The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Device Description

The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories. The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

AI/ML Overview

Here's an analysis of the Genzyme Contrast® II hCG Urine/Serum Test based on the provided text, focusing on the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Genzyme Contrast® II hCG Urine/Serum Test are implicitly tied to demonstrating substantial equivalence to the predicate device, the Quidel QuickVue® One-Step hCG Combo Test, particularly in analytical sensitivity and overall agreement.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (Contrast® II hCG Urine/Serum Test)
Analytical Sensitivity	Urine: Equal to or better than predicate (20 mIU/mL) Serum: Equal to or better than predicate (10 mIU/mL)	Urine: 20 mIU/mL Serum: 10 mIU/mL
Overall Agreement	High agreement with predicate device (Quidel QuickVue® One-Step hCG Combo Test) for both positive and negative results.	In a study of 201 urine samples and 319 serum samples, the Contrast® II hCG Urine/Serum Test showed agreement with the currently marketed qualitative hCG assay (predicate) with the exception of two discrepant samples. One urine sample (2.6 mIU hCG/mL) and one serum sample (0 mIU hCG/mL) were positive by the predicate but negative by the Contrast® II. The quantitative assay re-testing supported the Contrast® II results for these two samples. This suggests high overall agreement, with the discrepancies being resolved in favor of the Contrast® II's accuracy.
Intended Use Equivalence	Qualitative detection of hCG in urine or serum for early pregnancy detection, usable in physicians' offices and clinical laboratories.	The device is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy, for use in physicians' offices and clinical laboratories.

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

Test Set Sample Size:
- 201 urine samples
- 319 serum samples
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "samples," which implies they were collected for the study, but the precise nature of the collection is not detailed.

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

The ground truth for the test set was not established by human experts in the traditional sense. The "ground truth" was determined by comparison to a legally marketed predicate device (Quidel QuickVue® One-Step hCG Combo Test) and, for discrepant samples, a quantitative reference assay (Diagnostics Products Coat-A-Count® hCG IRMA). Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied to image-based diagnostics or clinical diagnoses is not directly applicable here.

4. Adjudication Method for the Test Set

The adjudication method involved:

Initial comparison to the predicate device.
For discrepant samples (where the Contrast® II and predicate results differed), a third, quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) was used to resolve the discrepancy. This can be viewed as a form of third-party arbitration/resolution using a more definitive method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) based on an immunoassay, not an imaging device or a diagnostic requiring human interpretation of complex visual data. Therefore, the concept of "human readers" and improved performance with or without AI assistance is not relevant to this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study effectively represents a standalone performance of the Contrast® II hCG Urine/Serum Test. The device itself is designed to provide a direct visual result (bands) without requiring complex human interpretation or an AI algorithm. The study assesses the device's ability to accurately detect hCG in samples on its own, compared to other established methods.

7. The Type of Ground Truth Used

The ground truth for the test set was established using a hierarchical approach:

Predicate Device Comparison: Initial agreement was assessed against the Quidel QuickVue® One-Step hCG Combo Test.
Quantitative Assay: For discrepant samples, the Diagnostics Products Coat-A-Count® hCG IRMA (a quantitative assay) served as the definitive ground truth, providing a more precise measurement of hCG levels.

8. The Sample Size for the Training Set

The document does not specify a training set size. IVD devices like this typically undergo extensive R&D and optimization during development, often using numerous samples for analytical characterization and calibration. However, the 510(k) summary focuses on the clinical performance study (test set) for demonstrating substantial equivalence, not the internal development process that might involve a "training set."

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

Since a dedicated "training set" with ground truth establishment in the context of machine learning is not discussed, this question is not applicable to the provided information. The development of such an immunoassay relies on established biochemical principles and extensive internal validation, rather than a formal machine learning training paradigm with independently adjudicated ground truth for a "training set."

Summary

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510(k) SUMMARY

JAN 1 6 2003

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the Contrast® II hCG Urine/Serum test.

1. Sponsor/Applicant Name and Address:
  Genzyme Corporation One Kendall Square Cambridge, MA 02139
1. Sponsor Contact Information:
  E.V. Goorchenko Associate Director, Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com
1. Date of Preparation of 510(k) Summary: October 21, 2002
1. Device Trade or Proprietary Name:

Contrast® II hCG Urine/Serum Test

1. Device Common/Usual or Classification Name:
  hCG Test System
1. Legally Marketed Devices to which Equivalence is Being Claimed:
  Quidel QuickVue® One-Step hCG Combo Test (K 020801)

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7. Device Description

Intended Use

Principle of the Device

The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).

The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

8. Comparison of Technological Characteristics of Genzyme Contrast® II hCG Urine/Serum Test with Legally Marketed Device:

The similarities with, and differences between, the Contrast® II hCG Urine/Serum test and the Quidel One-Step device are described in Table 1.

Agreement with Predicate Device: 9.

A total of 201 urine samples and 319 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. When tested according to the instructions and limits in the package inserts, the results obtained with the different assays were in agreement with the exception of two discrepant samples. One urine sample and one serum sample produced positive responses with the QuickVue® One-Step Combo hCG test while the Contrast® II Urine/Serum test produced negative results for those samples. The discrepant samples were tested

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with a quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) and found to contain 2.6 mIU hCG/mL in the urine sample and 0 mIU hCG/mL in the serum sample.

	Genzyme Contrast® II hCGUrine/Serum Test	QuidelQuickVue® hCG-Combo Test
Assay Format	Lateral flow immunoassay	Lateral flow immunoassay
Result Format	Visible lines:Negative=one gray or blackControl LinePositive=one gray or blackControl Line and one gray orblack Test Line	Visible lines:Negative =blue proceduralControl LinePositive = one pink-to-purpleTest Line and one blue ControlLine
Specimen	Urine or Serum	Urine or Serum
Antibodies	Mouse monoclonal andgoat polyclonal	Mouse monoclonal andgoat polyclonal
Internal Control	Yes	Yes
TimeToResult	Urine: Read result at 3minutesSerum: Read result at 5 or 7minutes	Urine: Read result at 3 minutesSerum: Read result at 5minutes
Analytical Sensitivity	Urine: 20 mIU/mLSerum: 10 mIU/mL	Urine: 20 mIU/mLSerum: 10 mIU/mL

Table 1. Summary of Device Similarities and Differences

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 6 2003

Mr. E. V. Goorchenko Associate Director, Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, MA 02139

Re: K023544

Trade/Device Name: Contrast ® II hCG Urine/Serum Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: October 21, 2002 Received: October 22, 2002

Dear Mr. Goorchenko:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: New Application Ko23544

Device Name :

Contrast® II hCG Urine/Serum Test

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

k) Number K023544

✓

Prescription Use (Per 21 CRF 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.