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K Number
K052694
Device Name
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2005-12-16

(79 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

One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a medical device called "One Step HCG Pregnancy Test 2000 mIU / mL." This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information needed to answer the specific questions about acceptance criteria and device performance as typically found in a clinical study report.

Therefore, I cannot provide a comprehensive answer to your request based on the given input. The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies.
  6. Details on standalone algorithm performance.
  7. Type of ground truth used (beyond implying a "determination of human chorionic gonadotropin (HCG) concentration").
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document states the device is a "qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL to aid in the detection of pregnancy." This implies that the device's performance would be evaluated based on its accuracy (sensitivity and specificity) in detecting HCG at or above the 2000 mIU/mL threshold against a known reference method or clinical outcome, but the specific study details are not present.

§ 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.