The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or 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 serum or urine. Serum or 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 QuickVue® One-Step hCG-Combo device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Similar to other commercially distributed in vitro tests in terms of features and intended use.	Yes
Excellent intra- and inter-assay precision	Yes
Reproducibly manufacturable (Lot-to-lot consistency)	Yes
Common drugs, chemicals, and biologicals do not interfere with performance.	Yes
Accuracy exceeding 99% compared to a commercially available qualitative hCG test.	>99% accuracy
Physician office personnel with diverse educational backgrounds and work experience (intended users) can perform the test accurately and reproducibly.	Yes

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "samples obtained from women presenting for pregnancy testing."
- Data Provenance: Not explicitly stated, but given the manufacturer is a U.S. company (Quidel Corporation, San Diego, CA), it is likely the data originated from the U.S. The studies were likely prospective as they involved "women presenting for pregnancy testing" and "Physicians' Office studies" to assess performance in real-world settings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study compared the device to a "commercially available qualitative hCG test." It's reasonable to infer that the ground truth was established by the results of this comparative method, which would themselves be interpreted by trained laboratory personnel or healthcare professionals. The document does not provide details on the qualifications of such individuals for establishing ground truth but references that the device is "intended for use by health care professionals."
Adjudication method for the test set:
- Not described. The comparison was direct, suggesting the results of the QuickVue device were compared against the established results of the predicate device.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- Yes, indirectly. The "Physicians' Office studies" can be considered a form of MRMC study. These studies demonstrated that "physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly."
- Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a rapid immunoassay kit, not an AI-powered diagnostic tool. The "human readers" (physician office personnel) are performing the test and interpreting the visual result, not being assisted by AI. The study simply confirms they can do this accurately.
If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Yes. The primary performance characteristic of "accuracy exceeding 99%" was observed in a "direct comparison of the test to a commercially available qualitative hCG test." This refers to the standalone analytical performance of the device itself.
The type of ground truth used:
- Comparative Reference Standard: The ground truth was established by comparing the device's results to a "commercially available qualitative hCG test." This is a form of reference standard comparison, where the predicate device's results are considered the "truth." While not explicitly stated, it's highly probable that these commercial tests are themselves correlated with patient outcomes (pregnancy status confirmed by other clinical means, e.g., ultrasound, continued monitoring).
The sample size for the training set:
- Not applicable. This device is a rapid immunoassay, not a machine learning or AI algorithm requiring a specific "training set." The development of the device would involve R&D and optimization, but not in the sense of a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an immunoassay. The development process would involve internal validation and quality control measures to ensure the assay performs as intended.

Summary

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MAY 1 7 2002

KO20801

SUMMARY OF SAFETY AND EFFECTIVENESS XI.

Product: QuickVue® One-Step hCG-Combo

Manufacturer:

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

Device Classification:

Dovice, QuickVue One-Step hCG-Combo, is similar to other FDA-cleared devices used for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine. The test is the qualitative ustomor 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 serum or 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 mlU/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:

Serum or 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 substantial equivalence of the test to other commercially available products for the qualitative detection of hCG in serum or 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. JUsing samples obtained from women presenting for pregnancy testing, a direct comparison of the test to a commercially available qualitative hCG test was conducted. 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-Combo 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 stylized eagle with three stripes representing health, human services, and the U.S. population. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 7 2002

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

Re: K020801

Trade/Device Name: QuickVue® One-Step hCG-Combo 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 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 (Separate Page): XIII.

Page	1 of 1
510(k) Number (if known):	K020801

Device Name:

QuickVue® One-Step hCG-Combo

Indications for Use:

Dlen Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Numbe

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.