(66 days)
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No
The device description and intended use focus on a calibration plasma for a specific assay method on a known analyzer, with no mention of AI or ML technologies.
No
The device is a calibrator for an in-vitro diagnostic test, not a device used to treat or intended to treat a disease.
No
This device is described as a calibrator for an assay, not the assay or device itself that performs the diagnostic measurement. It helps ensure the accuracy of a diagnostic test for von Willebrand Factor.
No
The device is a physical reagent (citrated human plasma) in freeze-dried form, not a software-only device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer". This describes a product used in vitro (outside the body) to calibrate a diagnostic test.
- Device Description: The description details a "citrated human plasma" used as a reagent in a laboratory setting.
- Context: The device is used with the STA® analyzer (K942117), which is a diagnostic instrument.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level, intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Each manufactured lot of STA®-VWF Calibrator is assigned a vWF value which is determined with an internal VWF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor established in 1992.
Each STA®-vWF Calibrator kit provides 6 x 1-ml vials of citrated human plasma in freeze-dried form. The vWF value of each lot is provided in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board the STA® analyzer.
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.
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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.
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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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA®-vWF Calibrator Kit
VII. SAFETY AND EFFECTIVENESS SUMMARY
The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level, intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).
Each manufactured lot of STA®-VWF Calibrator is assigned a vWF value which is determined with an internal VWF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor established in 1992.
Each STA®-vWF Calibrator kit provides 6 x 1-ml vials of citrated human plasma in freeze-dried form. The vWF value of each lot is provided in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board the STA® analyzer.