(27 days)
WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.
The provided document describes the performance characteristics of the WHOLEPOWER Pregnancy Rapid Test (Cassette, Strip, Midstream). Here's a breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document defines certain performance thresholds, particularly for sensitivity and agreement with a predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | 100% positive detection at 25 mIU/mL hCG | Strip Format: 100% positive at 25 mIU/mL (90/90). Cassette Format: 100% positive at 25 mIU/mL (90/90). Midstream Format: 100% positive at 25 mIU/mL (90/90). The overall sensitivity is demonstrated to be 25 mIU/mL. |
| 100% negative detection at 0 and 12.5 mIU/mL hCG | Strip Format: 100% negative at 0 mIU/mL (90/90) and 12.5 mIU/mL (90/90). Cassette Format: 100% negative at 0 mIU/mL (90/90) and 12.5 mIU/mL (90/90). Midstream Format: 100% negative at 0 mIU/mL (90/90) and 12.5 mIU/mL (90/90). | |
| Hook Effect | No hook effect observed at high hCG concentrations | No hook effect was observed at hCG concentrations ranging from 62500 to 2000000 mIU/mL. |
| Specificity/Cross-Reactivity | No interference from common glycoprotein hormones | No interference observed at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH, and 2000,000 pmol/L hCG ß-core fragment. |
| Interfering Substances | No interference from a list of common exogenous compounds | No interferences observed from a comprehensive list of exogenous compounds at specified concentrations (e.g., Acetaminophen 20mg/dL, Caffeine 20mg/dL, Ethanol 1.0%, Glucose 2000mg/dL, Hemoglobin 500mg/dL, etc.). No interference from changes in pH (4-9) or specific gravity (1.002-1.032). |
| Method Comparison | Over 98% agreement with the predicate device | Strip Format: 63 positive, 56 negative (1 disagreement). Agreement: (63+56)/120 = 99.17%. Cassette Format: 64 positive, 56 negative (0 disagreement). Agreement: (64+56)/120 = 100%. Midstream Format: 64 positive, 56 negative (0 disagreement). Agreement: (64+56)/120 = 100%. The results indicate an over 98% agreement. |
| Lay Person Study | 100% positive and >97% negative conformity with professional results | Strip Format: 100% positive conformity (53/53), 97.9% negative conformity (46/47). Cassette Format: 100% positive conformity (48/48), 100% negative conformity (52/52). Midstream Format: 100% positive conformity (40/40), 98.3% negative conformity (59/60). Overall, the lay person results showed 100% positive and >97% negative conformity with professional results. |
| Labeling Comprehension | Consumers found the test easy to use and understood labeling/results | Questionnaire results reflected that consumers found the test easy to use and did not have trouble understanding the labeling and interpreting the results. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Analytical Performance (Precision/Reproducibility/Sensitivity):
- Test Set Size: For each hCG concentration level (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), there were 3 lots * 30 replicates (3 operators * 2 runs/day * 15 days, which seems to imply 30 replicates per lot for each concentration if the 15 days * 2 runs * 3 operators is across all lots, or 30 replicates come from something else). The table shows 30 replicates per lot per concentration for each format (Strip, Cassette, Midstream). So, 8 hCG concentrations * 3 lots * 30 replicates = 720 tests per format across all sensitivity tests.
- Data Provenance: Negative urine was spiked with hCG standard. The source of the negative urine or the location of the testing is not specified, but the product submitter is Wholepower Biotech Co., Ltd. from China. This study appears to be laboratory-controlled.
- Method Comparison Study with Predicate Device:
- Test Set Size: 120 urine samples from women.
- Data Provenance: Urine samples were collected from 120 women presenting to test for pregnancy at OB/GYN Physician's offices. It is a prospective study as samples were collected for the study. The country of origin is not explicitly stated but implied to be where the applicant would conduct clinical studies.
- Lay Person Study:
- Test Set Size: 300 individual women.
- Data Provenance: Women from "three sites were chosen for the study." The country of origin is not explicitly stated. It is a prospective study, involving self-testing by participants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Analytical Performance: The ground truth for hCG concentrations was established by spiking negative urine with hCG standards "Traceable to the 4th WHO." No human experts were involved in establishing the ground truth for these spiked samples, as it's a controlled laboratory preparation.
