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K Number
K992695
Device Name
INSURE PRO TEST
Manufacturer
INBIOS INTL., INC.
Date Cleared
1999-10-18

(68 days)

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

The Insure Pro Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request. The document is an FDA 510(k) clearance letter for the "InSure Pro Test," confirming its substantial equivalence to a predicate device for the detection of early pregnancy.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
  6. Details about standalone algorithm performance.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary. To answer your questions, you would need to refer to the actual 510(k) submission document (K992695) itself, which would contain the performance data and study details.

§ 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.