The AZOG hCG One-Step (Urine) Pregnancy Home Test (DipStick, Cassette and Midstream) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy at home.

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Midstream) are intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. The Test is for the early detection of pregnancy.

Device Description

The AZOG hCG One-Step Urine Pregnancy Home Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AZOG, Inc. hCG One-Step Urine Pregnancy Home Test:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Agreement with a similar device (presumably a legally marketed predicate device)	≥ 99%
Sensitivity (detection limit for hCG)	Detects hCG at 25 mIU/mL or greater.
Specificity concerning cross-reactivity with LH (1000 mIU/mL), FSH (1000 mIU/mL), and TSH (1000 µIU/mL)	No cross-reactivity observed with LH, FSH, and TSH at the specified concentrations in negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens.
Interference (absence of interference from potentially interfering substances)	None of the potentially interfering substances tested interfered in the assay.
Assay Precision/Tolerance (within-run, between-runs, between operators)	No differences observed within run (5 replicates), between runs (three different assay days), or between operators (two operators).

Study Details

This document primarily describes correlative and analytical studies, not a clinical effectiveness study.

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

Correlation Study: 310 urine specimens.
Assay Precision/Tolerance, Sensitivity, Specificity, Interference Studies: The document refers to "a panel of 3 coded specimens" for precision testing (negative, low positive, high positive) and does not specify a separate sample size for the sensitivity, specificity, and interference studies, but implies these were conducted in a laboratory setting using controlled samples.
Data Provenance: Not specified, but the context of an FDA 510(k) submission suggests in-house laboratory testing rather than data from diverse countries or retrospective patient cohorts from clinics. These are likely prospective, controlled laboratory studies.

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

Correlation Study: The "ground truth" for the correlation study was established by results obtained from a "similar device" (a legally marketed predicate device). No experts are explicitly mentioned for ground truth establishment for this comparison.
Analytical Studies (Sensitivity, Specificity, Interference): The "ground truth" for these analytical studies was based on the known concentrations of hCG, LH, FSH, TSH, and interfering substances in the prepared samples. This does not involve human expert interpretation of results.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as these studies primarily involve direct comparison to reference methods or known concentrations, rather than human interpretation requiring consensus.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The studies focused on the analytical performance of the device and its correlation with a similar existing device. There is no information about human readers or their improvement with or without AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, the studies described are essentially standalone performance studies for the device (an immunoassay, not an algorithm in the AI sense). The device's performance, such as its ability to detect hCG at a certain level, its specificity, and its agreement with another device, is evaluated without human interpretation influencing the device's direct output. The test itself provides a visual result (colored lines) that a user then interprets.

7. The Type of Ground Truth Used

Correlation Study: The "ground truth" was the results obtained from a similar legally marketed predicate device.
Sensitivity, Specificity, and Interference Studies: The "ground truth" was based on known, controlled concentrations of the target analyte (hCG) and other substances (LH, FSH, TSH, interfering substances) in the prepared urine specimens. These are laboratory-derived ground truths.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is common for traditional immunoassay device submissions, as the "training" (development and optimization) of such devices often involves iterative lab testing and formulation adjustments rather than a distinct, quantifiable "training set" like in machine learning. The studies described are for validation of the finalized device.

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

As a training set is not explicitly mentioned in the context of this traditional immunoassay device, the method for establishing its ground truth is also not detailed. The development process would have involved establishing the analytical accuracy of different formulations and reagent concentrations against known hCG standards to optimize the device's performance characteristics.

Summary

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K041748

AUG - 9 2004

510(k) SUMMARY

DEVICE NAME: AZOG,Inc. One-Step Urine Pregnancy Home Test (DipStick, Cassette and Midstream).

APPLICANT NAME:	AZOG, Inc.1011 US HWY 22 WESTPHILLIPSBURG, NJ 08865
CONTACT:	AZUBUIKE OGALATel.: (908) 213-2900Fax: (908) 213-2901

INTENDED USE:

DESCRIPTION OF THE DEVICE

111

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream]

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SAFETY AND EFFECTIVENESS DATA:

Assay Precision/Tolerance (K022680 and K022681)

An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) was conducted using a panel of 3 coded specimens. The proficiency panel contained negative, low positive and high positive specimens. Two different operators tested each level in replicates of five over a period of three days.

No differences were observed within run (5 replicates), between runs (three different assay days), or between operators (two operators).

Correlation (K022680. K022681 and current submission)

A total of 310 urine specimens were tested using the AZOG, Inc. hCG One-StepUrine Pregnancy Test (DipStick, Cassette and Midstream). When these results were compared to results obtained from a similar device, the result demonstrated overall agreement of greater than or equal to 99% of the AZOG, Inc. hCG One-Step Urine Pregnancy Home Test (DipStick, Cassette and Midstream).

Sensitivity and Specificity (K022680 and K022681)

The AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) detects hCG at 25 mIU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (1000 mIU/mL), FSH (1000 mIU/mL) and TSH (1000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no crossreactivity.

Interference Study (K022680 and K022681)

None of the potentially interfering substances tested interfered in the AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) assay.

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream]

112

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like figure in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text, which appears to be part of the logo's branding. The overall design is simple and symbolic, likely representing an organization or company related to health or public service.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2004

Mr. Azubuike Ogala President/V.P., Research & Development Azog, Inc. 1011 US Hwy 22 West Phillipsburg, NJ 08865

K041748 Re:

K0+17+6
Trade/Device Name: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (Dipstick, Cassette and Midstream)

Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 18, 2004 Received: June 29, 2004

Dear Mr.Ogala:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated)76, the enactment date of the Medical Device Amendments, or to conninered provide in accordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that Lo novice, subject to the general controls provisions of the Act. The r ou may, mercrore, mains of the Act include requirements for annual registration, listing of general controls profitering 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 n may of bund 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 or any I sactar band 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) This letter will anow you'to ought heating of substantial equivalence of your device to a legally premarket notification: "The PDF intembers on the sour 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, If you destic specific mixed advertising of your device, please contact the Office of or questions on the promise Evaluation and Safety at (301) 594-3084. Also, please note the In I the Diagnostic Do reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou inay ovain other general see 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,

Jean M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. 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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Indications for Use

510(k) Number (if known): K041748

Device Name: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (Dipstick, Cassette and Midstream)

Indications For Use: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Indications FOF OSE. AZOG, file: not one enp this if Human Chrisnic Gonadotropin (hCG) in
Midstream) are intended for the qualitative determinel Une The for the for the early Midstream) are intended for the Qualiative determination of Human United The Test is for the early detection of pregnancy.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

11.201 Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K0411748

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.