- Method Comparison Study: "All samples were tested by two different health professionals for each format at each of the 3 OB/GYN Physician's offices for a total of 18 operators with the proposed and the predicate devices." The ground truth was based on the predicate device and the new device results, observed by these health professionals. Their qualifications are listed as "health professionals," but no specific details (e.g., years of experience, specialty) are provided.
- Lay Person Study: "Each subject also provided a sample for professional testing with the candidate device as well." The ground truth for the lay person study was established by "professional testing," presumably referring to qualified laboratory personnel or healthcare professionals. Their specific number and qualifications are not detailed beyond "professional testing."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Analytical Performance: Not applicable, as the ground truth was based on precisely prepared spiked samples.
- Method Comparison Study: The document states, "All samples were tested by two different health professionals for each format...". It doesn't explicitly detail an adjudication method beyond two professionals testing. It compares the new device's results with the predicate device's results. It's not clear if there was independent adjudication for discrepancies between the two health professionals' readings or between the new device and predicate. The agreement percentages suggest a direct comparison rather than a consensus-based adjudication from multiple readers.
- Lay Person Study: The comparison is between "Lay person" results and "Professional" results. There is no mention of an adjudication process among multiple professionals or for discrepancies between lay persons' results and professional results if they exist. The "Professional" result serves as the reference.
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
There is no mention of an AI-assisted device or an MRMC comparative effectiveness study where human readers improve with AI assistance. This device is a rapid diagnostic test, not an AI-powered image analysis system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The WHOLEPOWER Pregnancy Rapid Test is a point-of-care, visually interpreted immunoassay. It does not involve an algorithm or an AI component operating in a standalone manner. The "standalone" performance here refers to the device's ability to provide a result, which is then interpreted by a human user (either a health professional or a lay person).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Analytical Performance: Ground truth was established by spiking negative urine with known concentrations of hCG standards traceable to WHO International Standard.
- Method Comparison Study: The ground truth for the comparison was primarily based on the results obtained from a legally marketed predicate device on patient urine samples, observed by health professionals.
- Lay Person Study: The ground truth was established by professional testing using the candidate device on the same urine samples as the lay persons.
8. The sample size for the training set
The document does not describe any machine learning or AI components, and therefore no explicit "training set" in the context of AI development is mentioned. The studies described are for analytical and clinical performance validation of a rapid diagnostic test.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2019
Wholepower Biotech Co., Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K190705
Trade/Device Name: WHOLEPOWER Pregnancy Rapid Test Cassette WHOLEPOWER Pregnancy Rapid Test Strip WHOLEPOWER 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: March 15, 2019 Received: March 19, 2019
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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K190705
510(k) SUMMARY
| 1. | Date: | April 12, 2019 |
|---|---|---|
| 2. | Submitter: | Wholepower Biotech Co., Ltd.Dongfengdong Road, Guangzhou,China 510008 |
| 3. | Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite JGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com |
| 4. | Device Name: | WHOLEPOWER® Pregnancy Rapid Test CassetteWHOLEPOWER® Pregnancy Rapid Test MidstreamWHOLEPOWER® Pregnancy Rapid Test Strip |
| Classification: | Class II | |
| Product Code | LCX | |
| CFR | 862.1155 | |
| 5. | Predicate Devices: | WHPM One Step Pregnancy Test (K041273) |
6. Intended Use
WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
7. Device Description
WHOLEPOWER Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and
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Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate deviceK041273, WHPM OneStep Pregnancy Test |
| Intended use | Early detection ofpregnancy | Early detection ofpregnancy |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographicassay | Immunochromatographicassay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Differences | ||
| Item | Device | Predicate |
| Reading Time | 3 minute | 5 minute |
Substantial Equivalence Information 8.
