CARESTART HCG ONE-STEP PREGNANCY TEST by ACCESS BIO INCORPORATE

CareStanTM hCG One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Device Description

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AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a pregnancy test, which states that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions:

Device Name: CareStart™ hCG One-Step Pregnancy Test and CareStart Plus - hCG One-Step Pregnancy Test
Regulation Number: 21 CFR 862.1155 (Human chorionic gonadotropin (HCG) test system)
Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, intended for use by health care professionals.

However, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance.
Number or qualifications of experts used to establish ground truth.
Adjudication method.
Information about any MRMC comparative effectiveness study or its effect size.
Whether a standalone performance study was done.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How the ground truth for the training set was established.

This kind of detailed study information is typically found in the "Summary of Safety and Effectiveness" or a similar document that would have been submitted as part of the 510(k) application, but it is not present in the provided FDA clearance letter itself.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JUL 1 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Young Ho Choi Director Access Bio, Inc. 675 U.S. Highway 1 North Brunswick, NJ 08902

Re: K031052 Trade/Device Name: CareStart™ hCG One-Step Pregnancy Test CareStart Plus - hCG One-Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 31, 2003 Received: April 16, 2003

Dear Mr. Young Ho Choi:

This SE letter corrects the earlier letter stamp dated June 13, 2003. The name of the device had the word Combo in the wording for the name. It has now been removed from the Device Name.

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

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Applicant: Access Bio Inc.

510(k) Number (if known): New Application

Device Name: CareStart™ hCG One-Step Pregnancy Test CareStart Plus- hCG One-Step Pregnancy Test

Indications For Use:

Tan Coggm
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031052

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ( -

Over-The-Counter Use(

(Per 21 CFR 801.109)

(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.