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K Number
K031898
Device Name
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
Manufacturer
EKF DIAGNOSTIC GMBH
Date Cleared
2003-09-24

(97 days)

Product Code
GKR,KHG
Regulation Number
864.5620
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hemo Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3011-050 are indicated for use in the Hemo Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only Caution: Federal law restricts this device to sale by or on the order of a physician.

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 in the format you requested.

The document is an FDA 510(k) clearance letter for the EKF-diagnostic Hemo Control Hemoglobin Measurement System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test or training sets.
  • Information on data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness study results or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for the training set was established.

This kind of detailed study information is typically found in the 510(k) submission itself or in scientific publications, not in the FDA's clearance letter.

§ 864.5620 Automated hemoglobin system.

(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).