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K Number
K122304
Device Name
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-04-15

(257 days)

Product Code
DBA
Regulation Number
866.5250
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for an in vitro diagnostic device, the "Human C1 Inactivator Kit for use on SPAPLUS." It does not contain any information about the acceptance criteria or study details for proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which is a separate document).

The letter primarily confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulation name, regulatory class, and product codes. It also outlines responsibilities of the manufacturer regarding general controls, labeling, and reporting.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test or training sets, nor data provenance.
  • Details about experts for ground truth establishment or adjudication methods.
  • Information on MRMC studies or standalone algorithm performance.
  • The type or establishment method of ground truth.

§ 866.5250 Complement C

1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).