(494 days)
Not Found
No
The device description and performance studies focus on a standard immunochromatographic assay and display results on an LCD. There is no mention of AI, ML, image processing, or complex algorithms beyond interpreting the lateral flow test strip.
No.
This device is an immunoassay for the detection of hCG in urine, intended as an aid in the early detection of pregnancy. It does not provide any treatment or therapy.
Yes
The device qualitatively detects human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a specific physiological condition.
No
The device description clearly states it is a "digital pregnancy test" that employs an "immunochromatographic sandwich assay on a lateral flow test strip" and displays results on an "LCD". These are all hardware components, indicating it is not a software-only 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 urine." Detecting substances in bodily fluids to aid in diagnosis (in this case, pregnancy) is a core function of IVDs.
- Device Description: The description details an "over-the-counter (OTC), digital pregnancy test" that "employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip." This describes a test performed in vitro (outside the body) on a biological sample (urine).
- Performance Studies: The document details numerous performance studies, including analytical performance (precision, specificity), comparison studies with a predicate device, and clinical studies using urine samples. These types of studies are required for IVDs to demonstrate their accuracy and reliability.
- Regulatory Context: The mention of a "Predicate Device(s)" with a K number (K123567) strongly indicates that this device is being submitted for regulatory clearance as an IVD, likely through the 510(k) pathway in the US.
In summary, the Clearblue® Early Digital Pregnancy Test meets the definition of an In Vitro Diagnostic device because it is intended for the examination of a specimen derived from the human body (urine) to provide information for the diagnosis of a condition (pregnancy).
N/A
Intended Use / Indications for Use
The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The Clearblue® Early Digital Pregnancy Test is an over-the-counter (OTC), digital pregnancy test with sensitivity to 10mIU/ml hCG (hormone human chorionic gonadotrophin) and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The result is displayed to the user, in words, on an LCD.
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
home 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)
1. Analytical Performance
- Precision/Reproducibility: A pooled negative urine was spiked with hCG to provide nine urine standards with hCG concentrations of 0, 3, 4.5, 6, 7.5, 9, 10, 12.5 and 25 mIU/ml. The nine standards were each tested with devices from three different batches using both dip and simulated in-stream sampling methods. Three technicians performed the study over three non-consecutive days, each testing 5 devices per batch, per standard, per sampling method. The analytical sensitivity was determined to be 10 mIU/ml, and the analytical cut-off was 7.6 mIU/ml.
- High dose hook effect study: Negative pooled urine was spiked with hCG to concentrations of Specificity 100.0%
- Peri-menopausal: 150 Not Pregnant (n) / 150 Samples (n) -> Specificity 100.0%
- Post-menopausal: 149 Not Pregnant (n) / 150 Samples (n) -> Specificity 99.3%
- All Not Pregnant: 449 Not Pregnant (n) / 450 Samples (n) -> Specificity 99.8%
- One sample from the post-menopausal cohort with 7.83 mIU/ml hCG (higher than analytical cut-off) gave a positive result.
- Lay User Spiked Standard Study: Lay users tested a range of hCG urine standards (3, 7.5, 8.5, 10 mIU/ml) by both dip and in-stream sampling methods.
- hCG standard 3 mIU/ml: Total 200 (n), 0 (Pregnant n), 0% (Pregnant %)
- hCG standard 7.5 mIU/ml: Total 200 (n), 100 (Pregnant n), 50% (Pregnant %)
- hCG standard 8.5 mIU/ml: Total 200 (n), 148 (Pregnant n), 74% (Pregnant %)
- hCG standard 10 mIU/ml: Total 200 (n), 200 (Pregnant n), 100% (Pregnant %)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: 10mIU/ml
Analytical cut-off: 7.6 mIU/ml
Lay user study: PPV, NPV, sensitivity, specificity and accuracy for the Clearblue® Early Detection Pregnancy Test in the hands of lay-user volunteers was 100%, for both dip and in-stream testing methods.
Specificity study for false-positive rate:
Pre-menopausal: 100.0%
Peri-menopausal: 100.0%
Post-menopausal: 99.3%
All Not Pregnant: 99.8%
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.
