E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

• K Number: K061769
• Device Name: E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
• Manufacturer: UNIPATH LTD.
• Date Cleared: 2006-07-03 ( 10 days)
• Product Code: LCX
• Regulation Number: 862.1155
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

e.p.t Certainty® 1-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for the e.p.t Certainty® 1-Step Pregnancy Test. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing or training sets.

To get this information, you would typically need to refer to the substantial equivalence documentation submitted by Unipath Ltd. to the FDA, which is not provided in this excerpt.

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.