(273 days)
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas Link Technology Co., Ltd.'s One Step hCG Urine Pregnancy Test will be sold in three formats: Strip, Cassette, and Midstream. Each format of the device contains mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal antialpha-hCG antibodies (on test region) and goat anti-mouse IgG (on control region) are coated and immobilized on a membrane.
The Atlas One Step hCG Urine Pregnancy Test (Strip, Cassette, and Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The device is intended for over-the-counter use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various analytical performance characteristics. The primary acceptance criteria for a qualitative pregnancy test are generally high sensitivity at the claimed cut-off and high specificity (low false positives).
| Acceptance Criteria / Performance Metric | Reported Device Performance (Atlas One Step hCG Urine Pregnancy Test - Strip, Cassette, Midstream) |
|---|---|
| Sensitivity / Detection Limit | Needs to be clearly stated. The device sensitivity is 25 mIU/mL. |
| Percentage Positive at 25 mIU/mL hCG | Strip: 100% (120/120) |
| Cassette: 100% (120/120) | |
| Midstream: 100% (120/120) | |
| Percentage Negative at 0 mIU/mL hCG | Strip: 100% (120/120) |
| Cassette: 100% (120/120) | |
| Midstream: 100% (120/120) | |
| Cross-reactivity: LH (500 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Cross-reactivity: FSH (1000 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Cross-reactivity: TSH (1000 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Interference (various substances) | No interferences observed at specified concentrations |
| hCG ß-core fragment interference | No interference up to 1,000,000 pmol/mL (tested in 12.5mIU/mL and 30mIU/mL hCG samples) |
| Effect of urine pH | No interference within pH 3.0-10.0 |
| Specific Gravity | No interference within specific gravity 1.003-1.050 |
| High Dose Hook Effect | No hook effect up to 500,000 mIU/mL |
| Closed Pouch Real Time Stability | 36 months when stored at 2-30°C |
| Open Box Stability | Stable for up to 4 hours once opened (labeling recommends immediate testing) |
| Lay-user Interpretation Agreement | High agreement with professional interpretation (100% for positive and negative cases observed in the tables) |
2. Sample Size Used for the Test Set and Data Provenance
Analytical Performance (Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Detection Limit):
- Sample Size:
- Precision/Reproducibility: 40 urine samples for each concentration (0, 12.5, 16, 20, 25, 30, 40 mIU/mL hCG). These were tested with 3 batches of each of the three device formats (Strip, Cassette, Midstream). This means 40 samples * 7 concentrations * 3 batches * 3 formats = 2,520 individual tests, with 120 tests per concentration across all batches for each format.
- Cross-reactivity: Urine samples with 12.5 mIU/mL and 25 mIU/mL hCG, spiked with various concentrations of LH, FSH, TSH. Tested with 3 batches of each format. Specific number of samples per hormone concentration not explicitly stated but implies multiple tests.
- Interference (exogenous compounds): Normal non-pregnant urine (0 mIU/mL hCG) and 25 mIU/mL hCG samples spiked with 21 different interfering substances. Tested with 3 lots of each format. Specific number of tests per substance not detailed but implied multiple tests.
- hCG beta-core fragment: Urine samples with 12.5 mIU/mL and 30 mIU/mL hCG, spiked with 5 different concentrations of hCG ß-core fragment. Tested with 3 batches of each format.
- Urine pH: Urine samples with 0 mIU/mL and 25 mIU/mL hCG at 11 different pH values (3.0-10.0). Tested with 3 batches of each device.
- Specific Gravity: 0 mIU/mL and 25 mIU/mL hCG samples adjusted to specific gravities from 1.003-1.050. Tested with 3 lots of each format.
- Hook Effect: hCG-free urine spiked with 6 different high hCG concentrations (1,000 to 5,000,000 mIU/mL). Tested on three lots of devices for each format.
- Data Provenance: The document does not explicitly state the country of origin for the urine samples used in analytical studies. The device manufacturer is in China, so it's likely the studies were conducted there. These appear to be retrospective studies using spiked samples to evaluate analytical performance.
Method Comparison with Predicate Devices:
- Sample Size: 300 urine samples collected from women aged 18 to 45 (100 samples per device format: Strip, Cassette, Midstream). These samples were from non-pregnant, pregnant, or women with later periods/ready to be pregnant.
- Data Provenance: Samples collected from two different hospitals. The country of origin for these hospitals is not specified but is likely China, where the manufacturer is located. This study is prospective as samples were collected and then tested.