K123567, FIRST RESPONSE™ Gold Digital Pregnancy Test (K123567)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
August 13, 2021
SPD Swiss Precision Diagnostics GmbH % Kamila Przedmojska Senior Regulatory Affairs Specialist SPD Development Company Limited Priory Business Park Bedford MK44 3UP United Kingdom
Re: K200913
Trade/Device Name: Clearblue® Early Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: November 4, 2020 Received: November 6, 2020
Dear Kamila Przedmojska:
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 (if known) K200913
Device Name Clearblue® Early Digital Pregnancy Test
Indications for Use (Describe)
The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Swiss Precision Diagnostics GmbH. The logo consists of the letters SPD in a stylized font, with the letters arranged in a circular shape. The letters are white, and the circle is a gradient of blue and green. The text "Swiss Precision Diagnostics GmbH" is located to the right of the logo.
510(k) Summary
| A. Submitted By: | SPD Swiss Precision Diagnostics GmbH 47 Route de Saint-Georges Petit-Lancy CH-1213 Geneva Switzerland Telephone: +41 580048741 |
|---|---|
| B. Contact Person: | Kamila Przedmojska Senior Regulatory Affairs Specialist SPD Development Company Limited Priory Business Park Bedford MK44 3UP United Kingdom Telephone: +44 1234835504 |
| C. Date Prepared: | 11 August, 2021 |
| D. Device Name: | Clearblue® Early Digital Pregnancy Test |
| Product Code: | LCX |
| Common name: | Kit, Test, Pregnancy, hCG, over the counter |
| Classification: | Class II |
| Product code: | LCX |
| Regulation Description: | Human chorionic gonadotropin (hCG) test system |
| Regulation number: | 21CFR 862.1155 |
| E. Predicate Device: | K123567, FIRST RESPONSE™ Gold Digital Pregnancy Test (K123567) |
4
F. Indication for Use
The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
G. Device Description
The Clearblue® Early Digital Pregnancy Test is an over-the-counter (OTC), digital pregnancy test with sensitivity to 10mIU/ml hCG (hormone human chorionic gonadotrophin) and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The result is displayed to the user, in words, on an LCD.
H. Substantial Equivalence Information
Predicate device name: FIRST RESPONSE™ Gold Digital Pregnancy Test
Predicate (k) number: K123567
Comparison with predicate:
Table 1 Similarities and differences between Clearblue® Early Detection Pregnancy Test and the predicate FIRST RESPONSE™ Early Results Pregnancy Test
| Component | Clearblue® Early Digital
Pregnancy
(Proposed Device) | FIRST RESPONSE™ Gold
Digital Pregnancy Test
(Predicate Device) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Similarities | | |
| Intended
Use | Qualitative detection of
human hCG for an aid in
early detection of pregnancy | Same |
| Component | Clearblue® Early Digital
Pregnancy
(Proposed Device) | FIRST RESPONSE™ Gold
Digital Pregnancy Test
(Predicate Device) |
| Target User | Over-The-Counter use | Same |
| Device
format | Single Use | Same |
| Sample
Matrix | Urine | Same |
| Analyte | hCG | Same |
| hCG
Sensitivity | 10mIU/ml | Same |
| Traceability | WHO 4th International
Standard for hCG | Same |
| Test
Principle | Lateral flow qualitative
chromatographic
immunoassay with digital
result display | Same |
| Electronic
components | Microprocessor with specific
circuitry and algorithm. LCD
readout with battery as
power source. | Same |
| Sample
application | In-stream and dip methods | Same |
| Early Claim | Pregnancy can be detected
as early as six days before
the date of the missed
period (five days before
expected period). | Same |
| | Differences | |
| hCG
Isoforms
Detected | Intact hCG | Intact hCG
Hyperglycosylated hCG
hCG β-subunit
hCG β-core fragment |
| Sampling
time | The user is instructed to
remove the absorbent tip
from the urine when the
Stop Light begins to flash
(usually 5 seconds for both
sampling methods) | 5 seconds for both sampling
methods |
| Component | Clearblue® Early Digital
Pregnancy
(Proposed Device) | FIRST RESPONSE™ Gold
Digital Pregnancy Test
(Predicate Device) |
| Time to
results | 1 -5 minutes | 3 minutes |
| Result
Display | Pregnant / Not Pregnant
displayed in words | YES+ (for Pregnant results)
NO- (for Not Pregnant result) |
5
6
I. Test Principle
The Clearblue® Early Digital Pregnancy test is a lateral flow sandwich immunoassay employing monoclonal antibodies that are specifically directed against the alpha and beta sub-units of hCG.
