The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

Device Description

Human Chorionic Gonadotropin (hCG) test system for the use in early detection of pregnancy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Bayer Diagnostics Clinitest® hCG Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for this device appears to be its ability to accurately detect hCG at a specific concentration and differentiate between various hCG levels, particularly around the 25 mIU/mL cutoff.

Acceptance Criteria	Reported Device Performance
Sensitivity: Detect hCG at 25 mIU/mL	The device detects urinary hCG at 25 mIU/mL.
Accuracy (Agreement with Commercial Assay): 100% agreement with a commercial hCG immunoassay at tested concentrations (0, 25, 100 mIU/mL)	100% agreement with the commercial hCG assay (ADALTIS Italia immunoradiometric assay) was observed for samples at 0, 25, and 100 mIU/mL.

Study Details

2. Sample Size and Data Provenance

Test Set (Sensitivity Study):
- Sample Size: 280 samples (20 samples per hCG concentration level across 7 levels x 2 product lots). Each sample was blind-labeled and tested.
- Data Provenance: The samples were prepared in-house by spiking negative urine (from 4 donors) with hCG standard. This suggests laboratory-controlled, prospective data generation rather than retrospective patient data.
Test Set (Accuracy Study):
- Sample Size: 200 visual test results (68 samples at 0 mIU/mL, 66 at 25 mIU/mL, 66 at 100 mIU/mL).
- Data Provenance: The samples were prepared by pooling four urine specimens and spiking them with hCG, then tested at two external sites. This is also laboratory-controlled, prospective data.

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

Sensitivity Study: "Samples were randomly distributed among four visual readers for each product lot."
- Number of Experts: 4
- Qualifications: Not specified. It's likely they were trained laboratory personnel or similar, given the context of a professional-use device, but no specific professional titles (e.g., medical technologists, clinical laboratory scientists) or years of experience are listed.
Accuracy Study: For the Clinitest® hCG results, it states "visual test results," implying human readers.
- Number of Experts: Not explicitly stated how many individual readers performed the tests at the external sites, only that there were "two external sites."
- Qualifications: Not specified.

4. Adjudication Method for the Test Set

Sensitivity Study: The text mentions "four visual readers for each product lot" and then reports aggregate "Number of Positives" and "Number of Negatives." It does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It's possible that each reader's result contributed to the count, or a consensus was reached, but the specific process isn't detailed.
Accuracy Study: The results are reported as "Clinitest® hCG Visual Results" and "100% agreement of sample results with the commercial hCG assay." No specific reader adjudication process is detailed beyond the visual reading at two external sites.

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

No, this was not an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device itself is a qualitative invitro diagnostic test for visual reading, not an AI-powered diagnostic tool. The "readers" mentioned are simply individuals interpreting the visual test results.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire performance section describes the algorithm's (the test's) ability to detect hCG in urine samples independent of a human interpretation for comparison or assistance. The "visual readers" are the mechanism by which the device (algorithm) provides a result, not an interface for an AI. The device is intended to provide a visual result, and its performance is the standalone performance.

7. Type of Ground Truth Used

Sensitivity Study: The ground truth was established by spiking negative urine with known concentrations of hCG standard. This is a highly controlled, synthetic ground truth. The hCG standard itself is calibrated against WHO 3rd International Reference Preparation (IRP).
Accuracy Study: The ground truth for this study was established using a commercial hCG immunoassay (an immunoradiometric assay made by ADALTIS Italia). This is an external reference standard.

8. Sample Size for the Training Set

The document does not describe a training set in the context of machine learning or AI. This is a traditional immunoassay device, not an AI algorithm. Therefore, the concept of a "training set" for an AI model is not applicable here.

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

As there is no mention of an AI algorithm or a training set, this question is not applicable to the provided information.

Summary

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K023944

Summary of Safety and Effectiveness

FEB 1 1 2003

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitter Information
  Contact person: Thomas F. Flynn

Baver Diagnostics Address: 63 North Street Medfield, MA 02052

Phone:	(508) 359-3877
FAX:	(508) 359-3356
e-mail:	thomas.flynn.b@bayer.com

2. Device Information

Proprietary Name:	Bayer Diagnostics Clinitest® hCG Pregnancy Test
Common Name:	An hCG test system is a device intended for earlydetection of Pregnancy. It is intended to measure hCG, aplacental hormone in urine.