9. Test Principle
The test uses colloidal gold immunochromatography assay to detect human chorionic gonadotropin (hCG) in urine at cut-off 25 mIU/ml. When hCG concentration is higher than the cut-off, it will bind to rat anti ß-hCG Mab which is labelled by colloidal gold. As the sample migrates on the nitrocellulose matrix of test strip by tomographic action, the complexes of detector antibody with ßhCG are separately captured to a-hCG antibody that has been immobilized on test strip, a red line appears in test zone (T) and the test result is positive. When hCG concentration is lower than the cut-off, there is no red line shows in test zone (T) and test result is negative. There is goat anti-mouse IgG polyclonal antibody immobilized in nitrocellulose filter membrane control zone (C) that bind to rat anti ß-hCG Mab labelled by colloidal gold. When proper amount sample is applied a red line will appear in control zone (C).
10. Performance Characteristics
A. Analytical performance
- a. Precision/Reproducibility/Sensitivity
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Negative urine was spiked with hCG standard (Traceable to the 4th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:
| hCG | Lot 1 | Lot 2 | Lot 3 | Totalresult | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Concentration(mIU/mL) | - | + | - | + | - | + | - | + | ||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 21 | 9 | 24 | 6 | 23 | 7 | 68 | 22 | 76 | 24 |
| 22.5 | 1 | 29 | 1 | 29 | 0 | 30 | 2 | 88 | 2 | 98 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Strip format
Cassette format
| hCG | Lot 1 | Lot 2 | Lot 3 | Totalresult | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Concentration(mIU/mL) | - | + | - | + | - | + | - | + | ||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 23 | 7 | 22 | 8 | 25 | 5 | 70 | 20 | 78 | 22 |
| 22.5 | 0 | 30 | 1 | 29 | 3 | 27 | 4 | 86 | 4 | 96 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Midstream format
| hCGConcentration(mIU/mL) | Lot 1 | Lot 2 | Lot 3 | Totalresult | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 23 | 7 | 26 | 4 | 71 | 19 | 79 | 21 |
| 22.5 | 2 | 28 | 1 | 29 | 2 | 28 | 5 | 85 | 6 | 94 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
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| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
|---|---|---|---|---|---|---|---|---|---|---|
| ----- | --- | ---- | --- | ---- | --- | ---- | --- | ---- | --- | ----- |
Based on the above results, the sensitivity of WHOLEPOWER® 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.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 62500 to 2000000 mIU/mL.
d. Traceability, Stability, Expected values (controls, calibrators, or methods): WHOLEPOWER® Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 4th edition.
A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are on going.
e. Specificity and cross reactivity
To evaluate specificity and cross-reactivity, negative and positive urine samples (12.5 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.
| Substances | Concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Asorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
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| Salicylic Acid | 20mg/dL |
|---|---|
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |
| Albumin | 2000mg/dL |
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
To evaluate potential interference from changes in pH, urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.002, 1.007, 1.012, 1.018, 1.025 and 1.032. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
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 120 women presenting to test for pregnancy at OB/GYN Physician's offices. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by two different health professionals for each format at each of the 3 OB/GYN Physician's offices for a total of 18 operators with the proposed and the predicate devices.
| Strip Format | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER®Rapid Pregnancy Test | Positive | 63 | 1 |
| Negative | 0 | 56 |
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| Cassette | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER®Rapid Pregnancy Test | Positive | 64 | 0 |
| Negative | 0 | 56 |
| Midstream | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER®Rapid Pregnancy Test | Positive | 64 | 0 |
| Negative | 0 | 56 |
The above results indicate an over 98% agreement between the proposed and the predicate.
C. Lay person study:
300 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the candidate device according to the package insert. Each subject also provided a sample for professional testing with the candidate device as well. Summary
| WHOLEPOWER Pregnancy Rapid TestStrip | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 53 | 0 |
| - | 1 | 46 | |
| WHOLEPOWER Pregnancy Rapid TestCassette | Professional | ||
| + | - | ||
| Lay person | + | 48 | 0 |
| - | 0 | 52 |
| WHOLEPOWER Pregnancy Rapid Test | Professional | ||
|---|---|---|---|
| Midstream | + | - | |
| Lay person | + | 40 | 0 |
| - | 1 | 59 |
From the above tables, the lay person results showed 100% positive and >97% 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
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use and that they did not have trouble understanding the labeling and interpreting the results.
11. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 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.