UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

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

Device Description

UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. 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 coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG 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 presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive 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

Here's an analysis of the provided text regarding the UniMark® hCG Combo Pregnancy Test, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's performance in terms of sensitivity, accuracy (correlation), and specificity. It also mentions interference testing. However, explicit numerical acceptance criteria (e.g., "sensitivity must be >95%") are not directly stated within the provided text. Instead, the performance is evaluated by comparison to other legally marketed devices.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Sensitivity	"as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens." (K013194, Section H)	"Sensitivity... studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech." (K013194, Section G). The conclusion states: "Further, the sensitivity and accuracy of the UniMark® Combo hCG Pregnancy Test demonstrate that the test is as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens." (K013194, Section H) This implies the device's sensitivity was comparable to the predicate.
Accuracy (Correlation)	"as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens." (K013194, Section H)	"Accuracy (correlation) studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech." (K013194, Section G). The conclusion states: "Further, the sensitivity and accuracy of the UniMark® Combo hCG Pregnancy Test demonstrate that the test is as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens." (K013194, Section H) This implies the device's accuracy was comparable to the predicate.
Specificity	Not explicitly defined as a numerical criterion, but implicitly it should avoid false positives.	Specificity studies were performed. The conclusion highlights an additional reagent (normal mouse IgG) in the sample pad to "block the nonspecific binding sites... This minimizes the potential for false positive readings when serum samples are tested." (K013194, Section F). This suggests efforts to maintain or improve specificity, particularly for serum samples.
Interference Testing	Not explicitly defined, but implies the device should not be unduly affected by common interfering substances.	Interference testing was performed (K013194, Section G). No specific performance results or comparisons are detailed in the provided text.

Note: The application states the UniMark® hCG Combo Pregnancy Test "performs as well as the legally marketed device to which equivalence is claimed, the UniMark® hCG Pregnancy Test when tested with urine specimens." and "as well as a legally marketed combo device when tested with both serum and urine specimens." This establishes the acceptance criteria implicitly as non-inferiority or equivalence to these predicate devices. The specific numerical thresholds for "as well as" are not provided in this summary.

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

Sample Size: The document does not explicitly state the sample size used for the test set in the performance studies.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective.

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

This information is not provided in the given text. As a simple immunoassay device, the "ground truth" (presence or absence of hCG) would typically be established by a different, often more sensitive, laboratory method rather than expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted or described. This type of study typically applies to imaging or diagnostic interpretation tasks where human readers interpret data, often with and without AI assistance. The UniMark® hCG Combo Pregnancy Test is a rapid, qualitative immunoassay designed for direct visual interpretation.

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

This device is a standalone test in the sense that it provides a qualitative result (positive/negative band) without requiring human interpretation of complex data or an accompanying algorithm. The "algorithm" is the biochemical reaction itself that produces the visible band. The performance studies described are inherently of the standalone device, as it's a point-of-care type test.

7. The Type of Ground Truth Used

The ground truth for hCG pregnancy tests typically involves quantitative laboratory assays (e.g., quantitative serum hCG tests) or clinical confirmation of pregnancy (e.g., ultrasound). The document states performance studies were done "in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test." (K013194, Section G). This implies the predicate device served as a reference, or the results were compared against an established "true" state of hCG presence/absence determined by a gold standard (likely a combination of clinical diagnosis and a highly sensitive laboratory method). The document does not explicitly detail the exact method used to establish the "true" hCG status for each sample.

8. The Sample Size for the Training Set

This device is a biochemical immunoassay, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" of data to learn patterns. Therefore, the concept of a "training set" and its size is not applicable to this device. Its performance is based on the chemical formulation and manufacturing precision, which are validated through performance studies.

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

As explained above regarding the training set, this question is not applicable to this type of medical device.

Summary

{0}------------------------------------------------

K013194

510(k) SUMMARY OF INFORMATION RESPECTING SAFETY AND 11. 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 Lee

B. Device Names

Proprietary Name:	UniMark® hCG Combo Pregnancy Test
Common Name:	hCG Pregnancy Test
Classification Name:	Human Chorionic Gonadotropin (hCG) Test System

C. Legally Marketed Device

UniMark® hCG Pregnancy Test, K941090

D. Device Description

{1}------------------------------------------------

E. Intended Use

UniMark® hCG Combo Pregnancy Test (Strip and Device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

F. Comparison with Predicate Device

The UniMark® hCG Combo Pregnancy Test (Strip and Device) is the same as the UniMark® hCG Pregnancy Test (Strip and Device) with the following exceptions:

UniMark® hCG Combo Pregnancy Test is intended for use with both l serum and urine specimens; the UniMark® hCG Pregnancy Test is intended for use with urine specimens only
UniMark® hCG Combo Pregnancy Test contains an additional reagent, ﺳ normal mouse IgG, in the sample pad to block the nonspecific binding sites of the proteins or antibodies in a serum sample. This minimizes the potential for false positive readings when serum samples are tested.

G. Performance Data

The performance characteristics of the UniMark® Combo hCG Pregnancy Test (Strip and Device) are provided in the package insert, and included sensitivity, accuracy (correlation), specificity, and interference testing with both serum and urine specimens. Sensitivity and accuracy studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech.

H. Conclusions Drawn from the Studies

The conclusions drawn from the performance studies demonstrate that the UniMark® Combo hCG Pregnancy Test is as safe, effective, and performs as well as the legally marketed device to which equivalence is claimed, the UniMark® hCG Pregnancy Test when tested with urine specimens. Further, the sensitivity and accuracy of the UniMark® Combo hCG Pregnancy Test demonstrate that the test is as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 0 2001

Mr. Francis Lee Chief Executive Officer Biotech Atlantic, Inc. Meridan Center III Bay F. 6 Industrial Way West Eatontown, NJ 07724

Re: K013194

Trade/Device Name: UniMark ® hCG Combo Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 24, 2001 Received: September 25, 2001

Dear Mr. Lee:

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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

UniMark® hCG Combo Pregnancy Test

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_1

Over-the-Counter-Use

Per 21 CFR 801.109

(Optional Format 1-2-96)

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ 1 0 13 1914

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.