K Number
K060371
Manufacturer
Date Cleared
2006-03-09

(24 days)

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

The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.

Device Description

The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay. The calibrators contain tacrolimus in preserved whole blood hemolysate. The calibrator kit consists of one vial of each calibrator level with target concentrations of 0, 2.5, 5, 10, 20, and 30 ng/mL of tacrolimus.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Emit® 2000 Tacrolimus Calibrators, focusing on establishing substantial equivalence to a predicate device. It describes the device, its intended use, and comparison to the predicate, but does not provide details of performance studies with specific acceptance criteria.

Therefore, I cannot populate the requested table and information.

§ 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.