(182 days)
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No
The 510(k) summary describes a standard blood collection tube and its performance in comparison to a predicate device. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
The device is a blood collection tube used for holding and separating blood components for diagnostic purposes, not for treating a disease or condition.
No
The device is a blood collection tube intended for holding and separating blood plasma, not for diagnosing a medical condition. It is a sample collection device, not a diagnostic one.
No
The device description clearly indicates it is a physical blood collection tube containing chemical additives and a barrier material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "holding and separating blood plasma from the cellular components of blood." This is a crucial step in preparing blood samples for various laboratory tests, which are performed in vitro (outside the body).
- Device Description: The description details a "blood collection device" containing additives used for processing blood samples for testing.
- Performance Studies: The summary of performance studies describes evaluating the equivalency of assay results using samples collected in these tubes. Assays are laboratory tests performed in vitro.
- Predicate Device: The predicate device is another blood collection tube used for similar purposes, which are inherently linked to in vitro diagnostic testing.
While the document doesn't explicitly use the term "IVD" in the intended use, the function and context of the device clearly place it within the realm of in vitro diagnostics. It is a tool used to prepare biological samples for subsequent diagnostic testing performed in a laboratory setting.
N/A
Intended Use / Indications for Use
The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Greiner Vacuette" blood collection tube with anticoagulant lithium heparin and gel separator. The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material.
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 equivalency of assay results was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 23 analytes and 3 hormones were evaluated. Good correlation was observed, with correlation coefficients ranging from 0.868 to 0.900.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Good correlation was observed, with correlation coefficients ranging from 0.868 to 0.900.
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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§ 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.
0
AUG 30 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS I.
Greiner America, Inc. ("Greiner") is submitting. a
510(k) premarket notification for its Greiner Vacuette" blood collection tube with anticoagulant lithium heparin and gel separator. The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand lithium heparin additive tube Both blood collection tubes have the same intended (K944566). use and contain the same stopper material, additive and The tube material for the Greiner product is clear separator. plastic, whereas the material for the Becton Dickinson product is glass. The equivalency of assay results was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 23 analytes and 3 hormones were evaluated. Good correlation was observed, with correlation coefficients ranging from 168 to 0.900.
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).
01/239242.1