(43 days)
There are no K/DEN numbers present in the document.
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No
The summary describes a calibrator for a bilirubin assay, which is a chemical standard, not a software or imaging device. There are no mentions of AI, ML, or related concepts.
No.
The device is a calibrator used to establish calibration points for the determination of bilirubin values, not to treat any condition.
No
The device is a calibrator, used to establish calibration points for the determination of bilirubin values, not to diagnose a condition itself.
No
The device description explicitly states it is a "Wako Bilirubin Calibrator," which is a physical substance used to calibrate laboratory equipment, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "to establish calibration points for the determination of Total and Direct bilirubin values in human serum specimens." This involves testing human specimens in vitro (outside the body) to obtain diagnostic information (bilirubin levels).
- Device Description: The description reinforces this by stating it's used with "Wako's total and direct bilirubin methodology for the determination of total and direct bilirubin in serum." Again, this points to in vitro testing of human serum.
- Function: The device is a calibrator. Calibrators are essential components of many in vitro diagnostic tests, used to ensure the accuracy of the measurements.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to perform tests on human biological samples for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The Wako Bilirubin Calibrator is intended to be used with Wako's total and direct bilirubin methodology for the determination of total and direct bilirubin in serum.
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Product codes
JIS
Device Description
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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)
The safety and effectiveness of the Wako Bilirubin Calibrator is demonstrated by its substantial equivalency to the Wako Bilirubin Standard. Both calibration material are intended for the determination of bilirubin in serum. In comparison studies against the predicate bilirubin standard, a correlation coefficient of 1.000 and a regression equation of y =0.99x -.0027 was obtained for total bilirubin and a correlation coefficient of 0.9999 and a regression equation of y=0.97x -0.0031 for direct bilrubin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 date November 9, 1999. The month is abbreviated to NOV. The day is the number 9. The year is 1999.
Image /page/0/Picture/1 description: The image shows the word "Wako" in bold, white letters against a black background. The text is simple and clear, with a modern sans-serif font. The word is positioned in the upper-left corner of the black square.
Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.