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.

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.

AI/ML Overview

The provided document describes the Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a table format with numerical targets that the device needed to meet directly. Instead, it describes performance studies and their outcomes, implying that successful completion of these studies with satisfactory results constitutes meeting the implicit acceptance criteria for substantial equivalence to a predicate device.

However, based on the performance characteristics mentioned, we can infer some implied criteria and the reported performance:

Implied Acceptance Criteria	Reported Device Performance (Surearly™ Pregnancy Test Strip & Digital Test)
Sensitivity (Limit of Detection)	25 mIU/mL
Specificity (Interference with other hormones)	No interferences with LH, FSH, and TSH
Agreement with Comparative Method (Pregnancy Status)	100% agreement for positive samples (156 samples)
Lay-user Readability and Operability	Instructions easy to understand, device easy to operate, results easy to read (demonstrated by lay-user study)
False positive rate (in non-pregnant women, including menopausal)	0% false positives observed (no false positive result found in 510 non-pregnant women samples)
Accuracy (Overall for lay-users)	No specific overall accuracy percentage provided for lay-users, but implied high accuracy given 100% agreement with comparative method by lab professionals and successful lay-user study.
Electrical Safety (Digital Test only)	Meets all requirements of IEC61010-1:2001, IEC 61010-2-101:2002, IEC 61326-1:2005, and IEC 61326-2-6:2005.
Mechanical Safety (Digital Test only)	Confirmed
Software Validation (Digital Test only)	Performed to ensure performance of electronic read-out result
Environmental Stability	Storage at 2 - 30°C

2. Sample Size and Data Provenance for Test Set

The document describes several studies that can be considered as part of the "test set" evaluation:

Comparison Study (with comparative method by lab professionals):
- Sample Size: Total 456 urine samples.
  - 306 samples from women clinically confirmed pregnant.
  - 150 samples from randomly chosen non-pregnant women.
  - Among the positive samples, 156 were collected from women suspected of being pregnant or in their first trimester.
- Data Provenance: Not explicitly stated, but generally, for such applications, samples are collected from clinical settings relevant to the device's intended use. The document doesn't specify country of origin.
- Retrospective/Prospective: Not explicitly stated. The phrasing "obtained from... women collected from" suggests these were collected for the purpose of the study, so it could be prospective, or existing banked samples fitting the criteria.
Lay-user (OTC) Study:
- Sample Size: Total 198 lay users.
  - 100 non-pregnant women.
  - 98 pregnant women (recruited from those who might be pregnant or had been confirmed pregnant).
- Data Provenance: Not explicitly stated, but implies recruitment of individuals for the study.
- Retrospective/Prospective: Seems prospective, as users "participated" and "tested their own urine by themselves."
Menopausal Study:
- Sample Size: Total 510 samples from non-pregnant women.
  - 170 samples in pre-menopausal age (18-40 years old).
  - 170 samples in peri-menopausal age (41-55 years old).
  - 170 samples in post-menopausal age (over 55 years old).
- Data Provenance: Not explicitly stated.
- Retrospective/Prospective: Not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Comparison Study: Ground truth was established by "lab professionals" using a "comparative method" and "clinically confirmed" pregnancy status. The number and specific qualifications of these lab professionals (e.g., number of years of experience, specific certifications) are not detailed in the provided text.
Lay-user Study: The lay users tested their own urine. "The lay users' same urine samples were also tested by professionals." This implies that expert testing provided a ground truth to compare against the lay users' results. The number and qualifications of these "professionals" are not detailed.
Menopausal Study: The ground truth for their non-pregnant status is implied by categorization into age groups and the intent to assess false positives. "Clinically confirmed" positive samples for the comparison study suggest expert input for ground truth.

4. Adjudication Method for the Test Set

The document does not specify a formal adjudication method (e.g., 2+1, 3+1). For the comparison study, it states results demonstrated "100% agreement with comparative method," which means an adjudicator wasn't needed to resolve discrepancies. For the lay-user study, it mentions that professionals also tested the samples, likely serving as the reference for accuracy, but does not describe the method for resolving discrepancies if any arose between lay user interpretation and professional interpretation.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance to quantify an "effect size" of improvement, was not performed, nor is it applicable to this type of device. These are diagnostic tests where the output (visual lines or digital display) is interpreted by a single user (lay-user). The "Digital" device does involve an automated "reader" (the device itself), but there's no comparison of human reader performance with and without this digital assistance in the traditional MRMC sense.

6. Standalone Performance Study (Algorithm Only)

The Surearly™ Digital Pregnancy Test contains an automated reading component. The document states, "Software validation was performed specifically to ensure the performance of Surearly™ Digital Pregnancy Test electronic read-out result." This confirms that a standalone validation of the algorithm's performance was done to ensure its accuracy in interpreting the test strip results, although the specifics of this validation (e.g., specific metrics, sample size for algorithm testing) are not detailed beyond the mention of the activity.

7. Type of Ground Truth Used

The ground truth primarily used is:

Clinical Confirmation/Comparative Method: For the comparison study, pregnancy status was "clinically confirmed" or determined by "comparative method," which implies a gold standard laboratory assay or clinical assessment for hCG levels.
Known (Non-pregnant) Status: For the menopausal study and the non-pregnant arms of other studies, the non-pregnant status was the ground truth.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is typical for in vitro diagnostic devices like pregnancy tests, which often rely on established biochemical principles and extensive internal R&D/optimization rather than machine learning models that require distinct training sets. The "software validation" for the digital test would be a verification/validation activity rather than a training process.

9. How Ground Truth for Training Set Was Established

As no training set is described, information on how its ground truth was established is not applicable/provided.

Summary

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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.

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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)

K142754

Device Name Surearly™ Pregnancy Test Strip Surearly™ Digital Pregnancy Test

Indications for Use (Describe)

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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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-cha187, Techno 2-ro, Yuseong-guDaejeon, 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
E-mail	jyoung@sugentech.com

2. Name of Device

Trade Name	Surearly™ Pregnancy Test StripSurearly™ 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

5. Intended Use

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6. Indications for Use

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™ PregnancyTest Strip(Candidate Device 1)	Surearly™ DigitalPregnancy Test(Candidate Device 2)	ClearblueEasy DigitalPregnancy Test(Predicate Device)
510(k) number	-	-	K060128
Format	Test Strip	Test Strip,combined with adigital test reader	Test Strip,combined with a digitaltest reader
Indications forUse	Over-the-counter hCGtest intended for thedetection of pregnancy	Over-the-counter hCGtest intended for thedetection of pregnancy	Over-the-counter hCGtest intended for thedetection of pregnancy
Test Principle	Lateral-flowimmunochromatographicassay	Lateral-flowimmunochromatographicassay	Lateral-flowimmunochromatographicassay
Sensitivity	25 mIU/mL	25 mIU/mL	25 mIU/mL
Specificity	No interferenceswith LH, FSH and TSH	No interferenceswith LH, FSH and TSH	No interferenceswith LH, FSH and TSH
Specimen	Urine	Urine	Urine
Sampleapplication	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
Readingmethod	Visual reading	Automatic readingwith a digital display	Automatic readingwith a digital display
Storage	2 - 30°C	2 - 30°C	2 - 30°C
Calibration	WHO 5th InternationalStandard	WHO 5th InternationalStandard	WHO 4th InternationalStandard
Power source	N/A	Battery contained in thedevice	Battery contained in thedevice
Electricalsafetyincluding EMC	N/A	Confirmed	Confirmed
Mechanicalsafety	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.

Regulation Number and Section

§ 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.