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K Number
K020710
Device Name
BIOTEST HEMOGLOBIN MEASURING SYSTEM
Manufacturer
BIOTEST MEDIZINTECHNIK GMBH
Date Cleared
2002-08-14

(162 days)

Product Code
GKR
Regulation Number
864.5620
Type
Abbreviated
Panel
Hematology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.

Device Description

Not Found

AI/ML Overview

I am sorry, but there is no information about acceptance criteria or a study that proves the device meets the acceptance criteria in the provided text. The document is an FDA 510(k) substantial equivalence letter for the Bio.Track LLC Biotest Hemoglobin Measuring System, which primarily confirms that the device can be marketed. It does not contain details regarding performance studies, sample sizes, ground truth establishment, or expert qualifications.

§ 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).