(130 days)
The FaStep™ Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use.
The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Midstream is designed for self-testing use.
FaStepTM Pregnancy Rapid Test Strip is sold as a strip format and FaStepTM Pregnancy Rapid Test Midstream is sold as a midstream format. Pregnancy Rapid Test Midstream consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep™ Pregnancy Rapid Test Strip is a single test strip. FaStep™ Pregnancy Rapid Test Midstream contains one test sealed in a desiccated aluminum pouch and Instructions for Use. FaStep™ Pregnancy Rapid Test Strip contains one test strip sealed in a desiccated aluminum pouch and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
The provided text is a 510(k) Summary for the FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream. It details the performance characteristics used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with predefined numerical targets for performance metrics. Instead, it describes various studies and their outcomes, implying that the acceptance criterion for each test was a successful demonstration of performance (e.g., no false positives/negatives at specific concentrations, 100% conformity).
However, we can infer the implicit acceptance criteria from the study design and reported "100% conformity" with results from professional testing or the predicate device. The primary performance characteristic where a specific numerical sensitivity is stated is 20 mIU/mL.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | 100% positive detection at 20 mIU/mL hCG. | FaStep™ Pregnancy Rapid Test Midstream (in-stream & dip) & FaStep™ Pregnancy Rapid Test Strip: At 20 mIU/mL, all 150 replicates across three operators and three lots yielded 100% positive results. At 0 and 10 mIU/mL, all 150 replicates yielded 100% negative results. The data shows a dose-response, with increasing positive rates between 12.5 mIU/mL and 17.5 mIU/mL, leading to 100% positive at 20 mIU/mL. The document explicitly states: "Based on the above results, the sensitivity of FaStep™ Pregnancy Rapid Test is demonstrated to be 20 mIU/mL." |
| Hook Effect | No hook effect observed at high hCG concentrations. | No hook effect was observed up to 500,000 mIU/mL hCG, as all tested concentrations (6,250 mIU/mL to 500,000 mIU/mL) gave a positive result. |
| Specificity | No false positive results from non-pregnant individuals. | 300 urine samples from normal, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups showed no false positive results. |
| Cross-Reactivity | No interference from tested cross-reactants. | No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, and 1000 uIU/mL hTSH. No effect of hCG ß-core fragment up to 500,000 pmol/L. |
| Interfering Substances | No interference from common substances within specified levels. | No interference effect was observed at tested concentrations for a long list of substances (e.g., Acetaminophen, Acetylsalicylic Acid, Albumin, etc.), urine pH (4-9), and urine density (1.000-1.035). |
| Method Comparison | 100% conformity with predicate device. | FaStep™ Pregnancy Rapid Test Strip: 100% conformity (74 positive, 66 negative, total 140) with the predicate device. FaStep™ Pregnancy Rapid Test Midstream (in-stream method): 100% conformity (65 positive, 62 negative, total 127) with the predicate device. FaStep™ Pregnancy Rapid Test Midstream (dip method): 100% conformity (65 positive, 62 negative, total 127) with the predicate device. |
| Lay Person Study | 100% conformity with professional results and ease of use. | FaStep™ Pregnancy Rapid Test Strip: 100% conformity (74 positive, 66 negative, total 140) with professional results. FaStep™ Pregnancy Rapid Test Midstream: 100% conformity (65 positive, 62 negative, total 127) with professional results. Consumers found the test easy to use and understood the labeling and interpretation. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Analytical Performance (Sensitivity/Precision/Reproducibility):
- For each hCG concentration (0, 10, 12.5, 15, 17.5, 20, 50, 100, 200 mIU/mL): 10 replicates per day for 5 days per device lot, tested by 3 operators.
- Total tests per hCG concentration per device format (Strip, Midstream in-stream, Midstream dip): 10 * 5 * 3 = 150 tests.
- Data provenance: Not explicitly stated where the urine samples were collected, but they were "spiked with hCG standard". This is a laboratory-controlled study.
- Specificity: 300 urine samples from normal, non-pregnant females (100 pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
- Method Comparison Study: 267 urine samples from women presenting to test for pregnancy (139 pregnant, 128 non-pregnant - determined by predicate). Used for both FaStep™ Pregnancy Rapid Test Strip (N=140 subset) and FaStep™ Pregnancy Rapid Test Midstream (N=127 subset).
