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 QuickVue One-Step hCG-Combo 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. 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.

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:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" for accuracy, precision, or other measures as a predetermined threshold that must be met. Instead, it describes performance characteristics and comparisons to establish substantial equivalence.

Based on the information provided, here's a table summarizing the performance aspects:

Performance Characteristic	Reported Device Performance
Accuracy (compared to predicate)	Exceeding 99% accuracy when compared to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection.
Intra-Assay Precision	"Excellent" intra-assay precision.
Inter-Assay Precision	"Excellent" inter-assay precision.
Lot-to-Lot Consistency	"Reproducibly manufacturable."
Interference	Common drugs, chemicals, and biologicals were shown "not to interfere with the test's performance."
Usability (Physician's Office Lab)	Doctor's office personnel with diverse backgrounds could perform the test accurately and reproducibly. Results agreed 100% with expected results at three distinct U.S. sites.

2. Sample Size and Data Provenance

Test Set Sample Size: Undisclosed. The document states "samples obtained from women presenting for pregnancy testing" were used for the direct comparison study.
Data Provenance:
- Direct Comparison Study: Samples were "obtained from women presenting for pregnancy testing." The specific country of origin is not stated, but given FDA submission, it's highly probable the study was conducted in the U.S.
- Physician's Office Laboratory Studies: Conducted at "three geographically distinct sites in the United States."
- Retrospective or Prospective: Not explicitly stated, but the phrasing "samples obtained from women presenting for pregnancy testing" suggests these were likely prospective or collected contemporaneously with the study. The Physician's Office Lab studies appear to be prospective.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method (Test Set)

Not explicitly described. The comparison was made "to the Hybritech ICON II HCG ImmunoConcentration Assay," which served as the reference standard. This implies independent determination by the predicate device as the ground truth, rather than human expert adjudication of agreement between the two tests.

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

No, an MRMC comparative effectiveness study was not done. The studies focused on the performance of the device itself, either in comparison to a predicate device or by laboratory personnel, rather than measuring the improvement of human readers (clinicians) with or without AI assistance. This device is an in-vitro diagnostic, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was conducted. The "accuracy exceeding 99%" reported for the comparison against the Hybritech ICON II HCG ImmunoConcentration Assay represents the standalone performance of the QuickVue One-Step hCG-Combo device. The Physician's Office Laboratory studies also demonstrated the device's standalone performance when used by varied personnel.

7. Type of Ground Truth Used

For Accuracy Study: The ground truth was established by a predicate device, specifically the "Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection." This assay itself would have its own established ground truth (likely clinical diagnosis or another gold standard for hCG detection).
For Usability (Physician's Office Lab) Study: The ground truth was "expected results," which would be based on known positive and negative hCG samples or clinical diagnoses.

8. Sample Size for the Training Set

Not applicable / Not disclosed. This device is a rapid immunoassay, a chemical and biological test system, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" and "optimization" phase of such a device would involve extensive testing and validation, but not typically a "training set" as understood in AI/ML contexts.

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

Not applicable. As mentioned above, there isn't a "training set" in the AI/ML sense for this type of immunoassay. The development and validation would involve biochemical principles and rigorous quality control rather than machine learning training.

Summary

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15-112341

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XI.

DEC - 1 1997

Product:

OuickVue® One-Step hCG-Combo

Manufacturer:

QUIDEL Corporation 10165 McKellar Court San Diego, CA 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 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 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 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.

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 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 samples obtained from women presenting for pregnancy testing, a direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay 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 QuickVue One-Step hCG-Combo 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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, stacked on top of each other. The figure is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 1 1997

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

Re : K973841 QuickVue® One-Step hCG-Combo Requlatory Class: II Product Code: JHI October 7, 1997 Dated: Received: October 8, 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 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 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 findinq 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 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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K973841

Device Name:

QuickVue® One-Step hCG-Combo

Indications for Use:

(IPLEASE 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 vice

510(k) Number	973841
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Prescription Use (Per 21 CFR 801.109)		OR	Over-The Counter Use
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(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.