(44 days)
IMx® Free T4 Calibrator
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No
The summary describes a calibrator for an immunoassay system, which is a chemical reagent used for calibration, and there is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a calibrator for an immunoassay system, used to ensure the accuracy of Free Thyroxine (FT4) measurements, not to treat a condition or provide therapy.
No
The device is a calibrator for an immunoassay system, used to calibrate the Free Thyroxine (FT4) Method. Calibrators are used to ensure the accuracy of a diagnostic test, but they are not diagnostic devices themselves; they are reagents used in diagnostic testing.
No
The device description clearly states it is a "lyophilized human serum-based product," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibrating the Free Thyroxine (FT4) Method" on an "immunoassay system." Immunoassays are laboratory tests performed in vitro (outside the body) to measure substances in biological samples.
- Device Description: The description mentions it's a "lyophilized human serum-based product." Serum is a biological sample.
- Function: Calibrators are essential components of many in vitro diagnostic tests. They are used to establish a standard curve or reference point for accurate measurement of the analyte (in this case, FT4) in patient samples.
Therefore, based on its intended use and description, this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IMx® Free T4 Calibrator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the word "DADE" in bold, black, sans-serif font. The letters are large and fill the frame. The background is white, providing a strong contrast to the black letters.
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. Craft
Dade International Inc.
P.O. Box 6101
Newark, 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