The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. For Laboratory Professional Use Only.

Device Description

The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a lateral flow immunoassay intended for the detection of human Chorionic Gonadotropin (hCG) in urine or serum.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
100% agreement	100% agreement

Note: The acceptance criterion is inherently defined by the reported device performance in this summary – the goal was 100% agreement with the predicate device, and the device achieved it.

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document mentions "A method comparison study" and "100% agreement was observed," but does not specify the number of samples (urine or serum) used in this comparison.
Data Provenance: Not explicitly stated. The document implies an internal study comparing the WH Accu Test™ to a predicate device, but does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not explicitly stated.
Qualifications of experts: The testing was "done by a person who routinely performs pregnancy tests." Specific qualifications (e.g., years of experience, specific role) are not provided beyond this general statement.

4. Adjudication method for the test set:

Not applicable/Not explicitly stated. The study involved a direct comparison to a predicate device rather than human adjudication of a novel test result against an existing gold standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a point-of-care, in-vitro diagnostic device, not an AI-assisted diagnostic tool for imaging or interpretation that would typically involve MRMC studies.

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

This device is inherently a "standalone" test in the sense that the test itself generates the result (color band). The "person who routinely performs pregnancy tests" is likely involved in correctly performing the test and visually interpreting the color bands as per the instructions, rather than providing an independent diagnostic opinion that the device then supports or contradicts. Therefore, no separate "algorithm only" study distinct from the described method comparison was performed or is relevant to this type of device.

7. The type of ground truth used:

The ground truth was established by comparison to a predicate device: the Acon Laboratories hCG One Step Pregnancy Test (Urine/Serum) [510(k) number: K993065]. The predicate device's results were considered the "truth" against which the new device's performance was measured.

8. The sample size for the training set:

Not applicable/Not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning. The term "training set" usually refers to data used to train an algorithm. For this device, performance is based on its chemical and biological reactions, not a trained algorithm.

9. How the ground truth for the training set was established:

Not applicable. As noted above, there is no "training set" for this type of device.

Summary

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AUG 2 2 2005

<051841

510(k) SUMMARY

Date of Summary: August 2, 2005

Product Name:

WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test

Sponsor and Manufacturer

WHPM. Inc. 9440 Telstar Avenue, Unit 1 El Monte, CA 91731

Correspondent

Fran White, President MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

Substantially Equivalent Devices

Manufacturer: Acon Laboratories One Step Pregnancy Test (Urine/Serum) [510(k) number: K993065] Product:

Product Description

The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a lateral flow immunoassay intended for the detection of human Chorionic Gonadotropin (hCG) in urine or serum.

Intended Use

The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. For Laboratory Professional Use Only.

Summary of Technology

The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal solid-phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine and serum. As the urine or serum sample flows through the absorbent portion of the device. the antibodydye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band if hCG concentration is equal to or greater than 25 mIU/mL. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.

Performance Data

A method comparison study was done to compare the performance of the WH Accu

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Test™ Pregnancy Test. These data clearly demonstrate the performance of the product manufactured by WHPM is substantially equivalent to the Acon Laboratories hCG One Step Pregnancy Test (Urine/Serum). 100% agreement was observed.

100% Agreement =

Statement of Safety and Efficacy

The WH Accu Test™ One Step Pregnancy Test when compared with another commonly used pregnancy test (Acon Laboratories hCG One Step Pregnancy Test) demonstrated 100% performance.

These data clearly demonstrate the safety and efficacy of the WH Accu Test™ One Step Pregnancy Test and further confirms the accuracy of the product when compared to a substantially equivalent device currently being sold for professional use. Testing was done by a person who routinely performs pregnancy tests.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2005

WHPM, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates, LLC 163 Cabot Street Beverly, Massachusetts 01915

Re: K051841

Trade/Device Name: WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test Regulation Number: 21 CFR § 862.1155 Regulation Name: Human chorionic gonadotropin test system Regulatory Class: II Product Code: JHI Dated: August 4, 2005 Received: August 5, 2005

Dear Ms. White:

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 premated 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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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): 长ひろくて4人 WH Accu Test One Step Unine/Spream ombo Device Name: Indications For Use:

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

Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Division Sign-Off

Evaluation

Office of Vitro Diagnostic Device

510(k) K051341

and Safety

Page 1 of 1

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.