(121 days)
Not Found
No
The summary describes a standard digital pregnancy test based on the detection of hCG in urine. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of these methods. The performance studies focus on analytical performance and comparison with a predicate device, not on the evaluation of an AI/ML algorithm.
No
The device aids in the early detection of pregnancy by detecting hCG in urine. It does not treat or prevent any medical condition.
Yes
The device qualitatively detects human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device description explicitly states it consists of a "single test strip assembled in a plastic housing, with an absorbent tip," indicating it is a physical hardware device for in vitro diagnostic testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy." This is a diagnostic purpose performed on a biological sample (urine).
- Device Description: The description states it's used for "in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- "Only for use outside the body": This further reinforces that the test is performed on a sample taken from the body, not directly on the body itself.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MissLanTM Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in 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
LCX
Device Description
MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.
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.
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
- Precision/Reproducibility/Sensitivity:
- Method: 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 by both dip and midstream methods in 10 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration.
- Key Results: MissLan™ Digital Pregnancy Rapid Test exhibited reproducible results. The sensitivity of MissLan™ Digital Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
- Linearity/assay reportable range:
- Linearity is not applicable since this is a qualitative test.
- Hook effect test: Negative urine samples were spiked with varying hCG concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result.
- Key Results: No hook effect was observed at hCG concentration up to 500,000 mIU/mL.
- Traceability, Stability, Expected values (controls, calibrators, or methods):
- Traceability: 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. Three batches are stable for 24 months at 2°C and 30°C, and the real time stability study is still on going.
- Specificity and cross reactivity:
- Specificity: 300 urine samples were collected from healthy, non-pregnant females (100 each from pre-menopausal, peri-menopausal, and post-menopausal groups). Both dip and midstream testing were evaluated.
- Key Results: No false positive results were observed for any age group.
- 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 uIU/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: Performance is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
- Interfering substance:
- Method: 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 substances including 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: Urine pH ranges between 4 and 9 does not affect the performance.
- 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: Urine with a relative density of 1.000 to 1.035 does not affect the performance.
B. Method comparison study
- Method: Urine samples were collected from 200 women presenting to test for pregnancy, approximately half of whom were suspected to be pregnant (early stage, 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).
- Sample Size: 200 women's urine samples.
- Key Results: The conformity between MissLan™ Digital Pregnancy Rapid Test (midstream method / dip method) and the predicate device is 100%.
C. Lay person study
- First study:
- Method: 200 women self-tested their individual pregnancy status. Individuals with varying educational and occupational backgrounds from three sites were chosen. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
- Sample Size: 200 women.
- Key Results: The lay person results showed 100% positive and 100% negative conformity with the professional results.
- Second study:
- Method: 200 women self-tested. Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. All aliquots were blind labeled. Both laypersons and professionals used dip method to test the samples. 100 laypersons tested the 5 mIU/mL hCG aliquots and 100 laypersons tested the 25 mIU/mL hCG aliquots.
- Sample Size: 200 women.
- Key Results: The percentage of correct results for both 5 mIU/mL hCG (negative interpretation) and 25 mIU/mL hCG (positive interpretation) was 100% for laypersons compared to professional results. Questionnaire results indicated consumers found the test easy to use and understood labeling/results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity: 25 mIU/mL
- Specificity: 100% (based on specificity study with healthy non-pregnant females)
- Conformity: 100% (for both midstream and dip methods compared to predicate device; also for layperson studies compared to professional results)
Predicate Device(s):
Preview® Digital Pregnancy Test (K173229)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 30, 2022
Guangzhou Decheng Biotechnology Co., Ltd. % Joe Shia, Director LSI International 504 E Diamond Ave. Suite I Gaithersburg, MD 20877
Re: K222305
Trade/Device Name: MissLan™ Digital Pregnancy Rapid Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: LCX Dated: July 31, 2022 Received: August 2, 2022
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 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
1
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 -S Caposino -S Date: 2022.11.30
17:02:33 -05'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222305
Device Name MissLanTM Digital Pregnancy Rapid Test
Indications for Use (Describe)
MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY K22305
| 1. | Date: | November 29, 2022 |
|---|---|---|
| 2. | Submitter: | Guangzhou Decheng Biotechnology Co., Ltd. |
| Building 2, No. 68, 1st Nanxiang Road, Science | ||
| City, Huangpu District, 510000 Guangzhou, | ||
| Guangdong, 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: | |
| Classification: | ||
| Product Code: | ||
| CFR: | MissLan™ Digital Pregnancy Rapid Test | |
| Class II | ||
| LCX | ||
| 862.1155 | ||
| 5. | Predicate Devices: | Preview® Digital Pregnancy Test (K173229) |
6. Intended Use
MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in 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
MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-touse format.