Lay-user Studies:
- Sample Size: 300 lay users, each testing their own urine with one test method (100 for Strip, 100 for Cassette, 100 for Midstream). Ages ranged from 18 to 45 years.
- Data Provenance: Not explicitly stated, but likely in China in connection with the hospitals mentioned in the professional method comparison. This is a prospective study involving direct user testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For Analytical Performance (Spiked Samples):
The ground truth was established by virtue of precisely spiking known concentrations of hCG and other substances into urine samples. No external experts were used to establish this ground truth; it was determined by the laboratory's preparation of the samples.
For Method Comparison with Predicate Devices:
The ground truth for the method comparison appears to be the predicate device's results, interpreted by a professional. The document states that "Results of the professional using the candidate device were compared to results obtained from the predicate device."
- Number of Experts: Not explicitly stated. It refers to "the professional," which could imply a single professional or multiple, but the number is not quantified.
- Qualifications of Experts: Not specified beyond "professional" or "laboratory professional."
For Lay-user Studies:
The ground truth was established by having a laboratory professional at the hospital interpret the same sample that the lay user tested.
- Number of Experts: Not explicitly stated. Refers to "a laboratory professional."
- Qualifications of Experts: Not specified beyond "laboratory professional."
4. Adjudication Method for the Test Set
For Analytical Performance (Spiked Samples):
No adjudication method was needed for the "ground truth" as it was based on known spiked concentrations. For the device's readings, "more than three operators" conducted the precision study. It is not stated how discrepancies among operators were resolved, but the results are presented as percentages positive/negative.
For Method Comparison with Predicate Devices:
The study design directly compares the candidate device's interpretation by a professional to the predicate device's results. It's a direct comparison against a "reference standard" (the predicate). No explicit adjudication method (like 2+1) is described for resolving conflicts between the candidate device results itself or between the candidate and predicate results. However, the tables implicitly assume concurrence between the professional's interpretation of the predicate device and the true clinical status.
For Lay-user Studies:
The lay user's interpretation was compared to the interpretation of the "candidate device professional." This implies the professional's reading served as the reference standard for evaluating the lay user's ability to interpret the device. No specific adjudication method is mentioned beyond this comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a traditional MRMC comparative effectiveness study, as typically understood in oncology or radiology (comparing human readers with AI assistance versus without AI assistance), was not explicitly performed.
The studies focused on:
- Analytical performance of the device itself.
- Method comparison of the candidate device (read by a professional) against a predicate device.
- Lay-user study comparing lay user interpretation against a professional's interpretation of the same candidate device.
There is no AI component in this device as it is a "visually-read, lateral flow immunoassay." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. Standalone Performance Study
Yes, a standalone performance study was clearly performed. The analytical performance section (Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Detection Limit, Hook Effect, Stability, etc.) describes the performance of the algorithm (in this case, the immunoassay device) only, without human interpretation being the primary variable. The results from these studies demonstrate the device's inherent capability to detect hCG at various concentrations and under different conditions.
7. Type of Ground Truth Used
- Analytical Performance: The ground truth was established through known concentrations of hCG (traceable to WHO 5th International Standard) in spiked urine samples. For interference studies, known concentrations of interfering substances were added.
- Method Comparison with Predicate Devices: The ground truth was the results obtained from the predicate device (K071930), as interpreted by a professional. This can be considered a "reference standard" within the context of substantial equivalence.
- Lay-user Studies: The ground truth for evaluating lay user performance was the interpretation of the candidate device by a "laboratory professional" using the same urine sample.
