DIMENSION C4 FLEX REAGENT CARTRIDGE

• K Number: K994293
• Device Name: DIMENSION C4 FLEX REAGENT CARTRIDGE
• Manufacturer: DADE BEHRING, INC.
• Date Cleared: 2000-03-01 ( 71 days)
• Product Code: DBI
• Regulation Number: 866.5240
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: K780913 , K922273

Intended Use

The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

Device Description

The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Correlation	0.980
Slope	1.01
Intercept	6.7 mg/dL

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 94 clinical patient samples.
   • Data Provenance: Not explicitly stated, but the reference to "clinical patient samples" typically implies data from a clinical setting, often prospective or collected retrospectively for validation. The country of origin is not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This information is not provided in the document. The study compares the new device to a predicate device, and the "ground truth" essentially comes from the established method of the predicate device.

3. Adjudication Method for the Test Set:

   • Not applicable. This was a direct comparison study (split sample comparison) between two methods of measuring C4, not an interpretive one requiring adjudication of expert opinions.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This was a technical performance comparison between two in vitro diagnostic devices, not a study involving human readers interpreting results or making clinical decisions.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, this was a standalone performance study of the C4 Flex® Reagent Cartridge. Its performance was compared against the Beckman Array® Complement C4 Assay.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the results obtained from the predicate device, the Beckman Array® Complement C4 Assay. This method is assumed to be an established and accepted method for measuring C4.

7. The Sample Size for the Training Set:

   • Not specified. The document describes a validation study comparing the new device to a predicate, not the development or training of the new device itself.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as a training set and its ground truth establishment are not discussed in this document, which focuses on the validation of the device against a predicate.

Regulation Number and Section

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).