The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.

Device Description

The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by applying urine sample through urination, or dipping test device into collected urine sample, and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane. A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". The ACON Quik-Check II Midstream Home Pregnancy Test qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no crossreactivity.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ACON Quik-Check II Midstream Home Pregnancy Test

The provided documentation describes the ACON Quik-Check II Midstream Home Pregnancy Test, a qualitative test designed for over-the-counter use to detect elevated levels of human Chorionic Gonadotropin (hCG) in urine. The primary study presented aims to establish substantial equivalence to a predicate device, the ACON Midstream Home Pregnancy Test (K983090).

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages or thresholds for sensitivity, specificity, or accuracy. Instead, the reported performance focuses on comparative accuracy to a predicate device. The general implicit acceptance criterion for a device intended for over-the-counter use is high accuracy and ease of use for the target consumer.

Acceptance Criterion (Implicit)	Reported Device Performance
High correlation/accuracy with predicate device	Over 99% correlation between ACON Quik-Check II Midstream Home Pregnancy Test and the current ACON Midstream Pregnancy Test (K983090) in two studies (consumer field study and retrospective focus group study).
Qualitative detection of hCG at 25 mIU/ml cutoff	The device "qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml." This is a design specification rather than an acceptance criterion from a study, but it is a key functional requirement.
Absence of cross-reactivity with related hormones	"The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity." This demonstrates specificity.
User comprehension and ease of use	"The results also showed that the vast majority of the participants found ACON Quik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results." This is an important criterion for an OTC device.
Robustness under various conditions (specificity, interference, etc.)	Additional laboratory study results on performance include specificity, interference substances, urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions. (Specific data not provided in this summary).

2. Sample Sizes and Data Provenance

Test Sets:
- Consumer Field Study: 113 female participants.
- Retrospective Focus Group Study: 35 female participants.
Data Provenance: The document does not explicitly state the country of origin for the data. The studies are described as "clinical studies" and "laboratory studies," implying they were conducted in a controlled environment, likely in the US where the device is intended for market. The "consumer field study" and "retrospective focus group study" suggest real-world or simulated real-world usage by consumers. Both studies are described as retrospective in terms of comparing results to an existing device.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. Given the nature of a home pregnancy test comparing to a predicate, the "ground truth" for the test sets would likely be the results from the predicate device itself, which is implicitly considered accurate for the purpose of demonstrating equivalence.

4. Adjudication Method

The document does not specify an adjudication method (such as 2+1 or 3+1). Since the studies focus on correlation between two devices, it's implied that the results from the predicate device serve as the primary comparison point. There is no mention of independent interpretation or resolution of discrepancies.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is a standalone diagnostic test, not an AI-assisted diagnostic tool for interpretation by humans.

6. Standalone Performance Study

A standalone performance study was implicitly done in the context of comparing the new device against the predicate device. The device's performance is reported in terms of its correlation with the predicate. The "additional laboratory study results" on specificity, interference, pH, specific gravity, and hook effect also represent standalone evaluations of the device's inherent characteristics.

7. Type of Ground Truth Used

The ground truth used for the reported clinical studies was primarily the results obtained from the predicate device, the ACON Midstream Home Pregnancy Test (K983090). This indicates that the assessment of the new device's accuracy relied on its agreement with an already legally marketed and presumed accurate test.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is typical for simple diagnostic assays like pregnancy tests, which are usually developed based on known biochemical principles and then validated through clinical and analytical studies, rather than "trained" in the machine learning sense.

9. How Ground Truth for the Training Set Was Established

As there is no specific mention of a training set in the context of a machine learning algorithm, there is no information on how its ground truth was established. The development of the device likely relied on established scientific understanding of hCG detection rather than a data-driven training process. The performance characteristics like the 25 mIU/ml cutoff and cross-reactivity were likely determined through laboratory experimentation and standardization against international reference materials (e.g., World Health Organization Third International Standard).

Summary

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III. 510(k) Summary

This summary of 510(k) safety and effective ness information is being submitted in accordance with the regulation of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K032510.

Device Names:

ACON Quik-Check II Midstream Home Pregnancy Test

Common Name:

Pregnancy Test Kit, Over-the-Counter

Classification Name:

Gonadotropin

Name of the Predicate Device

ACON Midstream Home Pregnancy Test (K983090)

Medical Specialty:

Clinical Chemistry

Device Description:

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A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid".

The ACON Quik-Check II Midstream Home Pregnancy Test qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no crossreactivity.

Intended Use:

Clinical Studies:

Clinical studies were conducted to compare the results of ACON Quik-Check II Midstream home Pregnancy Test to the current ACON Midstream Pregnancy Test (K983090). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The results also showed that the vast majority of the participants found ACON Ouik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

Additional Study to Establish Substantial Equivalence:

Additional laboratory study results on performance include specificity, interference substances, urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions.

The overall performance data indicate that ACON Quik-Check II Midstream Home Pregnancy Test (Home Tests) is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K983090) currently on the U. S. OTC market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white circular logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle. Inside the circle is a symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

SEP 2 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121

Re: K032510

Trade/Device Name: ACON Quik-Check II Mainstream Home Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 5, 2003 Received: September 11, 2003

Dear Dr. Tung:

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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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 Sutman

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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Indications For Use V.

510(k) Number: K032510

Device Name: ACON Quik-Check II Midstream Home Pregnancy Test

The ACON Quik-Check II Midstream Home Pregnancy Test is a "Indications for Use": qualitative test for the detection of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

KO32510 510(k).

(Please do not write below this point)

Concurrence of CDRH, Office of the In vitro Diagnostic Device Evaluation and Safety

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(per 21 CFR 801.109)

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.