(205 days)
The hCG Urine Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test will be sold in three formats: cassette, test strip, and midstream. The test strip and midstream kits consist of one test device and a package insert. The cassette kit consists of one test device and a disposable plastic dropper, and a package insert. Each test device contains mouse monoclonal anti-βhCG antibody coated membrane and a pad containing mouse monoclonal anti-α-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-rabbit IgG.
The provided document is an FDA 510(k) summary for a set of hCG Urine Test devices. This document focuses on demonstrating analytical performance and user comprehension/accuracy for an In-Vitro Diagnostic (IVD) device, specifically a pregnancy test, not an AI-powered medical device. Therefore, many of the requested criteria related to AI/MRMC studies, expert ground truth, and training sets are not applicable to this type of device and submission.
However, I can extract the relevant information regarding the acceptance criteria and study proving the device meets these for an IVD device.
Acceptance Criteria and Device Performance for hCG Urine Test Strip, Cassette, and Midstream
This submission primarily focuses on analytical performance characteristics and comparison studies to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Detection Limit) | Must accurately detect hCG at 25 mIU/mL (claimed sensitivity, matches predicate). | 100% positive detection for samples at 25 mIU/mL, 50 mIU/mL, and 100 mIU/mL across all formats and lots. |
| Analytical Precision/Reproducibility | Consistent results (positive/negative) across different lots, operators, and days for given hCG concentrations. | 100% agreement (positive/negative) for all tested concentrations (0 mIU/mL, 12.5 mIU/mL, 18.75 mIU/mL, 25 mIU/mL, 50 mIU/mL, 100 mIU/mL) across 3 lots, 3 operators, over 10 days for all three formats (strip, cassette, midstream via dip and simulated midstream). |
| Analytical Specificity (Cross-reactivity) | No interference from closely related hormones (LH, FSH, TSH) at specified concentrations. | No cross-reaction observed with LH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mL. |
| Analytical Specificity (Interfering Substances) | No interference from common exogenous compounds or endogenous substances at specified concentrations. | No interference observed from 14 listed substances (e.g., Acetaminophen, Aspirin, Glucose, Albumin, Bilirubin, etc.) at their specified challenge concentrations for both 0 mIU/mL and 25 mIU/mL hCG samples. |
| Analytical Specificity (hCG β-core fragment) | No interference from hCG β-core fragment at likely physiological levels. | No interference observed at β-core fragment concentrations up to 1,000,000 pmol/mL. |
| Analytical Specificity (pH) | Performance not affected by varying urine pH within a physiological range. | No interference observed for urine pH range of 3 to 9. |
| Analytical Specificity (Specific Gravity) | Performance not affected by varying urine specific gravity within a physiological range. | No interference observed for specific gravity between 1.001-1.039. |
| High Dose Hook Effect | Device should accurately detect high concentrations of hCG without false negatives (hook effect). | Positive results obtained for HCG concentrations ranging from 5,000 to 850,000 mIU/ml. |
| Comparison (Professional Use) | High agreement with the predicate device when interpreted by professionals. | 100% agreement (53 positive, 67 negative) with the predicate device for all three formats using urine samples from 120 women. |
| Comparison (Lay User Comprehension/Accuracy) | High agreement between lay user interpretation and professional interpretation (ground truth). | 100% conformity between lay user interpretation and professional interpretation for all three formats (strip, cassette, midstream dip, midstream actual) across 360 women. |
| OTC User Suitability | Untrained users can accurately use and interpret the test. | 100% agreement between lay user results and professional laboratory results for masked spiked samples (30 positive at 31.25 mIU/mL, 30 negative at 18.75 mIU/mL) for all formats. Participants rated the test as "very easy" or "easy" to read and interpret. |
| Shelf-life Stability | Maintain performance characteristics over the claimed shelf life. | Data supports a 30-month shelf life when stored at 4-30℃. |
2. Sample Sizes and Data Provenance
- Analytical Performance Studies (Precision, Specificity, Hook Effect, pH, Specific Gravity):
- Sample Size: Varies by test. For precision, it's 3 lots x 3 runs/day x 10 days x 6 concentrations = 540 tests per format per operator x 3 operators (though total tests are reported per concentration per lot, e.g., 30 results). For other analytical tests, specific numbers are not always given but imply multiple runs with spiked samples.
