(560 days)
Not Found
No
The device description and performance studies focus on a lateral-flow immunochromatographic assay and a digital reader that detects colored lines. There is no mention of AI or ML in the text.
No
The device is an in vitro diagnostic medical device used for the qualitative detection of hCG to aid in the early determination of pregnancy. It does not treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "in vitro diagnostic medical device[s] for the rapid detection of human chorionic gonadotropin (hCG) in urine." The purpose is to "aid in the early determination of pregnancy," which is a diagnostic function.
No
The device description clearly details physical components like test strips, a digital reader with an LCD display, an absorbent tip, and plastic housing, indicating it is a hardware device with some software functionality for the digital version.
Yes, both devices are explicitly stated to be IVDs (In Vitro Diagnostics).
The document repeatedly uses the phrase "in vitro diagnostic medical device" when describing both the Surearly™ Pregnancy Test Strip and the Surearly™ Digital Pregnancy Test.
Furthermore, the intended use clearly describes the devices as being for the "rapid detection of human chorionic gonadotropin (hCG) in urine," which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Product codes
LCX
Device Description
Both Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay for the detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early determination of pregnancy. The assays are based on a lateral-flow immunochromatographic assay.
Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.
Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
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 (OTC) use only.
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
Comparison Study:
Sample Size: 456 urine samples (306 from clinically confirmed pregnant women, 150 from non-pregnant women). Among positive samples, 156 were from women suspected of being pregnant or in their first trimester.
Data Source: Urine samples from women aged 18 to 48 years old.
Annotation Protocol: Not explicitly stated, but results were compared against a "comparative method" by lab professionals.
Lay-user (OTC) Study:
Sample Size: 198 lay users (100 non-pregnant women, 98 pregnant women) aged 18 to 45 years.
Data Source: Users' own urine.
Annotation Protocol: Lay users tested their own urine according to instructions for use in English. Their same urine samples were also tested by professionals. Users were asked questions about ease of use, understanding instructions, and ease of reading results.
Menopausal Study:
Sample Size: 510 samples from non-pregnant women (170 samples in pre-menopausal age of 18-40 years old, 170 samples in peri-menopausal age of 41-55 years old, and 170 samples in post-menopausal age over 55 years old).
Data Source: Not explicitly stated, but implies urine samples from non-pregnant women across different age groups.
Annotation Protocol: Not explicitly stated, but aims to demonstrate the absence of false positives from non-pregnant women.
Summary of Performance Studies
Comparison Study:
Study Type: Comparison study
Sample Size: 456 urine samples
Key Results: The results of the candidate devices demonstrated 100% agreement with comparative method.
Lay-user (OTC) Study:
Study Type: Lay-user (OTC) study
Sample Size: 198 lay users
Key Results: The instructions for use of Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test were understandable and clear enough for lay users, and devices were easy to operate by following the instructions.
Menopausal Study:
Study Type: Menopausal study
Sample Size: 510 samples
Key Results: No false positive result was found and all test results were negative.
Key Metrics
Sensitivity: 25 mIU/mL
Specificity: No interferences with LH, FSH and TSH
Comparison study: 100% agreement with comparative method for positive samples.
Menopausal study: 0% false positive rate.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure composed of three profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and dimension. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
SUGENTECH, INC. JIYOUNG KWAK INTERNATIONAL SALES MANAGER SHINYOUNG PALACE TOWER, 21 HWANGSAEUL-RO 360BEON-GIL, BUNDANG-GU,SEONGNAM 463-824, KOREA
Re: K142754 Trade/Device Name: Surearly™ Pregnancy Test Strip. Surearly™ Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: March 30, 2016 Received: April 4, 2016
Dear Jiyoung Kwak:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Surearly™ Pregnancy Test Strip Surearly™ Digital Pregnancy Test
Indications for Use (Describe)
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
ال Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Date of Summary Preparation: March 30, 2016 Reference 510(k) number in process: K142754
1. Submitter Information
| Company Name | Sugentech, Inc. |
|---|---|
| Address | Room 214,215, Migun Techno World 2-cha |
| 187, Techno 2-ro, Yuseong-gu | |
| Daejeon, 305-811, Republic of Korea | |
| Phone | ++82-42-364-5001 |
| Fax | ++82-42-367-3030 |
2. Contact Information
| Contact Person | Jiyoung Kwak(Ms.), International Business Manager |
|---|---|
| Company Name | Sugentech, Inc. |
| Address (Sales office) | Shinyoung Palace Tower, |
| 21 Hwangsaeul-ro 360beon-gil, Bundang-gu, | |
| Seongnam-si, Gyeonggi-do, 463-824, | |
| Republic of Korea | |
| Phone | ++82-31-701-5117 |
| Fax | ++82-42-367-3030 |
| jyoung@sugentech.com |
2. Name of Device
| Trade Name | Surearly™ Pregnancy Test Strip
Surearly™ Digital Pregnancy Test |
|----------------------|--------------------------------------------------------------------|
| Common Name | Pregnancy Test |
| Product Code | LCX / Kit, Test, Pregnancy, Hcg, Over The Counter |
| Regulation Section | 21 CFR §862.1155 |
| Classification Panel | Clinical Chemistry (75) |
| Device Class | Class II |
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3. Predicate Device
| Trade Name | Clearblue Easy Digital Pregnancy Test |
|---|---|
| 510(k) Number | K060128 |
| Submitter | Unipath Ltd. |
4. Device Description
Both Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay for the detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early determination of pregnancy. The assays are based on a lateral-flow immunochromatographic assay.
Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.
Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
5. Intended Use
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for overthe-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for overthe-counter (OTC) use only.
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6. Indications for Use
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for overthe-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for overthe-counter (OTC) use only.
7. Comparison to Predicate Device
A summary comparison of the features of the candidate devices (Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test) and the predicate device is provided in Table 5-1 as follows:
| Table 5.1 - Comparison table between the candidate devices and the predicate device | ||
|---|---|---|
| Item | Surearly™ Pregnancy
Test Strip
(Candidate Device 1) | Surearly™ Digital
Pregnancy Test
(Candidate Device 2) | Clearblue
Easy Digital
Pregnancy Test
(Predicate Device) |
|------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 510(k) number | - | - | K060128 |
| Format | Test Strip | Test Strip,
combined with a
digital test reader | Test Strip,
combined with a digital
test reader |
| Indications for
Use | Over-the-counter hCG
test intended for the
detection of pregnancy | Over-the-counter hCG
test intended for the
detection of pregnancy | Over-the-counter hCG
test intended for the
detection of pregnancy |
| Test Principle | Lateral-flow
immunochromatographic
assay | Lateral-flow
immunochromatographic
assay | Lateral-flow
immunochromatographic
assay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL | 25 mIU/mL |
| Specificity | No interferences
with LH, FSH and TSH | No interferences
with LH, FSH and TSH | No interferences
with LH, FSH and TSH |
| Specimen | Urine | Urine | Urine |
| Sample
application | Dip | Dip and Stream | Dip and Stream |
| Sampling time | Dip (5 seconds) | Dip (10 seconds)
Stream (5 seconds) | Dip (20 seconds)
Stream (5 seconds) |
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Image /page/6/Picture/0 description: The image shows the logo for Sugentech, which includes a stylized purple "S" shape. Below the logo is the text "510(k) Notification / 5. 510(k) Summary". The text is in a smaller font size than the logo.
| Read time | In 5 minutes | Within 3 minutes | Within 3 minutes |
|---|---|---|---|
| Reading | |||
| method | Visual reading | Automatic reading | |
| with a digital display | Automatic reading | ||
| with a digital display | |||
| Storage | 2 - 30°C | 2 - 30°C | 2 - 30°C |
| Calibration | WHO 5th International | ||
| Standard | WHO 5th International | ||
| Standard | WHO 4th International | ||
| Standard | |||
| Power source | N/A | Battery contained in the | |
| device | Battery contained in the | ||
| device | |||
| Electrical | |||
| safety | |||
| including EMC | N/A | Confirmed | Confirmed |
| Mechanical | |||
| safety | N/A | Confirmed | Confirmed |
8. Comparison / Lay-user Studies including menopausal study
8.1 Comparison Study
Comparison studies between the candidate devices (Surearly™ Pregnancy Test Strip
and Surearly™ Digital Pregnancy Test) and comparative method were conducted by lab
professionals using total 456 urine samples obtained from 18 to 48 years old women collected from 306 women who were clinically confirmed to be pregnant and another 150 women who were randomly chosen from non-pregnant women.
Among the positive samples, 156 were collected from women who were suspected of being pregnant or pregnant women in their first trimester. The results of the candidate devices demonstrated 100% agreement with comparative method.
8.2 Lay-user (OTC) Study
Total 198 lay users aged 18 to 45 years participated in the lay user study. 100 were nonpregnant women and 98 were pregnant women. The pregnant women were recruited from who might be pregnant or have been confirmed to be pregnant.
For the digital test, both urine midstream and dip procedures were tested as claimed to demonstrate the equivalency of both testing procedures. 100 users tested the digital device using the stream procedure and another 98 users tested it using the dip procedure.
All lay users tested their own urine by themselves with Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test according to the instructions for use in English. The lay users' same urine samples were also tested by professionals.
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After the test, lay users were also asked the questions, e.g. whether the test was easy to run, the instructions for use was easy to understand and the test results were easy to read. The results demonstrated that the instructions for use of Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test were understandable and clear enough for lay users, and devices were easy to operate by following the instructions.
8.3 Menopausal Study
Menopausal study was performed with total 510 samples from non-pregnant women to demonstrate to what degree the test devices might have false positive results from women who are not pregnant. (170 samples in pre-menopausal age of 18-40 years old, 170 samples in peri-menopausal age of 41-55 years old, and 170 samples in postmenopausal age over 55 years old).
No false positive result was found and all test results were negative.
9. Other Information about Performance Characteristics and Safety
Further laboratory studies have been carried out for sensitivity/cut-off (including lay user cut-off study), specificity, interference (including pH effect, ethanol and specific gravity ranges), high dose hook effect, precision/reproducibility, and stability to verify the performances of Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test.
These results have demonstrated that Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test perform satisfactorily when used according to the instructions for use.
As the product, Surearly™ Digital Pregnancy Test includes software and electrical components, additional verification and validation activities were also performed. Software validation was performed specifically to ensure the performance of Surearly™ Digital Pregnancy Test electronic read-out result.
The electrical safety including EMC for the test reader was evaluated according to the IEC standards, IEC61010-1:2001 (Second edition), IEC 61010-2-101: 2002 (First edition) IEC 61326-1: 2005, and IEC 61326-2-6:2005. The test reader meets all the requirements of the standards.
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10. Conclusions
The overall performance data in this submission supports that Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test are safe, effective and substantially equivalent to the predicate, Clearblue Easy Digital Pregnancy test (K060128) which currently marketed in the United States.