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K Number
K990998
Device Name
POLYSLIT IFE KIT
Manufacturer
HELENA LABORATORIES
Date Cleared
1999-06-28

(95 days)

Product Code
CFF
Regulation Number
866.5510
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This kit is intended for the separation of immunoglobulins using agarose gel electrophoresis. This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such which cypically Chilbre annual collagen disorders and other chronic infections.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter from the FDA for a device called "Polyslit IFE Kit," and it doesn't contain information about acceptance criteria or a study proving that a device meets those criteria, as it's not a performance evaluation report. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).