- Data Provenance: Fresh urine samples from normal, non-pregnant females, spiked with HCG or interfering substances. The origin of the samples (e.g., country) is not specified but the manufacturer is in Hangzhou, China. The studies are retrospective in the sense that they are laboratory-controlled experiments designed to test specific analytical characteristics.
- Comparison Studies (Professional Method):
- Sample Size: 120 women's urine samples.
- Data Provenance: Urine samples collected from women at a hospital laboratory. Origin not specified (likely China). Retrospective collection for testing by both devices.
- Comparison Studies (Lay User Method):
- Sample Size: 360 women.
- Data Provenance: Urine samples collected from women at a hospital laboratory. Origin not specified (likely China). Retrospective collection.
- OTC User Performance (Spiked Masked Samples):
- Sample Size: 30 positive samples (31.25 mIU/mL hCG) and 30 negative samples (18.75 mIU/mL hCG) were tested by lay users for each of the four test methods (strip, cassette, midstream dip, midstream simulated). So, 60 samples per format/method, totaling 240 masked spiked samples.
- Data Provenance: Spiked urine samples prepared in a laboratory setting. This is a prospective experimental design for evaluating lay user performance.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Analytical Studies: Ground truth for these studies (e.g., specific hCG concentrations, presence/absence of interfering substances) is established by the preparation of the samples themselves in a laboratory setting using traceable reference materials (e.g., WHO 5th IS for hCG). The "experts" here are essentially the laboratory personnel setting up and verifying these conditions. No specific number or qualifications are provided beyond general lab personnel.
- Professional Method Comparison: The "predicate device professional" interpretation serves as a comparator, implying professional users (e.g., lab technicians, medical staff) were involved in interpreting the predicate device results. The document does not specify the number of individuals or their specific qualifications.
- Lay User Method Comparison & OTC User Performance: The "professional interpretation of the hCG Test Strip/cassette/midstream" (Safecare device professional) appears to serve as the ground truth against which lay user interpretation/performance is compared. This implies that trained professionals used the new device to establish the correct result for each sample before the lay users interpreted their results. The number and qualifications of these "professionals" are not specified.
4. Adjudication Method for the Test Set
- For analytical studies, the "ground truth" is defined by the prepared samples (e.g., 25 mIU/mL hCG is positive, 0 mIU/mL is negative). No formal adjudication method is mentioned for reconciling conflicting results, as the expectation is 100% conformity based on the controlled sample preparation.
- For comparison studies (professional and lay user), the document states "the agreement of hCG Test Strip/cassette/midstream with the predicate device was 100%" or "the conformity between the user interpretation of the and the professional interpretation... is 100%." This implies that there were no discrepancies that required adjudication, or if there were, they are not reported. The "professional interpretation" acts as the reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is primarily relevant for AI-powered medical imaging devices where the AI assists human readers, and the goal is to show improved diagnostic performance with AI assistance. For a simple in-vitro diagnostic test like a pregnancy strip, this framework does not apply.
- The comparison studies involved both professional and lay users, but it was to compare the new device's performance against a predicate (professional) or a professional's interpretation of the new device (lay user), not to evaluate the effect of AI assistance on human readers.
6. Standalone (Algorithm-Only) Performance
- Yes, in the context of an IVD device, the "standalone" performance is assessed through the analytical performance studies. The device (the test kits) is the "algorithm," and its ability to correctly detect or not detect hCG at various concentrations (sensitivity, specificity, precision, hook effect, etc.) is its standalone performance demonstrated in the "Analytical performance" section. There is no separate digital algorithm being evaluated here.
7. Type of Ground Truth Used
- Analytical Studies: Lab-defined ground truth based on precisely prepared samples using traceable standards (e.g., WHO 5th IS for hCG) at specified concentrations. This is a form of spike-in ground truth.
- Professional Method Comparison: The results from the predicate device served as the comparator/reference.
- Lay User Method Comparison & OTC User Performance: The professional interpretation of the new device's results served as the ground truth.
8. Sample Size for the Training Set
- Not applicable. This document describes the validation of a manufactured in-vitro diagnostic test kit, not an AI/Machine Learning model that requires a training set. The device itself is a chemical-based test.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (As above, no training set for an AI/ML model here).
