(15 days)
aca® plus FT4 Calibrator, aca® plus TSH Calibrator
None
No
The summary describes a chemical calibrator for a clinical chemistry system and makes no mention of AI or ML.
No
Explanation: The device is a calibrator used for in vitro diagnostic (IVD) methods to ensure the accuracy of other measurements, not to treat or diagnose a disease in a patient.
No
The device is a calibrator used with an immunoassay system to maintain accuracy, not to diagnose a condition itself.
No
The device description clearly states it is a liquid bovine albumin 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 methods (FT4 and TSH) on a clinical chemistry system. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: The description details a product used in a laboratory setting (liquid, bovine albumin based, containing analytes like thyroxine and TSH) that is applied to a clinical chemistry system.
- Predicate Devices: The mention of predicate devices (aca® plus FT4 Calibrator and aca® plus TSH Calibrator) which are also calibrators for in vitro diagnostic tests further supports its classification as an IVD.
Calibrators are considered IVDs because they are used in vitro (outside the body) to establish the relationship between the signal measured by an analytical instrument and the concentration of an analyte in a biological sample. This is a fundamental part of the process of performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.
Product codes
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Device Description
The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
aca® plus FT4 Calibrator, aca® plus TSH Calibrator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "DADE" in large, bold, black letters. The letters are sans-serif and evenly spaced. The word is presented in a straightforward, unadorned manner, with a clear and legible typeface.
Image /page/0/Picture/1 description: The image shows a sequence of numbers, specifically 'K970389'. The numbers are written in a bold, handwritten style, with thick strokes. Below the numbers, there is a dark, rectangular block that obscures any underlying content.
FEB 1 8 1997
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: | 1/29/97 |
| Name of Product: | Thyroid Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | aca® plus FT4 Calibrator and aca® plus
TSH Calibrator |
Device Description: The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.
Intended use: The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.
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Comparison to Predicate Device:
| Item | Thyroid Calibrator | aca® plus
FT4 Calibrator | aca® plus
TSH Calibrator |
|--------------|--------------------|-----------------------------------|-----------------------------------|
| Intended Use | Calibrator | Calibrator | Calibrator |
| Analytes | thyroxine, TSH | thyroxine | TSH |
| Matrix | bovine albumin | human serum | horse serum |
| Form | liquid | lyophilized | lyophilized |
| Volume | 2.0 mL per vial | 3.0 mL per vial,
reconstituted | 5.0 mL per vial,
reconstituted |
| Levels | 5 levels | 3 levels | 3 levels |
Comments on Substantial
Equivalence: Both the Thyroid Calibrator and the aca8 plus FT4 Calibrator are intended to be used as callbrators for free thyroxine methods. Both the Thyroid Calibrator and the aca® plus TSH Calibrator are intended to be used as calibrators for thyroid stimulating hormone methods.
Conclusion: The Thyroid Calibrator is substantially equivalent to the aca® plus FT4 Calibrator and the acad plus TSH Calibrator for their respective analytes based on the comparison discussed above.
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Cathy P. Craft Regulatory Affairs and Compliance Manager Date: 1/29/97
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