8. Sample Size for the Training Set
This submission describes a medical device (a pregnancy test kit) and its analytical and clinical performance studies, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The device relies on a chemical immunoassay, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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August 4, 2021
Atlas Link Technology Co., Ltd. Shuzhi Zang Regulatory Affairs Consultant Gu'an South Industry Zone Langfang, Hebei 065500 China
Re: K203246
Trade/Device Name: Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: October 30, 2020 Received: November 9, 2020
Dear Shuzhi Zang:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. 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:K203246
Device Name
Atlas One Step hCG Urine Pregnancy Test (Strip) Atlas One Step hCG Urine Pregnancy Test (Cassette) Atlas One Step hCG Urine Pregnancy Test (Midstream)
Indications for Use (Describe)
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K203246
August 02, 2021
A. 510(k) Submitter:
Atlas Link Technology Co., Ltd. Guan South Industry Zone, 065500 Langfang City Hebei Province, PEOPLE'S REPUBLIC OF CHINA
B. Submitter Contact:
Xiaoping Hao 86-10-8890 9113 sales@atlas-link.com
Designated Submission Correspondent:
Shuzhi Zang 617-595-3484 shuzhi.zang@gmail.com
C. Device
Trade Name: Atlas One Step hCG Urine Pregnancy Test (Strip) Atlas One Step hCG Urine Pregnancy Test (Cassette) Atlas One Step hCG Urine Pregnancy Test (Midstream)
Device Classification:
Class II, Human chorionic gonadotropin (HCG) test system (21 CFR 862.1155)
Product Code: LCX
D. Predicate:
BLUECROSS BIO-MEDICAL CO., LTD. One Step HCG Urine Pregnancy Test (Strip) (K071930) One Step HCG Urine Pregnancy Test (Cassette) (K071930) One Step HCG Urine Pregnancy Test (Midstream) (K071930).
E. Intended Use/Indications for Use:
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
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Atlas One Step hCG Urine Pregnancy Test Kit (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test Kit (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
F. Device Description:
Atlas Link Technology Co., Ltd.'s One Step hCG Urine Pregnancy Test will be sold in three formats: Strip, Cassette, and Midstream. Each format of the device contains mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal antialpha-hCG antibodies (on test region) and goat anti-mouse IgG (on control region) are coated and immobilized on a membrane.
G. Principle of Operation:
Atlas One Step Urine Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in early detection of pregnancy. The assay is based on an immunochromatographic technology. Each test device contains monoclonal anti-ß hCG antibody colloidal gold conjugate pre-dried on a pad. Monoclonal anti-a hCG antibodies (on the test region) and goat anti mouse IgG (on the control region) are coated and immobilized on a membrane. Other absorbent pads at the end of the assay absorb excess sample fluid. As the urine sample contacts the membrane, it dissolves the lyophilized conjugate. In a reactive sample, the hCG antigen will attach to the anit-BhCG monoclonal antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti- ahCG monoclonal antibody affixed on the test zone ("T") will bind the HCG-gold conjugate complex, forming a pink line. In addition, all samples will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of the polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates sufficient sample volume was added.
H. Technological Characteristics:
Atlas One Step hCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream) are compared with the predicate device BLUECROSS BIO-MEDICAL CO., LTD.'s One Step HCG Urine Pregnancy Test (Strip, Cassette, Midstream) (K071930). The product characteristics are shown below in the Comparison Tables:
Table 1: General Comparison Table
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| Item(s) | Subject Device(K203246) | Predicate Device(K071930) | Comparison |
|---|---|---|---|
| IntendedUse/Indications forUse | It is a visually-read, lateralflow immunoassay for thequalitative detection ofhuman chorionicgonadotropin (hCG) in theurine to help in the earlydetection of pregnancy byvisual. The device isdesigned for over-the-counter use only.Additional clinicalexamination should beperformed to confirm thepregnancy. The device issingle use. | It is a visually-read, lateralflow immunoassay for thequalitative detection ofhuman chorionicgonadotropin (hCG) in theurine to help in the earlydetection of pregnancy byvisual. The device isdesigned for over-the-counter use as well asprofessional use.Additional clinicalexamination should beperformed to confirm thepregnancy. | Similar |
| Specimen | Urine | Urine | Same |
| Technology | Lateral Flow Immunoassay | Lateral Flow Immunoassay | Same |
| Detection Limit | 25 mIU/mL | 25 mIU/mL | Same |
| Format | Strip, Cassette, Midstream | Strip, Cassette, Midstream | Same |
| Read Time | 5-10 minutes | Not available from the510(k) Summary document | Different |
| High Dosage HookEffect | No hook effect up to500,000 mIU/mL | No hook effect up to250,000 mIU/mL | Same |
| Specificity | No interference for urinewith specific gravity from1.003-1.050 | Not available from thepublic information | Different |
| pH Interference | No interference for urinewith pH 3-10 | No interference for urinewith pH 4-9 | Different |
| Specific GravityInterference | No interference for urinewith specific gravity from1.003-1.050 | Not available from the510(k) Summary document | Different |
I. Standards/Guidance Documents Referenced:
FDA Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, dated July 22, 2000.
