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K Number
K031445
Device Name
MAINLINE MAXIE HCG URINE PREGNANCY TEST
Manufacturer
MAINLINE TECHNOLOGY, INC.
Date Cleared
2003-07-01

(55 days)

Product Code
JHI
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

The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.

Device Description

Not Found

AI/ML Overview

The provided document does not contain enough information to complete the requested table and answer the questions regarding acceptance criteria and study details.

This document is a 510(k) clearance letter from the FDA for a device called "Maxie hCG Urine." It confirms that the device has been found substantially equivalent to a legally marketed predicate device. While it states the "Indications For Use" and the "cut off concentration of 20 mIU/ml" for early detection of pregnancy, it does not include:

  • Specific acceptance criteria: The document doesn't outline a table of performance metrics (e.g., sensitivity, specificity, accuracy) that the device needed to meet.
  • Study details: There is no mention of the study conducted to demonstrate the device's performance, including:
    • Reported device performance values.
    • Sample size (test or training set).
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC or standalone study details.
    • Type of ground truth used.
    • Training set information.

To provide the requested information, a separate study report or detailed submission document to the FDA would be necessary.

§ 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.