use
MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
7. Device Description
4
MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
| Intended use | Early detection of | |
| pregnancy | Early detection of | |
| pregnancy | ||
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic | |
| assay | Immunochromatographic | |
| assay | ||
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Read time | 3-5 minutes | 3-5 minutes |
| Differences | ||
| Item | Device | Predicate |
| Device format | Midstream, Strip | Midstream, Strip, Cassette |
| Target user | Over the counter use | For over-the-counter and |
| professional use |
8. Substantial Equivalence Information
9. Test Principle
MissLan® Pregnancy Rapid Test uses lateral flow immunoassay for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. If hCG is present in the sample, it will reach the Test Zone ("T") of the membrane and form a colored line. When the test is performed properly, a colored line will always appear in the Control Zone ("C"). The test result is shown in the result window and read visually between 3 and 5 minutes of urine application. Two distinct colored lines, one in the Test Zone and another in the Control Zone indicate a positive test result (pregnant). Absence of a colored line in the Test Zone and only a colored line in the Control Zone indicates a negative test result (not pregnant). Absence of a colored line in the Control Zone even in the presence of a colored line in the Test Zone indicates an invalid test result.
10. Performance Characteristics
5
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. Each sample was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested. Tests were performed by three different operators for each sample concentration. The results are summarized in the table below:
| hCG
Concentration
(mIU/mL) | Operator 1
Lot 1 | | Operator 2
Lot 2 | | Operator 3
Lot 3 | | Total
result | | % | |
|----------------------------------|---------------------|----|---------------------|----|---------------------|----|-----------------|-----|----------|----------|
| | - | + | - | + | - | + | - | + | Negative | Positive |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 25 | 25 | 26 | 24 | 23 | 27 | 74 | 76 | 49.3% | 50.7% |
| 18.75 | 12 | 38 | 13 | 37 | 12 | 38 | 37 | 113 | 24.7% | 75.3% |
| 22.5 | 5 | 45 | 4 | 46 | 4 | 46 | 13 | 137 | 8.7% | 91.3% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
Midstream format (in-stream method)
Midstream format (dip method)
| hCG
Concentration
(mIU/mL) | Operator
1
Lot 1 | | Operator
2
Lot 2 | | Operator
3
Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|------------------------|----|------------------------|----|------------------------|----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 25 | 25 | 27 | 23 | 24 | 26 | 76 | 74 | 50.7% | 49.3% |
| 18.75 | 12 | 38 | 13 | 37 | 13 | 37 | 38 | 112 | 25.3% | 74.7% |
| 22.5 | 5 | 45 | 5 | 45 | 4 | 46 | 14 | 136 | 9.3% | 90.7% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
Strip format
| hCG
Concentration | Operator
1 | Operator
2 | Operator
3 | Total
result | %
Negative | %
Positive |
| ---------------------- | --------------- | --------------- | --------------- | ----------------- | --------------- | --------------- |
|---|
6
| (mIU/mL) | Lot 1 | Lot 2 | Lot 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 25 | 25 | 24 | 26 | 24 | 26 | 73 | 77 | 48.7% | 51.3% |
| 18.75 | 11 | 39 | 12 | 38 | 13 | 37 | 36 | 114 | 24.0% | 76.0% |
| 22.5 | 5 | 45 | 4 | 46 | 5 | 45 | 14 | 136 | 9.3% | 90.7% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
MissLan® Pregnancy Rapid Test exhibited reproducibility of results.
Based on the above results, the sensitivity of MissLan® Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
b. Linearity/assav reportable range:
Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.
Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (6.250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
MissLan® Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
Stability:
A 32-month real time stability test is planned to verify the shelf-life stability of the device. Three batches for each format in sealed foil pouch are currently stable for 30 months at 2°C and 30°C, and the real time stability study is still on going.
d. Specificity and cross reactivity
To evaluate specificity, 450 urine samples were collected from normal, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 150 people for each age group. In each age group, 50 participants were tested with test strip, 50 participants were tested with test midstream using dip method, and 50 participants
7
tested with test midstream using in-stream method. No false positive results were observed for any of the age groups.