J. Performance Characteristics (if/when applicable):
a. Analytical Performance:
1. Precision/Reproducibility:
Precision studies were performed for the Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), and Atlas One Step hCG Urine Pregnancy Test (Midstream)(stimulated midstream method only) using 40 urine samples
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collected from non-pregnant females spiked with hCG traceable to the WHO 5th International Standard (IS) for each batch. Samples created had concentrations of 0mIU/mL, 12.5mIU/mL, 16mIU/mL, 25mIU/mL, 30mIU/mL, 40mIU/mL. Samples were masked and randomized prior to testing. The study was conducted over 5 days by more than three operators. Three batches of each of the three device formats were tested. The midstream format was tested with the simulated midstream method.
| Conc. of | Batch20190501 | Batch D0501 | Batch 2019-05-07 | Total result | %Positive | %Negative | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| hCG | + | - | + | - | + | - | + | - | ve | ve |
| 40 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 30 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 25mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 20 mIU/mL | 23 | 17 | 25 | 15 | 23 | 17 | 71 | 49 | 59 | 41 |
| 16 mIU/mL | 0 | 40 | 0 | 40 | 3 | 37 | 3 | 117 | 2.5 | 97.5 |
| 12.5mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
| 0 mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
Results for the One Step hCG Urine Pregnancy Test Strip
Results for the One Step hCG Urine Pregnancy Test Cassette
| Conc. of hCG | Batch A0501 | BatchBCP190301 | Batch 20190301HC | Total result | %Positive | %Negative | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | - | ve | ve | |
| 40 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 30 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 25mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 20 mIU/mL | 23 | 17 | 22 | 18 | 22 | 18 | 67 | 53 | 56 | 44 |
| 16 mIU/mL | 2 | 38 | 2 | 38 | 3 | 37 | 7 | 113 | 5.8 | 94.2 |
| 12.5mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
| 0 mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
Results for the One Step hCG Urine Pregnancy Test Midstream (Stimulated method only)
| Conc. of hCG | BatchHCG190501 | BatchHCG190401 | Batch 190403 | Total result | %Positive | %Negative | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | - | ve | ve | |
| 40 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 30 mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
| 25mIU/mL | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 | 0 |
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| 20 mIU/mL | 20 | 20 | 20 | 20 | 21 | 19 | 61 | 53 | 50.8 | 49.2 |
|---|---|---|---|---|---|---|---|---|---|---|
| 16 mIU/mL | 2 | 38 | 1 | 39 | 3 | 37 | 6 | 114 | 5 | 95 |
| 12.5mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
| 0 mIU/mL | 0 | 40 | 0 | 40 | 0 | 40 | 0 | 120 | 0 | 100 |
2. Linearity:
Linearity is not applicable since this is a qualitative test.
3. Analytical Specificity/Interference:
Cross-relativity:
To evaluate cross-reactivity for the Atlas One Step hCG Urine Pregnancy Test Strip, Atlas One Step hCG Urine Pregnancy Test Cassette, and Atlas One Step hCG Urine Pregnancy Test Midstream, urine samples with hCG level (12.5mIU/mL) and urine samples with hCG level (25mIU/mL) were spiked with various concentrations of glycoprotein hormones, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Thyroid Stimulating Hormone (TSH). These samples were tested 3 batches of each format of the device.
The results demonstrated there is no interference from the tested glycoprotein hormones up to 500 mIU/mL LH, 1000mIU/mL FSH, and 1000 mIU/mL TSH in either 12.5mIU/mL hCG urine samples or in 25mIU/mL hCG urine samples.
Interference:
To evaluate the potential for interference by certain exogenous compounds and potentially interfering clinical conditions, the substances listed were prepared by diluting stock interference material to the desired concentration. Normal, nonpregnant female urine specimens containing 0 and 25 mIU/mL hCG were spiked with the interferences to obtain the desired test concentration. Three lots of each format were tested.
