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K Number
K992199
Device Name
ACID HEMOGLOBIN KIT
Manufacturer
HELENA LABORATORIES
Date Cleared
1999-09-21

(83 days)

Product Code
JBD
Regulation Number
864.7440
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis.

The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Acid Hemoglobin Kit." This document does not contain any information about the acceptance criteria, device performance, sample sizes, expert qualifications, or study details that you have requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given text.

§ 864.7440 Electrophoretic hemoglobin analysis system.

(a)
Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.(b)
Classification. Class II (performance standards).