ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

• K Number: K050305
• Device Name: ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
• Manufacturer: BIOSCREEN MEDICAL INC.
• Date Cleared: 2005-05-23 ( 104 days)
• Product Code: LCX , JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

One Step hCG Pregnancy Urine Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip, cassette and midstream formats are intended for overthe-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.

One Step hCG Pregnancy Urine/Serum Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for the Bioscreen Medical Inc. One Step hCG Pregnancy Urine Test and One Step hCG Pregnancy Urine/Serum Test. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication as requested in the prompt.

Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory approval and indications for use.

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.