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K Number
K062096
Device Name
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
Manufacturer
KOREAMEDICO CO. LTD.
Date Cleared
2007-05-07

(287 days)

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

The Chextic is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary from the FDA for a pregnancy test, not a study describing the acceptance criteria and performance of a device with AI components. Therefore, the document does not contain the information requested in the prompt regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study with AI.
  6. Standalone algorithm performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. Method for establishing ground truth for the training set.

The document is a regulatory approval letter for a traditional in-vitro diagnostic device (a urine pregnancy test), and thus does not involve AI, statistical studies for AI performance, or detailed clinical trial information in the format requested.

§ 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.