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2020
Safecare Biotech (Hangzhou) Co., Ltd. Selina Zhang Regulatory Affair 18 Haishu Road, Yuhang District Hangzhou, China
Re: K200133
Trade/Device Name: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: June 29, 2020 Received: June 29, 2020
Dear Selina Zhang:
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
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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 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,
Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200133
Device Name hCG Urine Test Strip hCG Urine Test Cassette hCG Urine Test Midstream
Indications for Use (Describe)
The hCG Urine Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5:
510(K) Summary
Date of Preparation: August 12, 2020
A. Applicant
Name: Safecare Biotech (Hangzhou) Co., Ltd. Address: 18 Haishu Road, Yuhang District, Hangzhou, China Official Contact Person Information Name: Selina Zhang Tel: 0086-571-89712897 Mail: selinazhang@safecare.com.cn
B. Device
Trade name:
hCG Urine Test Strip hCG Urine Test Cassette hCG Urine Test Midstream
| Common name: | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
|---|---|
| Classification name: | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
| Regulation Medical Specialty Clinical Chemistry | |
| Regulation Number | 862.1155 |
| Product Code | LCX |
| Classification | Class II |
C. Predicate device
510 (K) Number: K043443 One Step HCG Urine Pregnancy Test Produced by Guangzhou Wondfo Biotech Co., Ltd.
D. Intended use of the device
Intended use(s):
The hCG Urine Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The hCG Urine Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
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E. Device Description
The hCG Urine Test will be sold in three formats: cassette, test strip, and midstream. The test strip and midstream kits consist of one test device and a package insert. The cassette kit consists of one test device and a disposable plastic dropper, and a package insert. Each test device contains mouse monoclonal anti-βhCG antibody coated membrane and a pad containing mouse monoclonal anti-α-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-rabbit IgG.
F. Comparison with predicate
A summary comparison of the HCG Urine Test and the predicate devices is provided in the following Table:
| Device | New Device | Predicate (K043443) | Device Comparison |
|---|---|---|---|
| Manufacturer | Safecare Biotech (Hangzhou) Co., Ltd. | Guangzhou Biotech Co., Ltd. | NA |
| Intended use | early detection of pregnancy | early detection of pregnancy | Same |
| Specimen | Urine | Urine | Same |
| Sensitivity | 25mIU/mL | 25mIU/mL | Same |
| Indications | Over the Counter (OTC) | Over the Counter (OTC) | Same |
| Read time | 3-5 minutes | 5 minutes | Similar |
| Test Principle | Immunochromatographic assay | Immunochromatographic assay | Same |
| Format | Strip, cassette, midstream | Strip, cassette, midstream | Same |
| Result | Qualitative | Qualitative | Same |
There are no differences identified between new device and the predicate device for intended use, clinical cut-off, test principle, test format, etc. There is a minor difference in the reading time, the new device has a 3-5 minutes reading time while the predicate device has 5 minutes of reading time. However, this minor difference will not impact the safety or performance of the device. The HCG Urine Test Strip/cassette/midstream, and the predicate device use the same chemistry with essentially the same test design, thus they are substantial equivalent.
G. Standard/Guidance Document Referenced (if applicable)
Guidance for Over-the Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s
H. Test Principle
This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine, using a lateral flow sandwich immunochromatographic assay.
Performance characteristic l.
-
- Analytical performance
- a. Precision/Reproducibility:
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Fresh urine samples were took from normal, nonpregnant females spiked with the HCG (traceable to WHO 5th IS ) at different concentration 0mlU/ml, 18.75mlU/ml, 25mlU/ml, 50mlU/ml, 100mlU/ml. The study was conducted 3 runs / day and lasted 10 days and was conducted by 3 operators. There are 3 batches HCG Urine Test of three formats and each operator should conduct one batch separately. The midstream format was performed with both of these midstream test sample application methods (simulated midstream and dip). the result was recorded as the following:
The results of precision (strip)
| HCG | LOT 1 | LOT 2 | LOT 3 | |||
|---|---|---|---|---|---|---|
| concentration | positive | negative | positive | negative | positive | negative |
| 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results of precision (cassette)
| HCGconcentration | LOT 1 | LOT 2 | LOT 3 | |||
|---|---|---|---|---|---|---|
| positive | negative | positive | negative | positive | negative | |
| 0mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
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The results of precision (midstream, using the dip method)
| HCGconcentration | LOT 1 | LOT 2 | LOT 3 | |||
|---|---|---|---|---|---|---|
| positive | negative | positive | negative | positive | negative | |
| 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results of precision (midstream, using the simulated midstream method)
| HCGconcentration | LOT 1 | LOT 2 | LOT 3 | |||
|---|---|---|---|---|---|---|
| positive | negative | positive | negative | positive | negative | |
| 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results show that the precision of HCG Urine Test in 3 batches of different formats are good. HCG Urine Test exhibited reproducibility of results.