- Lay Person Study: Same sample sizes as the Method Comparison study, using the same subjects (140 for Strip, 127 for Midstream).
- Data provenance: Retrospective or prospective is not explicitly stated. The samples for the method comparison and lay person studies were "collected from women presenting to test for pregnancy," which suggests a more prospective real-world sample collection, although the overall study itself is likely a retrospective analysis of collected samples for regulatory submission. Country of origin not specified, but the submitter is from Hangzhou, China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Analytical Performance (Sensitivity/Precision/Reproducibility): The ground truth (hCG concentration) was established by spiking with hCG standard traceable to the 5th WHO. The tests were performed by "three different operators." Their qualifications are not specified beyond being "operators." This appears to be a laboratory-controlled study rather than using clinical experts to establish ground truth.
- Specificity Study: The ground truth for specificity (non-pregnant) seems to be based on the source of the urine samples ("normal, non-pregnant female"). No explicit expert adjudication process is described for confirming this.
- Method Comparison Study: The ground truth was established by the predicate device. The text states "All samples were tested with candidate and predicate devices at three POC sites." While a predicate device serves as the reference, it's not "expert opinion."
- Lay Person Study: The ground truth was established by "professional testing." The number and qualifications of these "professionals" are not specified in the document.
4. Adjudication Method for the Test Set
- Analytical Performance: No adjudication method is explicitly stated. The results were visually read by the operators (implied), and then aggregated.
- Specificity, Cross-Reactivity, Interfering Substances, Hook Effect: These were laboratory studies with results determined by the test reactivity. No human adjudication is mentioned.
- Method Comparison and Lay Person Study: No explicit adjudication method (e.g., 2+1 or 3+1) is mentioned. The professional results (ground truth for lay person study) and predicate device results (ground truth for method comparison) appear to be taken as definitive.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was NOT done. This device is a rapid, visual immunoassay for qualitative detection of hCG in urine. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images or data where AI assistance would be relevant. The "lay person study" is a comparison of lay users vs. professional results for the device itself, not AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as this is a qualitative immunoassay test kit, not an algorithm or software. The device itself is "standalone" in that it produces a visual result directly. The "professional" testing mentioned in the lay person study implies a human interpreting the device, but the device's mechanism is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance (Sensitivity): Spiking with WHO traceable hCG standard.
- Specificity, Hook Effect, Cross-Reactivity, Interfering Substances: Laboratory-controlled studies using spiked samples or naturally occurring non-pregnant/specific samples, with the expected outcome (positive/negative) serving as ground truth.
- Method Comparison Study: The predicate device's results served as the ground truth.
- Lay Person Study: "Professional results" served as the ground truth. The nature of these professional results (e.g., expert interpretation of the device, or results from a laboratory reference method) is not explicitly detailed but implies a more definitive and reliable determination than the lay person's self-test.
8. The Sample Size for the Training Set
- This information is not provided. The document describes clinical and analytical performance studies (i.e., test set data) for regulatory submission, but does not detail the development or training of any underlying models, as this is a biochemical assay, not an AI/ML device requiring distinct training and test sets in the typical sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as this is a biochemical immunoassay and does not involve AI/ML models with training sets and associated ground truth establishment methods. The document primarily focuses on validation testing and performance characteristics.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2024
Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K233174
Trade/Device Name: FaStep™ Pregnancy Rapid Test Strip; FaStepTM Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: December 19, 2023 Received: December 19, 2023
Dear Joe Shia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Division Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233174
Device Name FaStep™ Pregnancy Rapid Test Strip FaStepTM Pregnancy Rapid Test Midstream
Indications for Use (Describe)
The FaStep" Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use.
The FaStep M Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Midstream is designed for self-testing use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| K233174 | ||
|---|---|---|
| 1. | Date: | February 5, 2024 |
| 2. | Submitter: | Assure Tech. (Hangzhou) Co., Ltd.2nd. Floor, Building 1, No.10, Xiyuansan RoadWestlake Economic Zone, Hangzhou, 310030China |
| 3. | Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com |
| 4. | Device Name: | FaStep™ Pregnancy Rapid Test StripFaStep™ Pregnancy Rapid Test Midstream |
| Classification: | Class II | |
| Product Code: | LCX | |
| CFR: | 862.1155 | |
| 5. | Predicate Devices: | Fastep™ At-Home Pregnancy Test(K122907) |
6. Intended Use
The FaStep™ Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use.
