The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.

The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.

Device Description

The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay in determining human chorionic gonadotropin (hCG) concentration in urine. The assay is based on an two-site sandwich immunoassay technology. TD-5301 Pregnancy Test consists of a test strip coated with reagents and enclosed in a plastic cassette. FORA PNC100 Digital Pregnancy Test consists of a meter and a plastic test stick containing a test strip. The meter has a slot where can be plugged with a test stick and activate the procedure. This device uses the same test strip, as TD-5301 Pregnancy Test.

AI/ML Overview

The provided 510(k) summary for the FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent performance study with specific acceptance criteria and a comprehensive study design.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Agreement with Predicate Device	Not explicitly stated, but typically high agreement (e.g., >95%) is expected for substantial equivalence.	Over 99% agreement compared with the predicate device.
Sensitivity	Not explicitly stated.	Tested and verified with both proposed devices. (No specific value provided).
Specificity	Not explicitly stated.	Tested and verified with both proposed devices. (No specific value provided).
Interference	Not explicitly stated.	Tested and verified with both proposed devices.
In-use Stability	Not explicitly stated.	Tested and verified with both proposed devices.
Storage Stability	Not explicitly stated.	Tested and verified with both proposed devices.
Software Validation (FORA PNC100)	Not explicitly stated, but implies meeting functional requirements.	Performed specifically to ensure the performance of FORA PNC100 electronic read-out result.
Meter Reliability (FORA PNC100)	Compliance with safety and EMC standards (IEC/EN 61010-1:2001, IEC/EN 61010-2-101:2002, EN 61326: 2006, IEC 61000-4-2).	Meets the safety and EMC requirements of the specified standards.
User Understandability/Ease of Use	Instructions understandable and clear; devices easy to operate.	Instruction manual understandable and clear enough for user, and devices are easy to operate by following the instructions.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in terms of the number of patient samples or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Performance Studies" section mentions that "sensitivity, specificity and interference, in-use and storage stability studies were tested and verified with both the proposed devices," but details about these studies are not provided.

It also mentions a "user study," but the sample size for this study is not given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The study described focuses on comparison to a predicate device and user-centric evaluation, not on establishing a ground truth by a panel of experts for diagnostic performance metrics.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the submission (substantial equivalence to a predicate pregnancy test), a formal adjudication method for a diagnostic test set is not detailed. The "method comparison" implies a direct comparison of results between the new devices and the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study is not mentioned. The document describes a "method comparison" between the proposed devices and the predicate, and a "user study" for ease of use. It does not mention a study evaluating human readers' improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The FORA PNC100 Digital Pregnancy Test uses an "electronic read-out result" which implies an algorithm interpreting the lateral flow output. The document states "Software validation and meter reliability was performed specifically to ensure the performance of FORA PNC100 electronic read-out result." However, this does not explicitly describe a standalone diagnostic performance study using a clinical test set relative to a defined ground truth, but rather validation of the digital reading mechanism itself. The main performance claim is "over 99% agreement compared with the predicate."

7. The Type of Ground Truth Used

The primary "ground truth" for the performance claims appears to be comparison to the legally marketed predicate device (One Step HCG Urine Pregnancy Test Kit, K071930). The statement "Results show that there is over 99% agreement compared with the predicate" indicates that the predicate's results were used as the reference point for the comparison study. For the user study, the ground truth was presumably user feedback on clarity and ease of operation.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about its size. This type of submission, for a lateral flow assay with a digital reader, typically focuses on analytical performance and comparison to a predicate rather than machine learning model training as one might find in AI/ML device submissions.

9. How the Ground Truth for the Training Set was Established

As no training set is discussed, this information is not applicable/provided.

Summary

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K103487

Page 1-of-3

OCT - 4 2011

Attachment A2

510 (k) Summary

1. Submitter Information Company name TaiDoc Technology Corporation Contact person Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Address Wugu Township, Taipei County, . 24888, Taiwan Phone (+886-2) 2-6625-8188 ext.1176 FAX (+886-2) 2-6625-0288 E-mail teling.hsu@taidoc.com.tw November 22nd, 2010 Date Prepared

Name of Device Trade Names

Common Names Product Code Classification Panel and

Regulations

Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number

FORA PNC100 Digital Pregnancy Test TD-5301 Pregnancy Test Pregnancy Test LCX Human chorionic gonadotropin (hCG) test system Clinical Chemistry Class II 21 CFR 862.1155

One Step HCG Urine Pregnancy Test Kit, Pregnancy Test, Over-the -Counter BLUE CROSS BIO-MEDICAL CO., LTD. K071930

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4. Device Description

TD-5301 Pregnancy Test consists of a test strip coated with reagents and enclosed in a plastic cassette. FORA PNC100 Digital Pregnancy Test consists of a meter and a plastic test stick containing a test strip. The meter has a slot where can be plugged with a test stick and activate the procedure. This device uses the same test strip, as TD-5301 Pregnancy Test.

5. Intended Use

For FORA PNC 100 Digital Pregnancy Test

The device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.

For TD-5301 Pregnancy Test

The device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.

6. Comparison to Predicate Device

A method comparison was performed by two proposed devices and the predicate. Results show that there is over 99% agreement compared with the predicate. The

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visual reading of lines of TD-5301 by lay users yields the same results as the digital readout obtained by FORA PNC100. The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are substantially equivalent to the One Step HCG Urine Pregnancy Test (K071930).

7. Performance Studies

Test strip used with FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is identical. The sensitivity, specificity and interference, in-use and storage stability studies were tested and verified with both the proposed devices.

Software validation and meter reliability was performed specifically to ensure the performance of FORA PNC100 electronic read-out result. The meter of FORA PNC100 Digital Pregnancy Test meets the safety and EMC requirements of IEC/EN 61010-1:2001, IEC/EN 61010-2-101:2002, EN 61326: 2006, IEC 61000-4-2.

A user study was conducted to evaluate two application methods and the easiness of use by following the instructions, and the results demonstrated that the instruction manual of FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is understandable and clear enough for user, and devices are easy to operate by following the instructions.

8. Conclusion

The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test demonstrate satisfactory performance and are suitable for its intended use. The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight on the right side. The bird is composed of three curved lines that suggest movement and feathers. To the left of the bird, there is a circular arrangement of text that appears to be the name of an organization or agency. The text is small and curves along the circle's perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 04 2011

TaiDoc Technology Corporation c/o Teling Hsu Manager, Regulatory Affairs 3F, SF, No. 127, Wugong 2nd Rd. Wugu Township. Taipei County 24888 Taiwan

Re: K103487

Trade Name: Fora PNC100 Digital Pregnancy Test; TD-5301 Pregnancy Test Strip Regulation Number: 21 CFR 862.1345 Regulation Name: Human chorionic gonadotropin test system Regulatory Class: II Product Codes: LCX Dated: September 22, 2011 Received: September 27, 2011

Dear Teling Hsu:

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.

If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (2) CFR Parl 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please nate the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the revoring 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (196-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resources[orYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment A1

Indications for Use

510(k) Number: K103487

Device Name: FORA PNC100 Digital Pregnancy Test

Indications for Use:

This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.

Prescription Use __ (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ruth Checler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) jo3487

Page 1 of 2

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Indications for Use

510(k) Number: K103487

Device Name: TD-5301 Pregnancy Test

Indications for Use:

This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.

Prescription Use __ (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Rute Chaler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety ( 03 510(k) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

Page 2 of _ 2

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.