(108 days)
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No
The description focuses on a standard immunoassay kit and analyzer, with no mention of AI or ML in the intended use, device description, or specific search terms.
No
The device is a test kit for quantitative assays of von Willebrand Factor antigen, which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method," which are tests performed to diagnose or monitor medical conditions.
No
The device description clearly outlines a test kit containing physical reagents (vials of buffer, microlatex particles, diluent solution) which are hardware components. The device is a test kit used with an analyzer, not the analyzer itself, and it is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for performing quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma. Plasma is a biological sample taken from the human body.
- Method: The method described is an immuno-turbidimetric method, which is a common technique used in laboratory testing of biological samples.
- Device Description: The description details reagents used to react with the plasma sample.
- Predicate Device: The predicate device listed (ASSERA®-PLATE vWF kit) is also an IVD, indicating the regulatory pathway for this type of test.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The STA® -Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of fight absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Each STA®-Liatest vWF test kit provides: 4 x 5-ml vials of ready-for-use glycine buffer; 4 x 2-ml vials of a suspension of microlatex particles coated with rabbit antihuman vWF antibodies; 4 x 4-ml vials of diluent solution containing glycine for dilution of the latex reagent before use.
Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials or after dilution, kit reagents are stable for 15 days 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.
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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§ 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).
0
K96X625
AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA®-Liatest® vWF Test Kit
OCT 2 2 1990
Page 31 of 31
OCT 2 5 1996
VIII. Safety and Effectiveness Summary
The STA® -Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of fight absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.
Each STA®-Liatest vWF test kit provides: 4 x 5-ml vials of ready-for-use glycine buffer; 4 x 2-ml vials of a suspension of microlatex particles coated with rabbit antihuman vWF antibodies; 4 x 4-ml vials of diluent solution containing glycine for dilution of the latex reagent before use.
Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials or after dilution, kit reagents are stable for 15 days on board the STA® analyzer.
The proposed STA®-Liatest® vWF test kit has demonstrated substantial equivalence to the commercially available ASSERA®-PLATE vWF kit (Diagnostica Stago, France; K861417) which is an electro-immunodiffusion procedure for the quantitative determination of vWF antigen levels in citrated plasma.