BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP

• K Number: K981444
• Device Name: BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 1998-07-22 ( 91 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physicians' offices for the detection of Human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy.

Device Description

Not Found

AI/ML Overview

The document provided is a 510(k) clearance letter from the FDA for a pregnancy test strip. It does not contain the detailed information necessary to complete a table of acceptance criteria and a study description as requested. The letter primarily states that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the given input. The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
3. Information on multi-reader multi-case studies or standalone algorithm performance.
4. Details on the type of ground truth used or how ground truth was established for training sets.
5. Sample size for any training set.

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.