The results showed that no interferences were observed from substance at the following concentrations for both negative and positive hCG urine samples.
| Interfering substances | Substances concentration |
|---|---|
| Acetaminophen | 20 mg/dl |
| Aspirin | 20 mg/dl |
| Ascorbic acid | 20 mg/dl |
| Caffeine | 20 mg/dl |
| Gentisic acid | 20 mg/dl |
| Glucose | 200 mg/dl |
| Phenylpropanolamine | 20 mg/dl |
| Hemoglobin | 1mg mg/dl |
| Salicylic acid | 20 mg/dl |
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| Thiophene | 20 mg/dl |
|---|---|
| Tetracycline | 20 mg/dl |
| Ampicillin | 200mg/dl |
| Albumin | 2000 mg/dl |
| Bilirubin | 2 mg/ml |
| Erythrocytes | 250 /μl |
| Leukocyte | 500/ μl |
| Uric acid | 450 mmol/l |
| Ketone | 80 mg/dl |
| Ethanol | 1% |
| Atropine | 20 mg/dl |
| Benzoylecgonine | 10 mg/dl |
| Cannabinol | 10 mg/dl |
| EDTA | 80 mg/dl |
| Methanol | 1% |
Effect of hCG beta-core fragment:
To evaluate potential interference by hCG ß-core fragment for the Atlas One Step hCG Urine Pregnancy Test Strip. Atlas One Step hCG Urine Pregnancy Test Cassette. Atlas One Step hCG Urine Pregnancy Test Midstream devices, one group urine samples with 12.5mIU/mL hCG (below the 25mIU/mL cut-off level) and another group urine samples with 30mIU/mL (above the 25mIU/mL cut-off level) hCG were spiked with the hCG ß core fragment (traceable to WHO reference reagent 99/708) to yield samples with concentrations of 50,000 pmol/mL, 125,000 pmol/mL, 250,000 pmol/mL, 500,000 pmol/mL, 1,000,000 pmol/mL. These samples were tested with 3 batches of each format of the device. The data obtained demonstrated that there is no interference by hCG ß -core fragment at the concentrations tested.
Effect of urine pH:
To evaluate potential interference from changes in urine pH for the Atlas One Step hCG Urine Pregnancy Test Strip, Atlas One Step hCG Urine Pregnancy Test Cassette, Atlas One Step hCG Urine Pregnancy Test Midstream devices, urine samples containing 0mIU/mL and 25mIU/mL hCG were tested with 3 batches of each device using samples at pH values of 3.0. 3.5. 4.0. 5.0. 6.0. 7.0. 8.0. 8.5. 9.0. 9.5. 10.0. The results demonstrated that samples within the pH range of 3.0-10.0 do not interfere with either positive or negative results from the device.
Specific Gravity:
Negative urine specimen containing 0 mIU/mL hCG and urine specimen with hCG 25mIU/mL were adjusted to specific gravities from 1.003-1.050. Three lots of each
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format of the devices were test. The results showed that no interference in samples with specific gravity ranging from 1.003-1.050.
Hook effect study:
To evaluate high dose hook effect, hCG-free urine specimens spiked with hCG at 1,000mIU/mL, 10,000mIU/mL, 100,000mIU/mL, 500,000mIU/mL, 1,000,000mIU/mL, and 5,000,000 mIU/mL were tested on three lots of devices for each format. The results showed no hook effect up to 500,000 mIU/mL
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- Assay Reportable Range:
Not applicable. This is a qualitative test.
- Assay Reportable Range:
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- Traceability and Stability
Traceability:
- Traceability and Stability
The One Step hCG Urine Pregnancy Test Kit (Strip), One Step hCG Urine Pregnancy Test Kit (Cassette), One Step hCG Urine Pregnancy Test Kit (Midstream) are traceable to the WHO 5th IS material.
Closed Pouch Real Time Stability:
Closed pouch real time stability studies were performed separately on three lots of each format - test strips, cassette, and midstream. The test kits are stored at 2-8°C, and 25-30°C after production. Test kits are from those products that were manufactured between January 2017 and May 2017. The first testing was at late May, 2017. Urine samples will be tested every 6 month for the subject devices in all three formats in the first 30 months at 2-8°C, and 25-30°C environment; then more subject devices are tested every 3 months for the remaining 9-month period for hCG at 4 concentrations around the cutoff. Based on these studies, closed pouch stability is 36 months when stored at 2-30°C .
Open Box Stability:
Open box studies were performed over 5 days at 25-30°C and ≥ 85% relative humidity for various concentrations of hCG. Based on these studies, the device was stable for up to 4 hours once opened, however, labeling recommends that testing take place immediately after opening the box.
6. Detection Limit
Refer to the Precision and Reproducibility section above for additional information. The sensitivity of the One Step hCG Urine Pregnancy Test Kit (Strip), One Step hCG Urine Pregnancy Test Kit (Cassette), One Step hCG Urine Pregnancy Test Kit (Midstream) are 25 mIU/mL.