Classification Name: Human Chorionic Gonadotropin (hCG) test system for the
use in early detection of pregnancy.

3. Predicate Device Information

SureStep™ hCG/Combo (II) Pregnancy Test Name:

4. Device Description

Human Chorionic Gonadotropin (hCG) test system for the use in early detection of pregnancy.

ട. Statement of Intended Use

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. Summary of Technological Characteristics

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is a one-step chromatographic immunoassav for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine. The test cut-off is 25 mlU/ml hCG in urine. The test device contains a membrane strip that was pre-coated with anti-hCG capture antibody on the test line region and goat anti-mouse IgG on the control band region. During testing, the patient specimen is allowed to react with the colloidal gold particles that have been coated with anti-hCG monoclonal antibody. The mixture then moves along or across the membrane chromatographically by capillary action. For a positive result, a colored band with a specific anti-hCG-antibody-colloidal gold particle complex will form on the membrane in the test region. A strong colored line will always appear in the control region and another light colored line will always appear in the reference region. The color intensity of the reference line has been adjusted to a level of approximately 25 mlU/ml hCG. Comparison of the test line intensity to the reference line intensity will allow the estimation of whether the positive results are less than, equal to or greater than 25 mlU/ml hCG in serum.

7. Performance Data

Sensitivity

The Bayer Diagnostics Clinitest® hCG Pregnancy Test detects urinary hCG concentrations at 25 mlU/mL (Calibrated against WHO 310 IRP).

A sensitivity study was performed by spiking negative urine. medium specific gravity with hCG standard to the concentrations of 0, 5, 10, 15, 20, 25 and 50 miU/mL. The urine pool was prepared from 4 donors. The samples were blindlabeled and tested with the Clinitest® hCG Pregnancy Test using two different validation lots of product. A total of 280 samples were tested. Samples were randomly distributed among four visual readers for each product lot.

hCG ConcentrationmlU/mL	0	5	10	15	20	25	50
N =	20	20	20	20	20	20	20
Number ofPositives	0	5	9	13	15	18	20
Number ofNegatives	20	15	11	7	5	2	0

Clinitest hCG Lot 1 N=140

Clinitest hCG Lot 2 N=140

hCG ConcentrationmIU/mL	0	5	10	15	20	25	50
N =	20	20	20	20	20	20	20
Number ofPositives	0	3	9	10	13	19	20
Number ofNegatives	20	17	11	10	7	1	0

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Accuracy

Two external sites were contracted to perform testing on the Clinitest® hCG test (validation lot 59421). A total of 200 visual test results were obtained. Site one tested 98 samples and site 2 tested 102 samples. The samples were prepared by pooling four urine specimens of medium specific gravity, aliquoting and spiking with hCG. The samples were divided by site.

Sample	Site 1	Site 2	Total
0 mlU/mL Lablot # 1	33	35	68
25 mlU/mL Lablot # 2	33	33	66
100 mlU/mL Lablot # 3	32	34	66
			200

Clinitest® hCG Visual Results

The results of the Clinitest® hCG external site data compared to a commercial hCG assay results The commercial assay was an immunoradiometric assay (Magnetic Solid Phase) made by ADALTIS Italia, purchased through Polymedco, Inc. There was 100% agreement of sample results with the commercial hCG assay.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 1 2003

Mr. Thomas F. Flynn Director of Regulatory Affairs Bayer Diagnostics Baver Corporation 63 North Street Medfield, MA 02052-1688

Re: K023944

Trade/Device Name: Bayer Diagnostics Clinitest® hCG Pregancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: November 21, 2002 Received: November 26, 2002

Dear Mr. Flynn:

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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Page 2 -

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). You may obtain other general information on your responsibilities under the Act 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K.O. 2394

Device Name:

Indications for Use:

Jlan Coogen

(Division Sign-Off)

Division of Clinical Labora 510(k) Number -

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter

(Optional

Use (Per 21 CFR 801.109) 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.