(273 days)
Not Found
No
The device is a visually-read lateral flow immunoassay. The description and performance studies focus on the chemical and biological components and their interaction with hCG, with no mention of computational analysis, image processing, or AI/ML algorithms for result interpretation.
No
Explanation: The device is a diagnostic test for pregnancy, not a device used to provide therapy or treatment.
Yes
This device is a qualitative immunoassay designed to detect human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This falls under the definition of a diagnostic device as it is used to identify a medical condition (pregnancy).
No
The device is a lateral flow immunoassay, which is a physical test strip or cassette that detects hCG in urine. The description details the physical components and chemical reactions involved, indicating it is a hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy." This is a diagnostic purpose performed in vitro (outside the body) using a biological sample (urine).
- Device Description: The description details the components and mechanism of the test, which is a "visually-read, lateral flow immunoassay." This is a common format for IVD tests.
- Sample Type: The test uses urine, which is a biological specimen.
- Performance Studies: The document describes various analytical and clinical performance studies conducted to validate the device's accuracy and reliability for its intended diagnostic use. These types of studies are standard for IVD devices.
- Predicate Device: The mention of predicate devices (K071930) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
Therefore, based on the provided information, the Atlas One Step hCG Urine Pregnancy Test (in all three formats) clearly fits the definition of an In Vitro Diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Study Type: Precision/Reproducibility studies.
Sample Size: 40 urine samples for each batch of each device format (total 120 samples per concentration level, per format) collected from non-pregnant females spiked with hCG. Samples were masked and randomized prior to testing.
Data Source: Urine samples from non-pregnant females.
Key Results:
- For One Step hCG Urine Pregnancy Test Strip: 100% positive agreement for 25 mIU/mL, 30 mIU/mL, and 40 mIU/mL hCG; 59% positive agreement for 20 mIU/mL hCG; 2.5% positive agreement for 16 mIU/mL hCG; 0% positive agreement for 12.5 mIU/mL and 0 mIU/mL hCG.
- For One Step hCG Urine Pregnancy Test Cassette: 100% positive agreement for 25 mIU/mL, 30 mIU/mL, and 40 mIU/mL hCG; 56% positive agreement for 20 mIU/mL hCG; 5.8% positive agreement for 16 mIU/mL hCG; 0% positive agreement for 12.5 mIU/mL and 0 mIU/mL hCG.
- For One Step hCG Urine Pregnancy Test Midstream (Stimulated method only): 100% positive agreement for 25 mIU/mL, 30 mIU/mL, and 40 mIU/mL hCG; 50.8% positive agreement for 20 mIU/mL hCG; 5% positive agreement for 16 mIU/mL hCG; 0% positive agreement for 12.5 mIU/mL and 0 mIU/mL hCG.
Analytical Specificity/Interference:
Study Type: Cross-reactivity and Interference studies.
Sample Size: Urine samples with hCG levels of 12.5mIU/mL and 25mIU/mL spiked with various substances.
Data Source: Urine samples.
Key Results:
- No interference from glycoprotein hormones (LH up to 500 mIU/mL, FSH up to 1000mIU/mL, TSH up to 1000 mIU/mL).
- No interference observed from various substances (e.g., Acetaminophen, Aspirin, Ascorbic acid, Caffeine, Glucose, Hemoglobin, etc.) at specified concentrations.
- No interference by hCG ß-core fragment at tested concentrations (50,000 pmol/mL up to 1,000,000 pmol/mL).
- No interference from changes in urine pH within the range of 3.0-10.0.
- No interference in samples with specific gravity ranging from 1.003-1.050.
- No hook effect up to 500,000 mIU/mL.
Method Comparison with Predicate Devices (Professional Use):
Study Type: Method Comparison.
Sample Size: 300 urine samples (100 samples per format).
Data Source: Urine collected from 300 women (ages 18-45) from two hospitals. Samples were randomly collected, masked, and randomized.
Key Results:
- For Strip format: Both Hospital A and Hospital B showed 100% agreement with the predicate device (22 positive, 28 negative for Hospital A; 19 positive, 31 negative for Hospital B).
- For Cassette format: Both Hospital A and Hospital B showed 100% agreement with the predicate device (14 positive, 36 negative for Hospital A; 18 positive, 32 negative for Hospital B).
- For Midstream format: Both Hospital A and Hospital B showed 100% agreement with the predicate device (19 positive, 31 negative for Hospital A; 18 positive, 32 negative for Hospital B).
Lay-user Studies:
Study Type: Lay-user study.
Sample Size: 300 lay users (100 per test method/format).
Data Source: Lay users tested their own urine with the candidate device following instructions. Results were compared to those reported by a laboratory professional using the candidate device, and the same sample was tested by a healthcare professional using the predicate device.
Key Results:
- For Strip format: Total 41 professional positive, 59 professional negative; lay user results showed 100% agreement with professional results for both positive and negative (e.g., Hospital A: 22 positive, 28 negative confirmed by lay user).
- For Cassette format: Total 32 professional positive, 68 professional negative; lay user results showed 100% agreement with professional results for both positive and negative (e.g., Hospital A: 14 positive, 36 negative confirmed by lay user).
- For Midstream format: Total 37 professional positive, 63 professional negative; lay user results showed 100% agreement with professional results for both positive and negative (e.g., Hospital A: 19 positive, 31 negative confirmed by lay user).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
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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.
1
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
2
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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3
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.
4
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 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended
Use/Indications for
Use | It 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 by
visual. 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. | It 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 by
visual. The device is
designed for over-the-
counter use as well as
professional use.
Additional clinical
examination should be
performed to confirm the
pregnancy. | 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 the
510(k) Summary document | Different |
| High Dosage Hook
Effect | No hook effect up to
500,000 mIU/mL | No hook effect up to
250,000 mIU/mL | Same |
| Specificity | No interference for urine
with specific gravity from
1.003-1.050 | Not available from the
public information | Different |
| pH Interference | No interference for urine
with pH 3-10 | No interference for urine
with pH 4-9 | Different |
| Specific Gravity
Interference | No interference for urine
with specific gravity from
1.003-1.050 | Not available from the
510(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
6
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 | Batch
20190501 | | 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 | | Batch
BCP190301 | | 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 | Batch
HCG190501 | | Batch
HCG190401 | | 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 Lay
User | | Candidate Device
Professional Positive | Candidate Device
Professional 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 Device
Professional Positive | Candidate Device
Professional 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 Lay
User | | Candidate Device
Professional Positive | Candidate Device
Professional 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.