CARESTART HCG ONE-STEP PREGNANCY TEST

• K Number: K031052
• Device Name: CARESTART HCG ONE-STEP PREGNANCY TEST
• Manufacturer: ACCESS BIO INCORPORATE
• Date Cleared: 2003-06-13 ( 72 days)
• Product Code: DHA , JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Not Found

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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Information about any MRMC comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. 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.

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.