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 test is intended for use by health care professionals.

Device Description

The test is a rapid immunoassay for the qualitative detection of hCG in urine. Urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.

AI/ML Overview

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

Acceptance Criteria and Device Performance

The document doesn't explicitly list numerical acceptance criteria in a table format, but it describes the types of studies performed and the qualitative outcomes. The primary implicit acceptance criterion is "substantial equivalence" to legally marketed predicate devices, supported by demonstrating similar performance characteristics.

Acceptance Criteria Category	Reported Device Performance
Similar features and intended use	Demonstrated similarity to other commercially distributed in vitro tests.
Intra- and inter-assay precision	Shown to have "excellent" intra- and inter-assay precision.
Lot-to-lot consistency	Analyses showed the test to be "reproducibly manufacturable."
Interference testing	Common drugs, chemicals, and biologicals were shown "not to interfere" with the test's performance.
Accuracy (compared to predicate)	An accuracy "exceeding 99%" was observed in a multi-center field clinical trial comparing it to a commercially available qualitative hCG test.
Usability by healthcare professionals	Physicians' Office studies demonstrated that personnel with diverse educational backgrounds could perform the test "accurately and reproducibly."

Study Details

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

Test Set Sample Size: Not explicitly stated as a number of individual samples. The text mentions "Using samples obtained from women presenting for pregnancy testing" for the accuracy study.
Data Provenance:
- Country of origin of the data: Not explicitly stated, but the manufacturer is based in the U.S. (San Diego, CA, U.S.A.), indicating the studies likely took place in the U.S.
- Retrospective or Prospective: Not explicitly stated, but the "samples obtained from women presenting for pregnancy testing" for the accuracy study suggests a prospective collection from a clinical setting. The Physicians' Office studies would also be 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: Not explicitly stated. However, for the accuracy study, the comparator was a "commercially available qualitative hCG test." The " Physicians' Office studies" involved "physician office personnel with diverse educational backgrounds and work experience," implying general healthcare workers capable of performing point-of-care tests.

4. Adjudication method for the test set:

Adjudication Method: Not explicitly stated. For the accuracy study, "a direct comparison of the test to a commercially available qualitative hCG test was conducted," implying the commercial test served as the reference or ground truth, rather than an explicit adjudication process for disagreements between human readers.

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

MRMC Study: No, this device is a rapid in vitro diagnostic immunoassay, not an AI-assisted diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable.
Effect Size: N/A (not an AI-assisted device).

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

Standalone Performance: Yes, in a sense. The QuickVue device itself is a standalone test that produces a result (presence or absence of a line) without continuous human interaction during the reaction phase, after the user adds the sample. The "accuracy exceeding 99%" was based on the device's output compared to a reference test. The "Physicians' Office studies" looked at how human users perform the standalone test accurately and reproducibly.

7. The type of ground truth used:

Type of Ground Truth: The primary ground truth for the accuracy study was the result from a "commercially available qualitative hCG test." This is a form of reference standard comparison against an accepted predicate device.
For the precision and consistency studies, the ground truth would be expected values, which implies a controlled laboratory setting (e.g., gravimetric or volumetric standards, or established reference materials).

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set in that sense. The "training" in the context of this immunoassay would be the internal development and optimization of the assay components and parameters.

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

Ground Truth for Training Set: Not applicable, as it's not an AI device. The development process would involve extensive experimentation and quality control against known positive and negative hCG samples with established concentrations to optimize sensitivity, specificity, and other analytical performance characteristics.

Summary

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16202799

SUMMARY OF SAFETY AND EFFECTIVENESS XI.

Product:

QuickVue® One-Step hCG-Urine

Manufacturer:

Quidel Corporation 10165 McKellar Court San Diego, California 92121 U.S.A.

Device Classification:

The device, QuickVue One-Step hCG-Urine, is similar to other FDA-cleared devices used for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in serum, plasma or 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. This 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 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.

Principle of the Test:

Urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.

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Safety and Effectiveness:

Numerous studies were undertaken to document the performance characteristics and the Numbrous studios from of the test to other commercially available products for the qualitative detection of hCG in urine. These studies included the following:

The test was shown to be similar to other commercially distributed in vitro tests in terms of 1. features and intended use.
1. The test was shown to have excellent intra- and inter-assay precision.
1. 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 4. performance.
1. Using samples obtained from women presenting for pregnancy testing, a direct comparison of the test to a commercially available qualitative hCG test was conducted in a multi-center field clinical trial. An accuracy exceeding 99% was observed.
1. Physicians' Office studies were conducted to demonstrate that physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.

Conclusion:

These studies demonstrated the substantial equivalence of the QuickVue One-Step hCG-Urine test to currently marketed devices which have been reviewed and cleared through the 510(k) notification process. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

MAY 1 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jennifer S. Hankard Regulatory Affairs Manager Quidel Corporation 10165 McKellar Court San Diego, CA 92121

K020799 Re:

Trade/Device Name: QuickVue® One-Step hCG-Urine Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 11, 2002 Received: March 12, 2002

Dear Ms. Hankard:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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" (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 Butman

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 (Separate Page): XIII.

Page	1 of 1
510(k) Number (if known):	K020799
Device Name:	QuickVue One-Step hCG-Urine

Indications for Use:

The QuickVue One-Step hCG-Urine is a one-step immunoassay intended for the qualitative The Quick de One Olino to Grino to the early detection of pregnancy. The test is intended for use by health care professionals.

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020799

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(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.