Based on the above results, the sensitivity is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
Not applicable. This is a qualitative assay.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
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Traceability:
The 510(k) describes traceability of the assay to the WHO 5th IS material. Stability testing was provided to support the claimed shelf life (30months).
Stability:
The stability data supports that the products have the shelf life of 30 months when stored at 4-30℃.
d. Detection limit/Sensitivity study:
See Precision section above. According to the results of precision data above, the sensitivity of HCG Urine Test is 25mlU/ml.
e. Analytical specificity:
e.1) To determine if the hCG Test Strip/cassette/midstream was affected (i.e. cross-reacted) by a relevant challenge dose of closely-related human lutieinzing hormone (hLH), human follicle stimulating hormone (hFSH) or human thyroid stimulating hormone (hTSH). The results demonstrated no cross reaction with LH at 500mlU/ml, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mL.
e.2) To evaluate the potential for interference by certain exogenous compounds and potentially interfering clinical conditions. Each substance was prepared by diluting stock interference material to the desired concentration. Normal, nonpregnant female's urine specimens containing 0 and 25mlU/ml HCG were spiked with the interferents to obtain the desired test concentration. Three batches of each format were tested. The results show that no interferences were observed from substance at the following concentrations for both negative and positive HCG urine samples.
| Interfering substances | Substances concentration |
|---|---|
| Acetaminophen | 20mg/mL |
| Aspirin | 20mg/dL |
| Ascorbic acid | 20mg/mL |
| Caffeine | 20mg/dL |
| Glucose | 200mg/dL |
| Hemoglobin | 1mg/mL |
| Tetracycline | 20mg/dL |
| Ampicillin | 20mg/dL |
| Albumin | 2000mg/dL |
| Bilirubin | 2mg/mL |
| Erythrocytes | >250/uL |
| Leukocyte | >500/ul |
| Uric acid | 450mMol/L |
| Ketone | > 80mg/dL |
| Ethanol | 1% |
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e.3) To evaluate the effects of the HCG ß-core fragment normal nonpregnant female urine specimens containing 0 and 25mlU/ml HCG were spiked with the HCG ß-core fragment (traceable to WHO reference reagent 99/708) at the concentration of 125000, 50000, 500000 and 1000000 pmol/mL. Three batches of each format were tested. The data shows that there's no interference in the test result when the HCG ß-core fragment at the highest levels at which it is likely to be found on patient samples.
e.4) PH study
The PH of an aliguot negative urine pool is adjusted to a PH range of 3 to 9 in 1 PH unit increments and spiked with HCG at 25mlU/ml and 0mIU/ml and 3 batches of HCG Urine Test were tested repeatedly. The result demonstrates that varying ranged of PH do not interfere with the performance of the test.
e.5) Specific gravity
Negative specimen 0 mIU/ml and specimen with HCG 25mlU/ml were formulated into the solution with specific gravity at 1.001, 1.020, 1.031, 1.039separately. Three lots of HCG Urine Test were tested. The data show that there's no interference in the test result when the specific gravity is between 1.001-1.039.
e.6) HOOK effect study
The test was evaluated for high dose hook effect. 30 HCG free specimens spiked with the HCG at different concentration containing 5,000mlU/ml, 10,000mlU/ml, 500,000mlU/ml, 650,000mIU/ml, 850,000mIU/ml,950,000mIU/ml. Three lot of tests for each format were tested. The result show that HCG Urine Test can get the positive result when the HCG concentration is range from 5,000 to 850,000 mIU/ml.
