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K Number
K990554
Device Name
DIMENSION SPECIAL PROTEIN CALIBRATOR
Manufacturer
DADE BEHRING, INC.
Date Cleared
1999-03-22

(28 days)

Product Code
JIT
Regulation Number
862.1150
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Dimension® Special Protein Calibrator is intended to be used to calibrate the Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system.
The Special Protein Calibrator for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended for use in an in vitro test system to establish points of reference that are used in determination of values in the measurement of human substances.

Device Description

The Dimension® Special Protein Calibrator is a liquid human serum-based product. The kit consists of ten vials; two at each of five levels.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Dimension® Special Protein Calibrator). It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the document does not contain the information requested to fill out the table regarding acceptance criteria and a study proving the device meets those criteria.

Specifically:

  • No acceptance criteria are mentioned. The document is focused on comparing the new calibrator to a predicate calibrator.
  • No specific study results (performance, accuracy, precision, etc.) are reported for the Dimension® Special Protein Calibrator itself. The comparison is limited to intended use, analytes, matrix, form, volume, levels, and reference.
  • There is no discussion of sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These are all elements typically found in a study designed to demonstrate performance against set acceptance criteria, which is not what this 510(k) summary provides.

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.