To use the test, the user either urinates directly onto the absorbent wick or collects a sample in a container and dips the absorbent wick into the collected sample until the Stop Light begins to flash (which usually takes 5 seconds for both sampling methods). Once the device self-calibration process is completed, a progress bar symbol appears on the display, indicating that test is working and counting down the time to result. The test is complete after a result (Pregnant/ Not Pregnant in words) or an error (book symbol) is displayed on the LCD. This occurs within 1-5 minutes of sample detection.
J. Performance characteristics
1. Analytical Performance
a) Precision/Reproducibility
A pooled negative urine was spiked with hCG to provide nine urine standards with the hCG concentrations of 0, 3, 4.5, 6, 7.5, 9, 10, 12.5 and 25 mIU/ml. The nine standards were each tested with devices from three different batches using both dip and simulated in-stream sampling methods.
The study was performed by three technicians over three non-consecutive days. On each test day, 3 technicians tested 5 devices each per batch, per standards, per sampling method.
The results demonstrate that the analytical sensitivity of the Clearblue® Early Digital Pregnancy Test device is 10mIU/ml. The analytical cut-off
7
value (approximately half of the devices yield positive results and the remainder yield negative) has been determined as 7.6 mIU/ml.
The results are summarised in the tables below:
Overall Precision Results of Clearblue® Early Digital Pregnancy Test
| hCG
Standard
(mIU/
ml) | Total
Samples
(n) | Clearblue® Early Digital Pregnancy Test Overall Results | | | | | | Total
Pregnant
(%) |
|---------------------------------|-------------------------|---------------------------------------------------------|-----------------|----------------------------|----------------------------|-----------------|----------------------------|--------------------------|
| | | Dip method | | | Simulated in stream method | | | |
| | | Not
Pregnant
(n) | Pregnant
(n) | Pregnant
Results
(%) | Not
Pregnant
(n) | Pregnant
(n) | Pregnant
Results
(%) | |
| 0 | 324 | 162 | 0 | 0.0 | 162 | 0 | 0.0 | 0.0 |
| 3 | 324 | 162 | 0 | 0.0 | 162 | 0 | 0.0 | 0.0 |
| 4.5 | 324 | 159 | 3 | 1.9 | 155 | 7 | 4.3 | 3.1 |
| 6 | 324 | 147 | 15 | 9.3 | 141 | 21 | 13.0 | 11.1 |
| 7.5 | 324 | 106 | 56 | 34.6 | 88 | 74 | 45.7 | 40.1 |
| 9 | 324 | 21 | 141 | 87.0 | 15 | 147 | 90.7 | 88.9 |
| 10 | 324 | 0 | 162 | 100.0 | 0 | 162 | 100.0 | 100.0 |
| 12.5 | 324 | 0 | 162 | 100.0 | 0 | 162 | 100.0 | 100.0 |
| 25 | 324 | 0 | 162 | 100.0 | 0 | 162 | 100.0 | 100.0 |
Percentage Pregnant Results for Each hCG Standard by Technician
| hCG
Standard
(mIU/
| ml) | Technician 1 | Technician 2 | Technician 3 | |||
|---|---|---|---|---|---|---|
| P/NP* | ||||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | ||||||
| 0 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 3 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 4.5 | 1/107 | 0.9 | 5/103 | 4.6 | 4/104 | 3.7 |
| 6 | 11/97 | 10.2 | 12/96 | 11.1 | 13/95 | 12.0 |
| 7.5 | 37/71 | 34.3 | 49/59 | 45.4 | 44/64 | 40.7 |
| 9 | 97/11 | 89.8 | 95/13 | 88.0 | 96/12 | 88.9 |
| 10 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 12.5 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 25 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