8. Substantial Equivalence Information
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
4
| 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 |
| Target user | Over the counter use | Over the counter use |
| Sample application | Midstream and dip
methods | Midstream and dip methods |
| Readout | Digital/LCD screen | Digital/LCD screen |
| Differences | | |
| Item | Device | Predicate |
| Appearance | 155.5 x 21.5 x 14.5 mm | 150 x 25 x 15 mm |
9. Test Principle
MissLan™ Digital Pregnancy Rapid Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
10. Performance Characteristics
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 by both dip and midstream methods in 10 replicates per day for 5 days for each device lot. Total of three device lots 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 | 23 | 27 | 24 | 26 | 24 | 26 | 71 | 79 | 47% | 53% |
| 18.75 | 12 | 38 | 11 | 39 | 11 | 39 | 34 | 116 | 23% | 77% |
Midstream Testing
5
| 22.5 | 5 | 45 | 5 | 45 | 6 | 44 | 16 | 134 | 11% | 89% |
|---|---|---|---|---|---|---|---|---|---|---|
| 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% |
Dip Testing
| hCG
Concentration | Operator
1 | | Operator
2 | | Operator
3 | | Total
result | | %
Negative | %
Positive |
|----------------------|---------------|----|---------------|----|---------------|----|-----------------|-----|---------------|---------------|
| (mIU/mL) | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 24 | 26 | 24 | 26 | 25 | 25 | 73 | 77 | 49% | 51% |
| 18.75 | 12 | 38 | 11 | 39 | 12 | 38 | 35 | 115 | 23% | 77% |
| 22.5 | 4 | 46 | 5 | 45 | 5 | 45 | 14 | 136 | 9% | 91% |
| 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% |
Overall Testing
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|-------|-----|-------|-----|-------|-----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0 | 100% | 0% |
| 12.5 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0 | 100% | 0% |
| 15 | 47 | 53 | 48 | 52 | 49 | 51 | 144 | 156 | 48% | 52% |
| 18.75 | 24 | 76 | 22 | 78 | 23 | 77 | 69 | 231 | 23% | 77% |
| 22.5 | 9 | 91 | 10 | 90 | 11 | 89 | 30 | 270 | 10% | 90% |
| 25 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 50 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 200 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
MissLan™ Digital Pregnancy Rapid Test exhibited reproducible results. Based on the above results, the sensitivity of MissLan™ Digital Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.
6
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™ Digital 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 of products in sealed foil pouch are currently stable for 24 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, 300 urine samples were collected from healthy, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and midstream testing are evaluated. 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 uIU/mL hTSH). No cross-reactivity was observed at tested concentration.
To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 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™ Digital 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™ Digital 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 |
7
| 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 |
| ẞ-hydroxybutyrate | 2000 mg/dL |
| 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™ Digital 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™ Digital Pregnancy Rapid Test.
To evaluate the effect of urine density on the results of MissLan™ Digital 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 1.000 to 1.035 does not affect the performance of MissLan™ Digital 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
8
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).
| Midstream method | Predicate device | |||
|---|---|---|---|---|
| Candidate device | Positive | Negative | Total | |
| Positive | 55 | 0 | 55 | |
| Negative | 0 | 45 | 45 | |
| Total | 55 | 45 | 100 |
Summary midstream testing results
| Predicate device | ||||
|---|---|---|---|---|
| Dip method | Positive | Negative | Total | |
| Candidate device | Positive | 47 | 0 | 47 |
| Negative | 0 | 53 | 53 | |
| Total | 47 | 53 | 100 |
Summary dip testing results
The conformity between MissLan™ Digital Pregnancy Rapid Test (midstream method / dip method) 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. Summary
| Midstream method | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 55 | 0 | 55 |
| Negative | 0 | 45 | 45 | |
| Total | 55 | 45 | 100 |
| Dip method | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 47 | 0 | 47 |
| Negative | 0 | 53 | 53 | |
| Total | 47 | 53 | 100 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Second study:
9
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 blind labeled by the person who prepared the samples and didn't take part in the sample testing. Both laypersons and professionals use dip method to test the above samples. 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 | | Professional result | | The percentage of
correct results (%) |
|----------------------------------|--------------------|--------------------|---------------------|--------------------|------------------------------------------|
| | No. of
Positive | No. of
Negative | No. of
Positive | No. of
Negative | |
| 5 | 0 | 100 | 0 | 100 | 100% |
| 25 | 100 | 0 | 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 device, it's concluded that MissLan M Digital Pregnancy Rapid Test is substantially equivalent to the predicate.