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K Number
K052148
Device Name
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
Manufacturer
REFERENCE DIAGNOSTICS, INC.
Date Cleared
2005-11-09

(93 days)

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

The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves whether the Direct TIBC Calibrator Set meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance study details, acceptance criteria, or performance data.

§ 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.