To evaluate cross-reactivity, negative and positive urine samples (0, 5 and 25 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). No cross-reactivity was observed at tested concentration.
To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 5 mIU/mL hCG) and positive urine samples (25 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. The performance of MissLan® Pregnancy Rapid Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
e. Interfering substance
To evaluate potential interferers with MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:
| Substance | Concentration |
|---|---|
| Glucose | 2000 mg/dL |
| Albumin | 2000 mg/dL |
| Bilirubin | 40 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Uric acid | 23.5 mg/dL |
| Acetaminophen | 20 mg/dL |
| Amoxicillin | 20 mg/dL |
| Aspirin | 80 mg/dL |
| Gentisic acid | 20 mg/dL |
| Salicylic Acid | 20 mg/dL |
| Ascorbic acid | 20 mg/dL |
| Folic acid | 0.03 mg/dL |
| Vitamin B1 | 80 mg/dL |
| Atropine | 20 mg/dL |
| Caffeine | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Ibuprofen | 40 mg/dL |
| Pregnanediol | 1.5 mg/dL |
| β-hydroxybutyrate | 2000 mg/dL |
8
| EDTA | 80 mg/dL |
|---|---|
| Ethanol | 1% |
| Ketone | 20 mg/dL |
| Thiophene | 20 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Cannabinol | 10 mg/dL |
| Ephedrine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
To evaluate the effect of urine pH on the results of MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of MissLan® Pregnancy Rapid Test.
To evaluate the effect of urine density on the results of MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that urine with a relative density of 1.035 does not affect the performance of MissLan® Pregnancy Rapid Test.
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 200 women presenting to test for pregnancy. Approximately half of the 200 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site). The same samples were tested on both format by different operators.
The results are summarized in the table below.
| Predicate device | ||||
|---|---|---|---|---|
| Candidate device | Positive | Negative | Total | |
| Strip Device | Positive | 101 | 0 | 101 |
| Negative | 0 | 99 | 99 | |
| Total | 101 | 99 | 200 |
| Predicate device | |||
|---|---|---|---|
| Candidate device | Positive | Negative | Total |
| Midstream Device | 52 | 0 | 52 |
| In-stream method | 0 | 48 | 48 |
9
| Total | 52 | 48 | 100 | |
|---|---|---|---|---|
| Predicate device | ||||
| Candidate device | Positive | Negative | Total | |
| Midstream Device | ||||
| Dip method | Positive | 49 | 0 | 49 |
| Negative | 0 | 51 | 51 | |
| Total | 49 | 51 | 100 |
The conformity between MissLan® Pregnancy Rapid Test and the predicate device is 100%.
C. Lay person study
First study:
200 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
The results are summarized in the table below.
Strip Device
| Strip format | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 52 | 0 | 52 |
| Negative | 0 | 48 | 48 | |
| Total | 52 | 48 | 100 |
Midstream Device
| Professional | ||||
|---|---|---|---|---|
| Midstream format | ||||
| (in-stream method) | Positive | Negative | Total | |
| Layperson | Positive | 26 | 0 | 26 |
| Negative | 0 | 24 | 24 | |
| Total | 26 | 24 | 50 |
| Midstream format
| (dip method) | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 23 | 0 | 23 |
| Negative | 0 | 27 | 27 | |
| Total | 23 | 27 | 50 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Second study:
200 women's individual pregnancy status was self-tested. Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. All aliquots were
10
blind labeled by the person who prepared the samples and didn't take part in the sample testing. 100 laypersons tested the 5 mIU/mL hCG aliquots and 100 laypersons tested the 25 mIU/mL hCG aliquots. Each testing site had a study administrator to observe or monitor the studies by laypersons without providing assistance to the participants.
Summary
| hCG Concentration
(mIU/mL) | Lay person result | | The percentage of
correct results (%) |
|-------------------------------|--------------------|--------------------|------------------------------------------|
| | No. of
Positive | No. of
Negative | |
| 5 | 0 | 100 | 100% |
| 25 | 100 | 0 | 100% |
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
11. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream) are substantially equivalent to the predicate.