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K Number
K974425
Device Name
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1997-12-24

(30 days)

Product Code
DHA
Regulation Number
862.1155
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to fill out all the sections of your request about acceptance criteria and study particulars for the BioSign™ hCG-One Step Pregnancy Test. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not typically include the nitty-gritty details of the studies conducted to demonstrate performance.

Here's what I can and cannot extract from the given text:

Information I CANNOT extract from the document:

  • Acceptance Criteria Table and Reported Device Performance: This document does not specify exact acceptance criteria or detailed performance metrics like sensitivity, specificity, accuracy, or reported values from a study.
  • Sample Size (Test Set) and Data Provenance: This information is not present.
  • Number of Experts and Qualifications: Not mentioned in this regulatory letter.
  • Adjudication Method: Not specified.
  • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study and its results are not discussed.
  • Standalone Performance: While the device is "one-step," the specific details of a standalone performance study with metrics are not included.
  • Type of Ground Truth Used: The method for establishing ground truth (e.g., pathology, expert consensus) is not detailed.
  • Sample Size (Training Set): Not provided.
  • How Ground Truth for Training Set was Established: Not provided.

What I can infer/extract at a high level:

  • Device Name: BioSign™ hCG-One Step Pregnancy Test
  • Indications for Use: Immunoassay for in vitro diagnostic use in hospitals and physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) for the early confirmation of pregnancy.
  • Ground Truth (Indirect Inference): For a pregnancy test, the ground truth would typically be established by a reference method for hCG detection (e.g., a laboratory quantitative hCG assay) or confirmed clinical pregnancy outcomes, but the document doesn't explicitly state which was used.
  • Regulatory Context: This is a 510(k) premarket notification, indicating the device was cleared based on substantial equivalence to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics, or if different, that the differences do not raise new questions of safety or effectiveness. Performance data would have been submitted to support this claim, but those details are not in this letter.

To get the information you requested, you would typically need to refer to the 510(k) submission summary or detailed performance data submitted by Princeton BioMeditech Corporation to the FDA, which is not part of this clearance letter.

§ 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.