QUIK-CHECK HOME PREGNANCY TEST by ACON LABORATORIES, INC.

Quik-Check™ Home Pregnancy is intended for mon-professional/Over-The Counter Quik-Check - Tome Proghancy is more of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Device Description

The Quik-Check™ Home Pregnancy Test Device is intended for non-professional/Over-determination of for the Quik-Checker" Home Pregiancy Tost Dones in thCG) in urine to add in the determination of for the identification of numan Chonomic Golladoneyal (no operioral antibody reagents to selectively pregnancy. The test utilizes a collibination of including unine to the test device and observing for the programments regent with the defect elevated levels of ICC. The assay is conceeded of paillary action along the membrate on formation of comments and forma formation of colored lines. The speciment migrates the specific antibody-hCG-colored conjugate and form a colored conjugate. Postive specificals react with the suggests a negative result.
colored line on the "Test Region" of the membrane. Absence of this suggests anegatives of t colored line on the "rest Region" of the membrant." Hosener of the version will always appear regardless of the presence or absence of hCG.

The Quik-Check™ Home Pregnancy test detects hCG concentrations of 25 mU/ml and geater. The test H has been standardized to the World Health Organization Third International Standard. The addition of M.H.H. has been standardized to the World Italin Organization Introdult to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.

AI/ML Overview

Quik-Check™ Home Pregnancy Test Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Detects hCG concentrations of 25 mU/ml and greater	Detects hCG concentrations of 25 mU/ml and greater (standardized to WHO Third International Standard)
No cross-reactivity with negative and positive urine	No cross-reactivity observed with 0 mIU/ml hCG (negative) and 25 mIU/ml hCG (positive) urine
Suitable for over-the-counter pregnancy testing	Clinical trials confirmed suitability for over-the-counter use, with participants finding the test easy to use, understand, and interpret.

2. Sample Size and Data Provenance for the Test Set

Sample Size: 117 female participants.
Data Provenance: Not explicitly stated, but based on the context of a clinical trial for a home pregnancy test intended for the US market, it is likely that the data was collected in the USA and was prospective in nature.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable as the ground truth for pregnancy status was not established by experts, but rather by the presence or absence of hCG in urine samples, which is a biological marker.

4. Adjudication Method for the Test Set

Not applicable. The determination of hCG levels is a direct measurement, and adjudication by experts for interpreting the results of a home pregnancy test is not typically part of the described method. The study focused on the device's ability to detect hCG and user comprehension.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more relevant for diagnostic imaging or subjective interpretation tasks where human readers' performance with and without AI assistance is being evaluated. This device is a and over-the-counter test designed for self-interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The "clinical trials" described assess the device's ability to detect hCG and for users to correctly interpret the results, operating independently as a diagnostic tool.

7. Type of Ground Truth Used

Biological/Quantitative Measurement: The ground truth for the device's accuracy was the presence or absence of human Chorionic Gonadotropin (hCG) in urine at specific concentrations (0 mIU/ml for negative, 25 mIU/ml for positive). This is a direct biological measurement.
User Comprehension/Interpretation: Additionally, user comprehension of instructions and interpretation of results served as a ground truth component for "suitability for over-the-counter use."

8. Sample Size for the Training Set

The document does not provide information about a separate training set. For in vitro diagnostic devices like home pregnancy tests, "training" often refers to the internal development and calibration processes rather than a distinct clinical training dataset used for machine learning.

9. How Ground Truth for the Training Set Was Established

Not explicitly stated. For such devices, the "training" (development and calibration) would typically involve using known concentrations of hCG in urine samples to ensure the test consistently produces the correct result at and above its stated detection limit (25 mU/ml) and no false positives at 0 mU/ml. This would involve laboratory testing with characterized samples.

Summary

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K012215

AUG - 7 2001

Summary of Safety & Effectiveness

Clinical trials using Quik-Check™ Home Pregnancy Test were conducted which included 117 female Chilical thats using Quile-Chevel - Tremaiority of the participants found Quilt-Check™ Home participants. The results of the study showed and they conferstanding the labeling, reading the instructions, or interpreting the results.

The overall results of the clinical trial confirm that Quik-Check™ Home Pregnancy Test is a suitable test for over-the-counter pregnancy testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2001

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

510(k) Number: K012215 Re: Trade/Device Name: Quik-Check™Home Pregnancy Test Regulation Number: 862.1155 Regulatory Class: II Product Code: I .C.X Dated: July 10, 2001 Received: July 16, 2001

Dear Dr. Tung:

This letter replaces and corrects letter dated August 7, 2001. The device name was incorrect. It was spelled Quick-Check. It should be spelled Quik-Check.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perious on. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Drivinal publisher published to your premarket notification submission does not affect reefice. Frease now, ht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 nredicate 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 Sutman

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

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Indications For Use

510(k) Number:_ ¥012215_______________________________________________________________________________________________________________________________________________________

Device Name: Quik-Check™ Home Pregnancy Test

"Indications For Use" - Quik-Check™ Home Pregnancy is intended for mon-professional/Over-The Counter Quik-Check - Tome Proghancy is more of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Kesia Alexander for Jaan varas
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K012215

Prescription Use
	or (per 21 CFR 801.109)
Over-The-Counter Use

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.