7. Assay Cut-Off:
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The sensitivity of the One Step hCG Urine Pregnancy Test Kit (Strip), One Step hCG Urine Pregnancy Test Kit (Cassette), One Step hCG Urine Pregnancy Test Kit (Midstream) are 25 mIU/mL.
K. Comparison Studies
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- Method Comparison with Predicate Devices:
Urine samples were collected from 300 women at two different hospitals. These samples were collected from women between the ages of 18 to 45 who were nonpregnant, were pregnant, experienced later periods or were ready to be pregnant. 100 samples were tested per each format of the devices. Samples were randomly collected at various times throughout the day and were masked and randomized prior to testing. Results of the professional using the candidate device were compared to results obtained from the predicate device. Summary of results is presented in the table below:
- Method Comparison with Predicate Devices:
| Candidate Device | Predicate device Positive | Predicate device Negative |
|---|---|---|
| Hospital A | 22 (a) | 0 (b) |
| Hospital A | 0 (c) | 28 (d) |
| Hospital B | 19 (a) | 0 (b) |
| Hospital B | 0 (c) | 31 (d) |
The results of professional method comparison (Strip format)
The results of professional method comparison (Cassette format)
| Candidate Device | Predicate device Positive | Predicate device Negative |
|---|---|---|
| Hospital A Positive | 14 (a) | 0 (b) |
| Hospital A Negative | 0 (c) | 36 (d) |
| Hospital B Positive | 18 (a) | 0 (b) |
| Hospital B Negative | 0 (c) | 32 (d) |
The results of professional method comparison (Midstream format, stimulated method only)
| Candidate Device | Predicate device Positive | Predicate device Negative | |
|---|---|---|---|
| Hospital A | Positive | 19 (a) | 0 (b) |
| Negative | 0 (c) | 31 (d) | |
| Hospital B | Positive | 18 (a) | 0 (b) |
| Negative | 0 (c) | 32 (d) |
2. Matrix Comparison
Not Applicable. The device is intended for urine samples only.
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L. Clinical Studies
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- Clinical Sensitivity: Not Applicable.
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- Clinical Specificity: Not Applicable.
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- Lay-user Studies:
A lay-user study was conducted with 300 lay users. Each subject tested their own urine with only one test method on the candidate device following the instructions on the package insert. Then the results of their test were compared to results reported by a laboratory professional at the hospital. The same sample was tested by a healthcare professional using the predicate device. This included 100 lay users using test strip, 100 using test cassette, 100 using test midstream with midstream method. Subject ages ranged from 18 to 45 years. All samples were masked and randomized prior to professional testing. Summary of results is presented in the table below:
Results of the lay user method comparison for the One Step hCG Urine Pregnancy Test (Strip)
| Candidate Device LayUser | Candidate DeviceProfessional Positive | Candidate DeviceProfessional Negative | Total | |
|---|---|---|---|---|
| Hospital A | Positive | 22 (a) | 0 (b) | 22 |
| Negative | 0 (c) | 28 (d) | 28 | |
| Hospital B | Positive | 19 (a) | 0 (b) | 19 |
| Negative | 0 (c) | 31 (d) | 31 | |
| Total | 41 | 59 | 100 |
Results of the lay user method comparison for the One Step hCG Urine Pregnancy Test (Cassette)
| Candidate Device Lay | Candidate DeviceProfessional Positive | Candidate DeviceProfessional Negative | Total | |
|---|---|---|---|---|
| User | ||||
| Hospital A | Positive | 14 (a) | 0 (b) | 14 |
| Negative | 0 (c) | 36 (d) | 36 | |
| Hospital B | Positive | 18 (a) | 0 (b) | 18 |
| Negative | 0 (c) | 32 (d) | 32 | |
| Total | 32 | 68 | 100 |
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| Candidate Device LayUser | Candidate DeviceProfessional Positive | Candidate DeviceProfessional Negative | Total | |
|---|---|---|---|---|
| Hospital A | Positive | 19 (a) | 0 (b) | 19 |
| Negative | 0 (c) | 31 (d) | 31 | |
| Hospital B | Positive | 18 (a) | 0 (b) | 18 |
| Negative | 0 (c) | 32 (d) | 32 | |
| Total | 37 | 63 | 100 |
Results of the lay user method comparison for the One Step hCG Urine Pregnancy Test (Midstream)
M. Conclusion
The submitted information in this premarket notification 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.