(44 days)
The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.
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.
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.
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AUG 1 5 1996
DADE INTERNATIONAL
Interoffice Memorandum
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Cathy P. CraftDade International Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | 6/28/96 |
| Name of Product: | aca® plus FT4 Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Abbott Laboratories*IMx® Free T4 Calibrator |
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.
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.
Comparison to Predicate Device:
| Item | aca® plus FT4 Calibrator | IMx® Free T4 Calibrator |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | thyroxine | thyroxine |
| Matrix | human serum base | human serum base |
| Form | lyophilized | liquid |
| Volume | 3.0 mL per vial, reconstituted | 4.0 mL per vial |
| Levels | 3 levels | 6 levels |
- IMx® is a trademark of Abbott Laboratories, Abbott Park, II 60064
§ 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.