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K Number
K962594
Device Name
ACA PLUS FT4 CALIBRATOR
Manufacturer
DADE INTL., INC.
Date Cleared
1996-08-15

(44 days)

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

The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.

Device Description

The FT4 Calibrator is a lyophilized human serum-based product. The Level 1 calibrator contains no detectable thyroxine. The kit consists of six vials two at each of three levels.

AI/ML Overview

The provided document is a summary of safety and effectiveness information for a medical device called "aca® plus FT4 Calibrator". This document does not describe an AI device or a study involving an AI algorithm evaluating performance against acceptance criteria.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable to the content of this document. This document pertains to a laboratory calibrator and its comparison to a predicate device, not an AI efficacy study.

§ 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.