The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStepTM Pregnancy Rapid Test Midstream is designed for self-testing use.
7. Device Description
FaStepTM Pregnancy Rapid Test Strip is sold as a strip format and FaStepTM
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FaStep™ Pregnancy Rapid Test Midstream is sold as a midstream format. Pregnancy Rapid Test Midstream consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep™ Pregnancy Rapid Test Strip is a single test strip. FaStep™ Pregnancy Rapid Test Midstream contains one test sealed in a desiccated aluminum pouch and Instructions for Use. FaStep™ Pregnancy Rapid Test Strip contains one test strip sealed in a desiccated aluminum pouch and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
| Intended use | Early detection of pregnancy | Early detection of pregnancy |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic assay | Immunochromatographic assay |
| Sensitivity | 20 mIU/mL | 20 mIU/mL |
| Results | Qualitative | Qualitative |
| Read time | 3-10 minutes | 3-5 minutes |
| Device format | Midstream, Strip | Midstream |
| Target user | Over the counter use | For over-the-counter |
Substantial Equivalence Information 8.
Test Principle 9.
FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream use lateral flow immunoassay for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. If hCG is present in the sample, it will reach the Test Zone ("T") of the membrane and form a colored line. When the test is performed properly, a colored line will always appear in the Control Zone ("C"). The test result is shown on the strip (for the strip version) or in the result window (for the midstream version) and read visually between 3 and 10 minutes of urine application. Two distinct colored lines, one in the Test Zone and another in the Control Zone indicate a positive test result (pregnant). Absence of a colored line in the Test Zone and only a colored line in the Control Zone indicates a negative test result (not pregnant). Absence of a colored line in the Control Zone even in the presence of a colored line in the Test Zone indicates an invalid test result.
10. Performance Characteristics
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A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 10, 12.5, 15, 17.5, 20, 50, 100 and 200 mIU/mL. Each sample was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested. Tests were performed by three different operators for each sample concentration.
The results are summarized in the table below:
| hCGConcentration(mIU/mL) | Operator 1Lot 1 | Operator 2Lot 2 | Operator 3Lot 3 | Totalresult | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 46 | 4 | 45 | 5 | 43 | 7 | 134 | 16 | 89.3% | 10.7% |
| 15 | 22 | 28 | 27 | 23 | 25 | 25 | 74 | 76 | 49.3% | 50.7% |
| 17.5 | 6 | 44 | 6 | 44 | 5 | 45 | 17 | 133 | 11.3% | 88.7% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
FaStepTM Pregnancy Rapid Test Midstream (in-stream method)
FaStep™ Pregnancy Rapid Test Midstream format (dip method)
| hCGConcentration(mIU/mL) | Operator1Lot 1 | Operator2Lot 2 | Operator3Lot 3 | Totalresult | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 44 | 6 | 44 | 6 | 46 | 4 | 134 | 16 | 89.3% | 10.7% |
| 15 | 24 | 26 | 26 | 24 | 27 | 23 | 77 | 73 | 51.3% | 48.7% |
| 17.5 | 7 | 43 | 5 | 45 | 4 | 46 | 16 | 134 | 10.7% | 89.3% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
FaStep™ Pregnancy Rapid Test Strip
| hCGConcentration | Operator1 | Operator2 | Operator3 | Totalresult | %Negative | %Positive |
|---|---|---|---|---|---|---|
| ---------------------- | --------------- | --------------- | --------------- | ----------------- | --------------- | --------------- |
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| (mIU/mL) | Lot 1 | Lot 2 | Lot 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 45 | 5 | 45 | 5 | 44 | 6 | 134 | 16 | 89.3% | 10.7% |
| 15 | 23 | 27 | 26 | 24 | 24 | 26 | 73 | 77 | 48.7% | 51.3% |
| 17.5 | 7 | 43 | 5 | 45 | 6 | 44 | 18 | 132 | 12.0% | 88.0% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
FaStepTM Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream exhibited reproducibility of results.
Based on the above results, the sensitivity of FaStep™ Pregnancy Rapid Test is demonstrated to be 20 mIU/mL.
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test.
Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream are calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
Stability:
A 27-month real time stability test was carried out to verify the shelf-life stability of the device. Three batches for each format in sealed foil pouch are stable for 30 months at 2℃ and 30℃, and the shelf-life is claimed to be 24 months.
d. Specificity and cross reactivity
To evaluate specificity, 300 urine samples were collected from normal, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. In each age group, 50 participants were tested with test midstream
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using dip method, and 50 participants tested with test midstream using in-stream method. No false positive results were observed for any of the age groups.
To evaluate cross-reactivity, negative and positive urine samples (0, 10 and 20 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 uIU/mL hTSH). No cross-reactivity was observed at tested concentration.
To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 10 mIU/mL hCG) and positive urine samples (20 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. The performance of FaStep™ Pregnancy Rapid Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
e. Interfering substance
To evaluate potential interference with FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:
| Substance | Concentration |
|---|---|
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic Acid | 20 mg/dL |
| Albumin | 2000 mg/dL |
| Amoxicillin | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Ascorbic acid | 20 mg/dL |
| Aspirin | 80 mg/dL |
| Atropine | 20 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Bilirubin | 40 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| EDTA | 80 mg/dL |
| Ephedrine | 20 mg/dL |
| Ethanol | 1% |
| Folic acid | 0.03 mg/dL |
| Gentisic acid | 20 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Ibuprofen | 40 mg/dL |
| Ketone | 20 mg/dL |
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| Methanol | 1% |
|---|---|
| Phenothiazine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Pregnanediol | 1.5 mg/dL |
| Salicylic Acid | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Thiophene | 20 mg/dL |
| Uric acid | 23.5 mg/dL |
| Vitamin B1 | 80 mg/dL |
| β-hydroxybutyrate | 2000 mg/dL |
To evaluate the effect of urine pH on the results of FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of FaStep™ Pregnancy Rapid Test.
To evaluate the effect of urine density on the results of FaStep™ Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream, urine samples containing 0, 10 and 20 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.011, 1.015, 1.019, 1.024, 1.029 and 1.035. The results indicated that urine with a relative density of 1.000 to 1.035 does not affect the performance of FaStepTM Pregnancy Rapid Test.
B. Method comparison study
Method comparison with predicate device
The performance of the FaStepTM Pregnancy Rapid Test Strip and FaStepTM Pregnancy Rapid Test Midstream was compared to the predicate test. Urine samples were collected from 267 women presenting to test for pregnancy. Total of the 139 women were pregnant and they were all in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites.
| Candidate device | Predicate device | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| FaStep™ Pregnancy Rapid TestStrip | Positive | 74 | 0 | 74 |
| Negative | 0 | 66 | 66 | |
| Total | 74 | 66 | 140 |
The results are summarized in the table below.
| Candidate device | Predicate device | Negative | Total | |
|---|---|---|---|---|
| Positive | ||||
| FaStep™ Pregnancy Rapid Test | Positive | 65 | 0 | 65 |
| Midstream (in-stream method) | Negative | 0 | 62 | 62 |
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| Total | 65 | 62 | 127 | |
|---|---|---|---|---|
| Candidate device | Predicate device | |||
| Positive | Negative | Total | ||
| FaStepTM Pregnancy Rapid TestMidstream (dip method) | Positive | 65 | 0 | 65 |
| Negative | 0 | 62 | 62 | |
| Total | 65 | 62 | 127 |
The conformity between FaStep™ Pregnancy Rapid Test Strip, FaStep™ Pregnancy Rapid Test Midstream and the predicate device is 100%.
C. Lay person study
267 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing. The results are summarized in the table below.
A total of 140 subjects tested their urine samples using the FaStep™ Pregnancy Rapid Strip
| FaStep™ Pregnancy Rapid Test Strip | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 74 | 0 | 74 |
| Negative | 0 | 66 | 66 | |
| Total | 74 | 66 | 140 |
A total of 127 lay users tested their urine samples using the FaStepTM Pregnancy Rapid Midstream.
| FaStep™ Pregnancy Rapid TestMidstream(instream and dip method) | Professional Result | |||
|---|---|---|---|---|
| Positive(+) | Negative(- ) | Total | ||
| Lay User Result | Positive (+) | 65 | 0 | 65 |
| Negative (-) | 0 | 62 | 62 | |
| Total | 65 | 62 | 127 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
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11. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream are substantially equivalent to the predicate.
§ 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.