The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe-counter home use.
The Quidel Home Pregnancy Test is intended for the qualitative detection of hCG in urine for the early detection of pregnancy. The test is for over-the-counter home use.

Device Description

The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink Test Line along with a blue Control Line is visible in the large Result Window to indicate a positive result. If hCG is not present in the sample, only the blue Control Line is visible in the large Result Window to indicate a negative result.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quidel Home Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it outlines the areas where the device's performance was evaluated and deemed acceptable. The reported device performance is described generally as "excellent" or "similar to other commercially available products."

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: Similar features and intended use to existing marketed tests.	The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
Precision: Intra- and inter-assay consistency.	The test was shown to have excellent intra- and inter-assay precision.
Lot-to-Lot Consistency: Reproducible manufacturing.	Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
Interference: Not affected by common drugs, chemicals, and biologicals.	Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
Consumer Usability: Lay users can correctly perform and interpret the test.	A consumer study was conducted in order to show that lay users could read the package insert, perform the test, and obtain results similar to results obtained by clinic personnel.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for any of the test sets (precision, lot-to-lot consistency, interference, or consumer study).
- Data Provenance: Not explicitly stated, though a consumer study would imply a prospective, real-world setting. The other studies (precision, lot-to-lot, interference) are typically conducted in a laboratory setting. There is no mention of country of origin for the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the consumer study, the "ground truth" was established by clinic personnel whose results were compared to those of lay users. The number of clinic personnel and their specific qualifications (e.g., nurses, lab technicians) are not specified.
- For the other performance studies (precision, consistency, interference), the ground truth would be based on established analytical methods and reference standards for hCG detection, likely performed by trained laboratory professionals, but the document does not specify the number or qualifications of these experts.
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For the consumer study, it implies direct comparison between lay user results and clinic personnel results rather than an adjudication process between conflicting interpretations.
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, an MRMC comparative effectiveness study was not done. This device is a rapid immunoassay for home use, not an AI-assisted diagnostic device, so this type of study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the intrinsic performance characteristics such as precision, lot-to-lot consistency, and interference studies represent the standalone performance of the assay itself, demonstrating its ability to detect hCG in urine samples. The device is a "standalone" test kit that provides a visible result without external analytical equipment or further human interpretation beyond reading the lines.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Ground Truth for Performance Studies: For precision, lot-to-lot, and interference studies, the ground truth would be based on known concentrations of hCG in prepared samples or reference materials, confirmed by established laboratory methods.
- Clinical/User Ground Truth for Consumer Study: For the consumer study, the ground truth for correct test interpretation was established by the results obtained by clinic personnel. The ultimate "ground truth" for pregnancy itself is physiological (presence of hCG), but the study focused on whether users could correctly identify the presence/absence of hCG based on the test lines.
The sample size for the training set:
- The document does not mention a training set. This is because the device is a chemical immunoassay, not a machine learning or AI-based system that requires training data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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JUN 3 1998

K981722

SUMMARY OF SAFETY AND EFFECTIVENESS XI.

Product OUIDEL Home Pregnancy Test

Manufacturer

QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.

Device Classification

The device, Quidel Home Pregnancy Test, is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG). The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.

Intended Use

The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe-counter home use.

Physiologic Basis for the Assay

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.

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Principle of the Test

Safety and Effectiveness

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG. These studies included the following:

The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
· The test was shown to have excellent intra- and inter-assay precision.
· Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
· Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
A consumer study was conducted in order to show that lay users could read the package insert, perform the test and obtain results similar to results obtained by clinic personnel.

Conclusion

These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for over-the-counter home use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 1698 JUN

McMullen E. Joseph Manager, Regulatory Compliance Quidel Corporation 10165 McKellar Court San Diego, California 92121

Re : K981722 Quidel Home Pregnancy Test Regulatory Class: II Product Code: LCX Dated: May 14, 1998 Received: May 15, 1998

Dear Mr. McMullen:

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 (for the indications for use stated in the enclosure) 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 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 notethe regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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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1_ Page _________________________________________________________________________________________________________________________________________________________________________

re 98 510(k) Number (if known):

Device Name:

Quidel Home Pregnancy Test

Indications for Use:

The Quidel Home Pregnancy Test is intended for the qualitative detection of hCG in urine for the early detection of pregnancy. The test is for over-the-counter home use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The Counter Use OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Simi-C in Division . Il succe 510(k) Number

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.