CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY by ACCESS BIO INCORPORATE

CareStart™ 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 over-the counter sale to laypersons.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for the CareStart™ Pregnancy Test and CareStart PLUS™ Pregnancy Test. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive summary of safety and effectiveness (SSE).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I answer many of the specific questions about the study design, sample sizes, ground truth establishment, or expert qualifications.

The only information directly related to performance from this document is:

Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
Target User: Laypersons (over-the-counter sale).

To fully answer your request, a more detailed document, such as a 510(k) summary (which often contains safety and effectiveness data), would be required.

Based on the provided text, here's what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided as this information is not in the clearance letter. Acceptance criteria and specific performance metrics (like sensitivity and specificity at various hCG levels) are typically found in the clinical study report or 510(k) summary, not the clearance letter itself.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided as this information is not in the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Cannot be provided as this information is not in the clearance letter. (For a pregnancy test, ground truth would likely be established by a reference method measuring hCG levels, not typically by expert interpretation of the test result itself in a clinical study context for regulatory submission.)

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

Cannot be provided as this information is not in the clearance letter.

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 (pregnancy test), not an AI-assisted diagnostic imaging device or an AI application that would be used by human readers in an MRMC study.

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

Not applicable. This device is a rapid diagnostic test that provides a visual result for the user. It is inherently "standalone" in that it performs its function without a separate algorithm needing to be assessed for standalone performance. The "human-in-the-loop" here is the layperson interpreting the visual result.

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

Cannot be definitively stated from this document. For a pregnancy test, the ground truth for establishing performance is almost always a quantitative laboratory method (e.g., ELISA, RIA, or other highly sensitive and specific quantitative hCG assays) that measures the actual concentration of hCG in urine or serum, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Cannot be provided as this information is not in the clearance letter.

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

Cannot be provided as this information is not in the clearance letter. (As mentioned above, for pregnancy tests, it's typically based on quantitative laboratory hCG measurements.)

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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 U.S.A." arranged around the perimeter. Inside the circle is a stylized image of three overlapping, abstract shapes that resemble birds in flight.

SEP - 5 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

K032159 Re: Trade/Device Name: CareStart™ Pregnancy Test CareStart PLUSTM Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 25, 2003 Received: July 15, 2003

Dear Mr. Choi:

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). 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

Ver/ 3 - 4/24/96

Applicant: Access Bio Inc.

510(k) Number (if known): New Application - Ko3 2159

CareStart™ Pregnancy Test Device Name: CareStart PLUSTM Pregnancy Test

Indications For Use:

Carol C Benen for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032159

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (	)
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Over-The-Counter Use(	X )
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(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.