The QuickVue® One-Step hCG-Urine is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The QuickVue One-Step hCG-Urine is intended for use by health care professionals.

Device Description

The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy. The test, a lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pink-to-purple Test Line will also appear. The result is read at three minutes. If no blue procedural Control Line develops, the result is considered invalid.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QuickVue® One-Step hCG-Urine device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Requirement	Reported Device Performance
Accuracy	> 99% accuracy when compared to other FDA-cleared devices for qualitative hCG detection.	An accuracy exceeding 99% was observed.
Precision	Excellent intra- and inter-assay precision.	The test was shown to have excellent intra- and inter-assay precision.
Lot-to-Lot Consistency	Reproducibly manufacturable.	Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
Interference	No interference from common drugs, chemicals, and biologicals.	Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
Usability (Physician's Office Laboratory)	Doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.	Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.
Substantial Equivalence	Similar to other commercially distributed in vitro tests in terms of features and intended use.	The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use.

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

Sample Size: Not explicitly stated for the primary accuracy study comparing the QuickVue® device to other FDA-cleared devices. It mentions "Using urine samples obtained from women presenting for pregnancy testing."
Data Provenance:
- Accuracy Study: Urine samples from women presenting for pregnancy testing (implicitly prospective data collection, but not explicitly stated as such, suggesting real-world clinical samples).
- Physician's Office Laboratory Studies: Conducted at "three geographically distinct sites in the United States." This implies retrospective use of existing samples or prospective collection within those sites, but the exact collection method isn't detailed.

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

This information is not provided in the given text. For a qualitative hCG test, the "ground truth" would typically come from a reference method or a panel of experts confirming pregnancy status, but the details are absent.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 MRMC study was done. This device is an in-vitro diagnostic (IVD) rapid immunoassay for qualitative detection of hCG in urine, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study. The "readers" would be the healthcare professionals performing and interpreting the test based on the color change. The Physician's Office Laboratory studies assessed the reproducibility and accuracy of personnel.

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

Yes, a standalone study was done in the sense that the device itself, as an immunoassay, produces a result (color change) that is then interpreted. The "accuracy exceeding 99%" was reported for the device's performance against FDA-cleared predicate devices. The Physician's Office Laboratory studies evaluate human interpretation of the device's standalone output.

7. The Type of Ground Truth Used

The ground truth for the accuracy study comparing the QuickVue® device was based on results from "other FDA-cleared devices for qualitative hCG detection." This implies a comparison to established, legally marketed diagnostic tests that themselves have a defined accuracy against the biological presence of hCG.
For the Physician's Office Laboratory studies, the ground truth was referred to as "expected results." This likely refers to a pre-determined or confirmed pregnancy status of the urine samples used.

8. The Sample Size for the Training Set

This information is not provided in the given text. As the device is an immunoassay (not an AI/ML algorithm), the concept of a "training set" in the context of machine learning does not directly apply. The development would involve analytical verification and validation using various concentrations of hCG and negative controls.

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

This information is not provided and is not applicable in the typical AI/ML sense. For immunoassay development, ground truth for validation samples (analogous to a "training set" in a very loose sense for analytical performance) would be established by preparing samples with known concentrations of hCG and negative controls, and potentially using a highly sensitive and specific reference method.

Summary

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0(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K 472742

Product: uickVue® One-Step hCG-Urine

AUG 2 9 1997

Manufacturer: OUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.

ce Classification:

evice, OuickVue One-Step hCG-Urine, is similar to other FDA-cleared s used for the qualitative detection of human chorionic gonadotropin in urine. The test is used in the early detection of pregnancy and is d to measure hCG, a placental hormone, in urine (21 CFR 862.1155). DA has proposed that hCG test systems be classified as Class II.

ended Use:

e test is a rapid immunoassay for the qualitative detection of hCG in urine. his test is to be used for the early detection of pregnancy.

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 corcentration 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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ciple of the Test:

est, a lateral-flow immunoassay, employs monoclonal and polyclonal bodies. Shortly after addition of the urine sample, a blue procedural ol Line will appear. If hCG is present in the sample, a pink-to-purple Line will also appear. The result is read at three minutes. If no blue cedural Control Line develops, the result is considered invalid.

Safety and Effectiveness:

Jumerous studies were undertaken to document the performance haracteristics and the substantial equivalence of the test to other ommercially available products for the qualitative detection of hCG in urine. hese studies included the following:

· The test was shown to be similar to other commercially distributed in vitro 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.
· Using urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to other FDA-cleared devices for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
· Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.

Conclusion:

These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for use by health care professionals. 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 eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Aarrinistration 2098 Gaither Road Rockville MD 20850

AUG 2 9 1097

Robin Weiner Vice President, Clinical Develop. & Reg. Affairs QUIDEL Corporation 10165 Mc Kellar Court San Diego, California 92121

K972742 Re: QuickVue® One-Step hCG-Urine Requlatory Class: II Product Code: JHI July 22, 1997 Dated: Received: July 23, 1997

Dear Ms. Weiner:

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, Druq, 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. A 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 requlation (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 Reqister. 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 requlations.

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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 note the 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 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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510(k) Number (if known):	K972742
Device Name:	QuickVue® One-Step hCG-Urine

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K972742

Prescription Use (Per 21 CFR 801.109)	OR	Over-The Counter Use
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(Optional Format 1-2-96)

ಷ

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.