The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.

Device Description

The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.

AI/ML Overview

This document describes a 510(k) premarket notification for the Clinitest® hCG Pregnancy Test. The information provided focuses on the device's substantial equivalence to predicate devices and general regulatory information, rather than a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth specifics for training) cannot be extracted from the provided text. The document is a regulatory submission summary, not a full study report.

However, I can extract the following based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics (like sensitivity, specificity, or accuracy) or report specific device performance values in a table. It only states that the device has "similar technological characteristics, device performance and intended use" to its predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria in the provided text. The overarching "acceptance criterion" from a regulatory perspective is "substantial equivalence" to predicate devices.	The document states the device has "similar technological characteristics, device performance and intended use" as the predicate devices. It provides no specific numerical performance data (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance

Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a rapid diagnostic test read by an instrument (Clinitek Status analyzer), not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device, when read by the Clinitek Status instrument, operates in a "standalone" manner for interpreting the test result (positive, borderline, or negative). However, the document does not provide a standalone performance study report with specific metrics. It simply describes the device's function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided in the document. For pregnancy tests, ground truth typically involves confirmation with a more definitive method (e.g., quantitative hCG measurement, clinical outcome).

8. The sample size for the training set

Not applicable/Not provided. This is a point-of-care rapid diagnostic test, not an AI/machine learning device that would typically have a "training set" in the computational sense. The "training" for such devices usually refers to manufacturing process development, reagent optimization, and internal verification/validation, not a dataset for algorithm training.

9. How the ground truth for the training set was established

Not applicable/Not provided (as per point 8).

Summary

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K032563

DEC 2 3 2003

Appendix A Summary of Safety and Effectiveness

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

1. Submitters Information

Contact person:	Mary E. Gray, RACNPT Regulatory Affairs Manager
Address:	Bayer Healthcare, LLCSubsidiary of Bayer Corporation63 North StreetMedfield, MA 02052
Phone:	(508) 359-3826
Fax:	(508) 359-3776 or (508) 359-3356
e-mail address:	mary.gray.b@bayer.com
Date Summary Prepared:	November 7, 2003
2. Device Information

〜に〜it

Proprietary Name:	Clinitest® hCG Pregnancy Test
Common Name:	hCG Test System
Classification Name:	Radioimmunoassay, Human Chorionic Gonadotropin
Classification Number:	21 CFR 862.1155, Class II
Classification Panel:	Clinical Chemistry and Clinical Toxicology

3. Predicate Device Information

Device Name:	Clinitest hCG PregnancyTest	Quidel QuickVue One-StephCG Combo
Manufacturer:	Bayer Healthcare, LLC	Quidel Corporation
510(k)Number:	# K023944	# K020801

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Appendix A Summary of Safety and Effectiveness

4. Device Description

The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.

5. Statement of Intended Use

6. Summary of Technological Characteristics

The Clinitest hCG Pregnancy Test is similar in technological characteristics, device performance and intended use, therefore, is substantially equivalent to the predicate performanoo and intenace ass, nency Test (# K023944) and the Quidel QuickVue One-Step hCG Combo test (# K020801).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 2003

Ms. Mary E. Gray NPT Regulatory Affairs Manager Bayer Healthcare, LLC Subsidiary of Bayer Corporation 63 North Street Medfield, MA 02052

K032563 Re: Trade/Device Name: Clinitest® hCG Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: November 7, 2003 Received: November 10, 2003

Dear Ms. Gray:

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, 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 (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). 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 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K032563
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Bayer Healthcare Clinitest® hCG Pregnancy Test Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use a r he Bayer Fredit four of human chorionic gonadotropin (hCG) in unne qualitatio mother in used to obtain a Clinitek Status analyzer result of positive, borderline or negative and is intended for near patient (point-of-care) and centralized laboratory locations.

(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)

Carol C Benson

Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) /<032563

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.