2. Comparison studies:
a. Professional method comparison
Urine samples were collected from 120 women at hospital laboratory to test for pregnancy. The data show that the agreement of hCG Test Strip/cassette/midstream with the predicate device was 100%.
| Candidate device | Predicate device professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Professional A | Positive | 53 | 0 |
| Negative | 0 | 67 | |
| Professional B | Positive | 53 | 0 |
| Negative | 0 | 67 |
The results of professional method comparison (strip)
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| Candidate device | Predicate device professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Professional A | Positive | 53 | 0 |
| Negative | 0 | 67 | |
| Professional B | Positive | 53 | 0 |
| Negative | 0 | 67 |
The results of professional method comparison (cassette)
The results of professional method comparison (midstream, using dip method)
| Candidate device | Predicate device professional | |
|---|---|---|
| Positive | Negative | |
| Professional A | 53 | 0 |
| 0 | 67 | |
| Professional B | 53 | 0 |
| 0 | 67 |
The results of professional method comparison (midstream, using the simulated method)
| Candidate device | Predicate device professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Professional A | Positive | 53 | 0 |
| Negative | 0 | 67 | |
| Professional B | Positive | 53 | 0 |
| Negative | 0 | 67 |
b. The lay user method comparison:
Urine samples were collected from 360 women at hospital laboratory to test for pregnancy. Ages were from 18 to 45 years. Out of the 360 women, 84 have an education background of middle school, 103 have an education background of high school, 84 have an education background of college degree, 59 have an education background of bachelor degree, 30 have an education background of Master & PhD degree. The conformity between the user interpretation of the and the professional interpretation of the hCG Test Strip/cassette/midstream is 100%.
The results of the lay user method comparison (strip)
| Safecare device | Safecare device professional | Total | |
|---|---|---|---|
| Positive | Negative |
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Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China
| Layusers | Positive | 33 | 0 | 33 |
|---|---|---|---|---|
| Negative | 0 | 57 | 57 | |
| Total | 33 | 57 | 90 |
The results of the lay user method comparison (cassette)
| Safecare device | Safecare device professional | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Layusers | Positive | 29 | 0 | 29 |
| Negative | 0 | 61 | 61 | |
| Total | 29 | 61 | 90 |
The results of the lay user method comparison (midstream, using dip method)
| Safecare device | Safecare device professional | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Layusers | Positive | 23 | 0 | 23 |
| Negative | 0 | 67 | 67 | |
| Total | 23 | 67 | 90 |
The results of the lay user method comparison (midstream, using the actual midstream method)
| Safecare device | Safecare device professional | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Layusers | Positive | 26 | 0 | 26 |
| Negative | 0 | 64 | 64 | |
| Total | 26 | 64 | 90 |
c. The performance tested by OTC user:
To evaluate its suitability to be used by the home use consumers (lay persons), spiked urine samples were tested by the lay persons and the results were compared with professional laboratory results. The results show that hCG Test Strip/cassette/midstream can be used by the untrained operator and get the correct results.
Results of performance tested by OTC user
| Masked spiked sample | |||
|---|---|---|---|
| Formats | Masked spiked sample | Masked spiked sampleProfessional users |
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Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China
| +(31.25mIU/ml) | -(18.75mIU/ml) | |||
|---|---|---|---|---|
| strip | Lay users | +(31.25mIU/ml) | 30 | 0 |
| -(18.75mIU/ml) | 0 | 30 | ||
| Cassette | Lay users | +(31.25mIU/ml) | 30 | 0 |
| -(18.75mIU/ml) | 0 | 30 | ||
| Midstream, using dipmethod | Lay users | +(31.25mIU/ml) | 30 | 0 |
| -(18.75mIU/ml) | 0 | 30 | ||
| Midstream, using thesimulated midstreammethod | Lay users | +(31.25mIU/ml) | 30 | 0 |
| -(18.75mIU/ml) | 0 | 30 |
After recording their results, participants were asked to evaluate the test. All participants thought the test was either "very easy" or "easy" to read and interpret (on a scale ranging from very difficult to very easy).
d. Matrix comparison: Not applicable.
- Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): 4. Clinical cut-off: 2SmIU/mL 5. Expected values/Reference range: Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. 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.