(14 days)
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No
The document describes a control kit for a laboratory assay and does not mention any AI or ML components.
No
The device is a control kit for in-vitro diagnostic tests, used to assess the accuracy of vWF antigen assays, not to treat a condition.
No
This device is described as a control kit for an antigen assay, intended to provide normal and abnormal control plasmas for testing, rather than to make a diagnosis itself. The diagnostic function is performed by the "STA® analyzer."
No
The device description clearly states it is a kit containing freeze-dried human plasma, which 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 that the kit provides controls for "von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer." This indicates the device is used in vitro (outside the body) to analyze a sample (human plasma) for a specific analyte (vWF).
- Device Description: The description details the composition of the kit (citrated human plasmas) and how it is used in conjunction with an analyzer (STA® analyzer) to perform a diagnostic test.
- Nature of the Test: The test is an "immuno-turbidimetric method," which is a common technique used in clinical laboratories for in vitro diagnostic testing.
The device is a control material used to ensure the accuracy and reliability of an in vitro diagnostic test (the vWF antigen assay). Control materials are considered IVDs themselves as they are essential components of the diagnostic process.
N/A
Intended Use / Indications for Use
The STA® vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays 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 STA®-VWF Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 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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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA®-vWF Control [N]+[P] Kit
VII. SAFETY AND EFFECTIVENESS SUMMARY
The STA® vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).
Each manufactured lot of STA®-vWF Control [N]+[P] is assigned vWF values (normal and abnormal levels) which are determined with an internal WF 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 Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board the STA® analyzer.