The Advantage hCG Test (Urine/Serum) is a qualitative, rapid immunochromatographic assay used to detect the presence of hCG in human urine and serum for the early detection of pregnancy. The test is intended for use in clinical laboratories by health care professionals.

Device Description

The Advantage hCG Test (Urine/Serum) is an immunochromatographic based one step in vitro test.

AI/ML Overview

The Advantage Diagnostics Corporation Advantage hCG Test (Urine/Serum) is an immunochromatographic assay designed for the qualitative detection of hCG in human urine and serum as an early indication of pregnancy.

Here's an analysis of its acceptance criteria and the study proving its performance:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Demonstrate substantial equivalence in performance characteristics to a legally marketed predicate device (PS-Unit Cassette/Serum and Urine Combo HCG by International Newtech Development, Inc.).	100% correlation with the predicate device.
Detect hCG in serum and urine at concentrations of 20 ng/mL or greater.	Detects hCG in serum and urine at 20 ng/mL or greater. (vs. predicate device "greater than 20ng/mL")
Demonstrate similar sensitivity, specificity, and accuracy to the predicate device.	100% correlation with the predicate device, implying similar sensitivity, specificity, and accuracy.

Study Details

Sample size used for the test set and the data provenance:
- Serum samples: 100 samples (51 positive and 49 negative)
- Urine samples: 105 samples (40 positive and 65 negative)
- Data Provenance: The document does not explicitly state the country of origin. It is implied to be clinical samples from pregnant and non-pregnant women. The study appears to be retrospective, as it describes the evaluation of existing samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth. The ground truth appears to be based on the established pregnancy status of the women from whom the samples were collected.
Adjudication method for the test set:
- The document does not describe an adjudication method. It states that the samples were evaluated and compared, implying a direct comparison of results between the test device and the predicate device, against known pregnancy status.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device in detecting hCG and its correlation with a predicate device, rather than the impact of the device on human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The Advantage hCG Test is an in-vitro diagnostic device (immunochromatographic assay), meaning its performance is evaluated based on its ability to detect the analyte (hCG) in samples, independent of human interpretation beyond reading the test result itself. The study compared the device's results directly with a predicate device and the known status of the samples.
The type of ground truth used:
- The ground truth was based on the known pregnancy status of the women from whom the urine and serum samples were collected (i.e., "pregnant and non pregnant women"), along with the results from the predicate device. While not explicitly stated as "clinical outcomes data," the known pregnancy status serves as the ultimate clinical ground truth for hCG detection.
The sample size for the training set:
- The document does not mention a training set as this is an in-vitro diagnostic device (immunochromatographic assay) and likely does not involve machine learning algorithms that require separate training and test sets in the traditional sense. The study described is a performance evaluation or validation study.
How the ground truth for the training set was established:
- As no training set is mentioned or applicable in the context of this device technology, the method for establishing its ground truth is not applicable.

Summary

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3 2000 FEB

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is K994227

Date of summary: January 31, 2000

Advantage Diagnostics Corporation 2. Submitted by: 2440 Leghorn Street Mountain View CA, 94043
Advantage hCG Test (Urine/Serum) 3. Device Name:

Device Classification: Class II, 862.1155 Product Code JHI
Device description: The Advantage hCG Test (Urine/Serum) is an immunochromatographic based one step in vitro test.
Intended Use: The test is designed for the qualitative detection of hCG in human unine and serum as an early indication of pregnancy. This test is for use in clinical laboratories by health care professionals.
Substantial Equivalence: The Advantage hCG Test (Urine/Serum) was found substantially equivalent to the PS-Unit Cassette/Serum and Urine Combo HCG manufactured by International Newtech Development, Inc. Both products are immunoassays and use specific antibodies to detect the hQG in human urine and serum. The sensitivity of the tests are similar, the Advantage hCG Test detects hCG in serum and urine, at 20ng/mL or greater while the prodicate device detects hCG in serum and urine at concentrations greater than 20ng/mL. The tests demonstrated 100% correlation when 100 serum (51 positive and 49 negative) and 105 urine samples (40 positive and 65 negative) from pregnant and non pregnant women were evaluated and compared. The tests are similar in sensitivity, specificity and accuracy.

Conclusion:

The Advantage hCG Test (Urine /Serum) and the PS-Unit Cassette/Serum and Urine Combo HCG are substantially equivalent in performance characteristics. The correlation of the two tests was 100%.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a person with outstretched arms, composed of three curved lines. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. The text is in uppercase letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 3 2000

Ms. Janis Freestone Director, Regulatory Affairs Advantage Diagnostics Corporation 2440 Leghorn Street Mountain View, California 94043

Re: K994227

Trade Name: Advantage hCG Test (Urine/Serum) Regulatory Class: II Product Code: JHI Dated: December 3, 1999 Received: December 15, 1999

Dear Ms. Freestone:

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 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). 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 (Premarket Approval), 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 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 regulations.

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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 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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510k Number: K994227

Device Name: Advantage hCG Test (Urine/Serum)

Indications for Use:

Jean Cooper.

(Division Sign-Off)
Division of Clinical Laboratory Levices

510(k) Number K994227

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.