(182 days)
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No
The 510(k) summary describes a blood collection tube, a passive device for sample collection and separation, with no mention of AI or ML capabilities.
No
Explanation: The device is intended for blood collection and separation for diagnostic purposes, not for treating or therapeutically intervening in a disease or condition.
No
The device is an evacuated blood collection tube intended for holding and separating blood serum from cellular components, which is a preparatory step for diagnostic testing, but not a diagnostic device itself.
No
The device description clearly states it is an "evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "holding and separating blood serum from the cellular components of blood." This is a crucial step in preparing a blood sample for subsequent in vitro diagnostic testing.
- Device Description: The description details the components that facilitate this process (clot activator and gel separator), which are designed to prepare the sample for analysis outside of the body.
- Performance Studies: The performance studies compare the results obtained using this tube with a predicate device (Becton Dickinson's Vacutainer® SST tubes) for various analytes. This demonstrates that the device is intended to be used in conjunction with diagnostic tests to obtain results.
- Predicate Device: The predicate device listed (Becton Dickinson's Vacutainer® SST tubes) is also a well-known IVD device used for blood collection and processing for diagnostic testing.
While the document doesn't explicitly state "for in vitro diagnostic use," the intended use and the context of its function within the process of preparing a blood sample for laboratory analysis clearly indicate that it falls under the definition of an In Vitro Diagnostic device. It is a sample collection and preparation device specifically designed to facilitate subsequent diagnostic testing performed outside of the body.
N/A
Intended Use / Indications for Use
The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier The product is intended for use in holding and material. separating blood serum from the cellular components of blood.
Product codes
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Device Description
The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier The product is intended for use in holding and material. separating blood serum from the cellular components of blood. The tube material for the Greiner product is clear plastic.
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
The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 41 analytes were evaluated demonstrating good correlation (correlation coefficients ranging from .864 to 1.000).
Key Metrics
correlation coefficients ranging from .864 to 1.000
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K960858'. The characters are written in a cursive style, with thick, dark strokes, giving them a bold appearance against the white background. The handwriting is somewhat stylized, with rounded shapes and connected letters, making it look like a signature or a unique identifier.
AUG 30 1996
I. 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for its Greiner Vacuette™ blood collection tube with clot activator and gel separator. The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier The product is intended for use in holding and material. separating blood serum from the cellular components of blood.
Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® SST tubes (K921806). Both blood collection tubes have the same intended use and contain the same stopper material, clot activator and separator. The tube material for the Greiner product is clear plastic, whereas the material for the Becton Dickinson product is glass. The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 41 analytes were evaluated demonstrating good correlation (correlation coefficients ranging from .864 to 1.000) .
Greiner's 510(k) has been submitted on February 27, 1996, by Ed Maier, Managing Director, Greiner America, Inc., 7 Henry Court, Wilmington, Delaware, 19808 (302/998-8046).