The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy.

UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home.

It is indicated for use in the early detection of pregnancy.

Device Description

The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test.

Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

AI/ML Overview

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Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Sensitivity	Detect hCG concentrations of 25 mIU/ml or greater.	UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater.
Accuracy (Consumer Use)	100% correlation with professional test in spiked samples.	100% correlation between the UniMark® home user and the UniMark® professional test results in a consumer study.
Specificity	No false positives with related hormones (hLH, hFSH, hTSH).	Negative results obtained with 200 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 uIU/ml hTSH.
Interference	No interference from common substances at specified concentrations.	No interference from Acetaminophen (20 mg/dl), Acetylsalicylic Acid (20 mg/dl), Ascorbic Acid (20 mg/dl), Atropine (20 mg/dl), Caffeine (20 mg/dl), Gentisic Acid (20 mg/dl), Glucose (2000 mg/dl), Hemoglobin (1 mg/dl), Protein (2000 mg/dl), and pH (5 to 9).

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

Non-Clinical (Accuracy): 364 urine specimens (189 positive, 175 negative).
- Provenance: Not explicitly stated, but likely laboratory-based. Retrospective.
Consumer Study: 100 home users, and for each user, 4 spiked urine fractions (0, 20, 30, 1000 mIU/ml hCG) were tested. This means 400 total individual tests performed by home users.
- Provenance: Central New Jersey and New York City, prospective (performed by home users in a test setting).

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

Non-Clinical (Accuracy): The ground truth was established by a "commercially available quantitative visual hCG test." The number and qualifications of experts using this test are not specified, but it's implied to be a standard laboratory method.
Consumer Study: The "organizer or lab assistant" observed and verified user test results. The "lab technician of Biotech Atlantic" subsequently tested the coded controls with the professional (predicate) test. The number and specific qualifications of these individuals are not provided beyond their roles.

4. Adjudication Method for the Test Set

Non-Clinical (Accuracy): No explicit adjudication method is mentioned beyond the comparison to a "commercially available quantitative visual hCG test."
Consumer Study: For the home user tests, the "user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative." For the internal verification, "the lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test." This implies a form of expert verification against a reference method, but not a multi-reader consensus adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described for this device. The consumer study involved multiple users, but it was to assess user interpretation against a control, not to compare human readers with and without AI assistance or to quantify an effect size of AI improvement.

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

Yes, the non-clinical tests (Sensitivity, Accuracy, Specificity, Interference) represent standalone performance of the device without human interpretation (other than the initial reading in a lab setting). The "Accuracy" study compared the UniMark® hCG test (likely read by lab personnel) with another quantitative visual hCG test.

7. The Type of Ground Truth Used

Non-Clinical (Sensitivity, Accuracy, Specificity, Interference): The ground truth was established against known concentrations of hCG (for sensitivity and spiked samples for accuracy) and other hormones/substances (for specificity and interference). For accuracy, a "commercially available quantitative visual hCG test" served as the reference standard.
Consumer Study: The ground truth was established by a lab technician using the professional (predicate) UniMark® hCG Pregnancy Test Device on spiked urine samples (0, 20, 30, and 1000 mIU/ml hCG).

8. The Sample Size for the Training Set

The document does not explicitly describe a training set or a machine learning algorithm for this device. This is a chemical immunoassay, not an AI/ML-based device. Therefore, the concept of a "training set" in the context of AI development is not applicable here.

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

As explained above, there is no mention of a training set as this is not an AI/ML device.