*Pregnant/Not Pregnant Results
8
| Hcg
Standard
(Miu/
| ml) | Day 1 | Day 2 | Day 3 | |||
|---|---|---|---|---|---|---|
| P/NP* | ||||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | ||||||
| 0 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 3 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 4.5 | 2/106 | 1.9 | 3/105 | 2.8 | 5/103 | 4.6 |
| 6 | 14/94 | 13.0 | 7/101 | 6.5 | 15/93 | 13.9 |
| 7.5 | 37/71 | 34.3 | 45/63 | 41.7 | 48/60 | 44.4 |
| 9 | 96/12 | 88.9 | 95/13 | 88.0 | 97/11 | 89.8 |
| 10 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 12.5 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 25 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
Percentage Pregnant Results for each hCG standard by Day
*Pregnant/Not Pregnant Results
| NEN0008/1R | NEN0008/2R | NEN0008/3 | ||||
|---|---|---|---|---|---|---|
| hCG | ||||||
| Standard | ||||||
| (mIU / | ||||||
| ml) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | P/NP* | |||||
| (n) | Pregnant | |||||
| Results | ||||||
| (%) | ||||||
| 0 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 3 | 0/108 | 0.0 | 0/108 | 0.0 | 0/108 | 0.0 |
| 4.5 | 3/105 | 2.8 | 5/103 | 4.6 | 2/106 | 1.9 |
| 6 | 15/93 | 13.9 | 11/97 | 10.2 | 10/98 | 9.3 |
| 7.5 | 53/55 | 49.1 | 38/70 | 35.2 | 39/69 | 36.1 |
| 9 | 97/11 | 89.8 | 98/10 | 90.7 | 93/15 | 86.1 |
| 10 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 12.5 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
| 25 | 108/0 | 100.0 | 108/0 | 100.0 | 108/0 | 100.0 |
*Pregnant/Not Pregnant Results
b) Linearity/assay reportable range:
Not applicable. This is a qualitative device.
9
c) High dose hook effect study:
Negative pooled urine was spiked with hCG to concentrations of 55 years). 150 urine samples were collected from individual women of each cohort. All 450 urine samples were tested by technicians with three batches of the Clearblue® Early Digital Pregnancy Test devices by dip method of sampling.
| Cohort | Not Pregnant (n) | Samples (n) | Specificity (%) |
|---|---|---|---|
| Pre-menopausal | 150 | 150 | 100.0 |
| Peri-menopausal | 150 | 150 | 100.0 |
| Post-menopausal | 149 | 150 | 99.3 |
| All Not Pregnant | 449 | 450 | 99.8 |
The results are summarised in table below:
There was 1 sample from the post-menopausal cohort with a raised hCG concentration that gave a positive result. The hCG concentration of this sample was determined as 7.83 mIU/ml, which is higher than the analytical cut-off of the device.
Lay User Spiked Standard Study
A study was performed to analyse the performance of the Clearblue® Early Digital Pregnancy Test, when read by lay users according to the Instruction for Use. A range of hCG urine standards at 3, 7.5, 8.5, 10 mIU/ml were tested by volunteers representing lay users by both dip and in-stream sampling method.
The overall results when tested by lay users are summarised in table below:
| hCG standard
(mIU/ml) | Total
(n) | Pregnant
(n) | Pregnant
(%) |
|--------------------------|--------------|-----------------|-----------------|
| 3 | 200 | 0 | 0 |
| 7.5 | 200 | 100 | 50 |
| 8.5 | 200 | 148 | 74 |
| 10 | 200 | 200 | 100 |
5. Clinical Cut-off
16
Not applicable.
6. Expected value /Reference range
Not applicable.
Conclusion
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device: FIRST RESPONSE™ Gold Digital Pregnancy Test (K123567).