The QuickVue® Semi-Q hCG-Combo is a one-step immunoassay intended for the semi-quantitative detection of human chorionic gonadotropin (hCG) in serum and the qualitative detection of hCG in urine for the early detection of pregnancy. The QuickVue Semi-Q hCG-Combo is intended for use by health care professionals.

Device Description

The test is a rapid immunoassay for the semi-quantitative detection of hCG in serum and the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy. 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-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear. Serum results are interpreted by comparing the color development of the Test Line with a Reference Line. Serum results are reported as negative, positive less than 25 mIU/ml or positive greater than 25 mIU/mL. Urine results are interpreted as negative or positive.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QuickVue® Semi-Q hCG-Combo, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy (compared to predicate)	High accuracy (e.g., >95% or >99%)	"An accuracy exceeding 99% was observed."
Intra-assay precision	Excellent precision	"The test was shown to have excellent intra- and inter-assay precision."
Inter-assay precision	Excellent precision	"The test was shown to have excellent intra- and inter-assay precision."
Lot-to-lot consistency	Reproducibility across lots	"Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable."
Interference	No interference from common substances	"Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance."
Usability by healthcare professionals	Accurate and reproducible results by typical users	"The results obtained at each site agreed 100% with the expected results." (In Physician's Office Laboratory studies)

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated as a single number for each study. However, the accuracy study used "serum and urine samples obtained from women presenting for pregnancy testing." The Physician's Office Laboratory (POL) study used an unspecified number of samples where "The results obtained at each site agreed 100% with the expected results."
Data Provenance: The POL studies were conducted at "three geographically distinct sites in the United States." The provenance of the samples for the accuracy study is not specified beyond "women presenting for pregnancy testing." The studies are retrospective as they are comparing against an already existing predicate device.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated for either the accuracy study or the POL study.
Qualifications of Experts: For the POL studies, the users were "doctor's office personnel with diverse educational backgrounds and work experience." This implies typical healthcare professionals who would use such a test in a clinical setting, rather than specialized experts establishing a technical ground truth. For the predicate device (Hybritech® ICON® II HCG ImmunoConcentration™ Assay), the "ground truth" would be the result from that device, which is presumably established via its own validation.

4. Adjudication Method

Adjudication Method: Not explicitly mentioned. In the context of a direct comparison to a predicate device, the predicate's result itself often serves as the reference, implying no separate adjudication process beyond the predicate's inherent result. For the POL studies, "expected results" were used, suggesting a pre-determined or known outcome for the samples, rather than a dynamic adjudication process by experts.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how human readers improve with AI vs without AI assistance. This device is a rapid immunoassay, a diagnostic test where the output is directly interpreted (presence/absence of line for urine, comparison to reference line for serum), rather than an imaging or complex algorithm requiring human-in-the-loop assistance in the sense of AI.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: Yes, the studies described are essentially standalone performance studies of the device itself.
- The "direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay" demonstrates the device's performance (algorithm/system only) against a known standard.
- The intra- and inter-assay precision, lot-to-lot consistency, and interference studies are all evaluations of the device's intrinsic standalone performance.

7. Type of Ground Truth Used

Type of Ground Truth:
- For the accuracy study, the ground truth was based on the results of a predicate device: the "Hybritech® ICON® II HCG ImmunoConcentration™ Assay for hCG detection."
- For the Physician's Office Laboratory studies, the ground truth was "expected results," indicating that the samples used likely had known hCG statuses (e.g., positive or negative based on prior testing or clinical knowledge).

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. As this is a rapid immunoassay, the concept of a "training set" in the context of machine learning algorithms is not directly applicable in the same way. The development and optimization of such a test involve various R&D processes, but not typically a labeled "training set" for an AI algorithm.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable in the context of an AI training set. For an immunoassay, the "ground truth" for development and optimization would stem from established biochemical principles, known concentrations of hCG, and comparisons to reference methods, ensuring the test reagents and design accurately detect hCG.

Summary

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K974052

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XI.

Product:

QuickVue® Semi-Q hCG-Combo

Manufacturer:

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

Device Classification:

The device, QuickVue Semi-Q hCG-Combo, is similar to other FDA-cleared devices used for the detection of human chorionic gonadotropin (hCG) in serum or 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 semi-quantitative detection of hCG in serum and 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.

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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-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.

Serum results are interpreted by comparing the color development of the Test Line with a Reference Line. Serum results are reported as negative, positive less than 25 mIU/ml or positive greater than 25 mIU/mL. Urine results are interpreted as negative or positive.

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 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 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 serum and urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for 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 QuickVue Semi-Q hCG-Combo to existing products already marketed. They further demonstrated the suitability of the product for use by health care Such studies are a critical element in establishing the professionals. 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top and bottom of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 1997

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

K974052 Re : QuickVue® Semi-Q hCG-Combo Requlatory Class: II Product Code: JHI Dated: October 24, 1997 Received: October 27, 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, 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, qood 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 requlations 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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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Page _________________________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device. Name:

OuickVue® Semi-Q hCG-Combo

Indications for Use:

UMichael for A. Montgomery

(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_

(Optional Format 1-2-96)

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.