Summary

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510(k) SUMMARY OF INFORMATION RESPECTIN 10. EFFECTIVENESS

A. Name and Address of Submitter

Company Name and Address:	Biotech Atlantic, Inc.6 Industrial Way WestEatontown, NJ 07724
Telephone:	732-389-4789
Fax:	732-389-3837
Contact Person:	Francis Ling Deng
Device Name
Proprietary Name:	UniMark® Home Pregnancy Test Device

Common Name:	hCG Pregnancy Test
Classification:	Human Chorionic Gonadotropin (hCG) Test System

C. Legally Marketed Devices
UniMark® hCG Pregnancy Test (device and strip), K941090

UniMark® Midstream Pregnancy Test Stick, K960174

D. Device description

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negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

E. Intended Use
The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy.
F. Comparison with Predicate Device
A summary comparison of the features of UniMark® Home Pregnancy Test Device, UniMark® hCG Pregnancy Test Device, UniMark® Midstream Pregnancy Test Stick are provided in Table 1 of section 9-A.
G. Performance Data
- (1) Non-Clinical Tests

The tests were done for UniMark® hCG Pregnancy Test (K941090) and summarized in the Performance Characteristics of the UniMark® hCG Pregnancy Test Device. Please see the package insert of UniMark® hCG Pregnancy Test Device (Attachment D, page 20 - 22) and the following summarization.

PERFORMANCE CHARACTERISTICS

Sensitivity

UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater (WHO 3td IS 75/537).

Accuracy

364 randomly selected urine specimen, 189 positive and 175 negative, were analyzed by the UniMark® hCG test in parallel with a commercially available quantitative visual hCG test. The result shows complete agreement.

Specificitv

During the specificity (cross-reactivity) study, the negative results were obtained from all of the UniMark® hCG pregnancy test device assayed with 200 mIU/ml hLH. 1000 mIU/ml hFSH and 1000 uIU/ml hTSH.

Interference Testing

The amount of the following substances added to the urine specimen will not interfere with UniMark® hCG pregnancy test.

Acetaminophen	20	mg/dl
Acetylsalicylic Acid	20	mg/dl

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Ascorbic Acid	20	mg/dl
Atropine	20	mg/dl
Caffeine	20	mg/dl
Gentisic Acid	20	mg/dl
Glucose	2000	mg/dl
Hemoglobin	1	mg/dl
Protein	2000	mg/dl
PH	5 to 9

(2) Consumer Study

The UniMark® Home Pregnancy Test Device was evaluated in a consumer study of 100 home users selected on a random basis as they presented themselves at the offices or labs of the assigned organizers in central New Jersey and New York City. The home users represented a diverse ages, backgrounds, and educational levels.

Urine specimens from non-pregnant women were examined and mixed as an hCG-free specimen. The specimens were split into 4 fractions and spiked with hCG to the concentrations of 0, 20 (20% lower than 25 mIU/ml, the sensitivity level), 30 (20% higher than 25 mIU/ml) and 1000 mIU/ml. Each fraction was further split into dropping bottles. The bottles were labeled with codes. 4 pregnancy devices and one coded control set (0, 20, 30, 1000 mIU/ml) were placed into one bag as one study-kit.

The study was explained to the home users by the organizer or lab technician. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided with one study-kit. The home user performed the test procedure for each of the four controls and read the results. At the conclusion of the test, each home user was asked to complete and sign a questionnaire to obtain feedback on the test. The home user marked the used devices with a control code and her name. The user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative. The form, the control set, and tested devices were put back into the plastic bag as a back-kit. All of the back-kits were sent back to Biotech Atlantic. The lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test (UniMark® hCG Pregnancy Test Device) routinely used in the laboratory.

There was 100% correlation between the UniMark® home user and the UniMark® professional test results, as shown in Table 2 below.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and appear to be connected, forming a single, unified shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

NOV 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Francis Ling Deng Chief Executive Officer Biotech Atlantic, Inc. Bay F. 6 Industrial Way West Eatontown, NJ 07724

Re: K032992

Trade/Device Name: UniMark® Home Pregnancy Test Device Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 23 2003 Received: September 25, 2003

Dear Mr. Deng:

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 III (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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

UniMark® Home Pregnancy Test Device

It is indicated for use in the early detection of pregnancy.

Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use '

Per 21 CRF 801.109

(Optional Format 1-2-96)

Carol C. Benen for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K032992

19 -

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.