(40 days)
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No
The summary describes a blood collection tube, a passive device, and makes no mention of AI or ML.
No
The device is a blood collection tube used for diagnostic evaluation of whole blood specimens, not for treating a disease or condition.
No
This device is a blood collection tube, which is a tool used to collect and prepare blood specimens for evaluation, but it does not perform any diagnostic function itself. The diagnostic function would be performed by lab equipment analyzing the collected blood.
No
The device description clearly states it is a physical blood collection tube made of plastic, containing an anticoagulant additive. It is a hardware device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "intended for use in evaluations of whole blood specimens." This indicates the device is used to collect and prepare biological specimens for diagnostic testing.
- Device Description: It's a "blood collection device containing EDTA K2 anticoagulant additive." This additive is crucial for preserving the blood specimen for subsequent in vitro diagnostic tests (specifically hematology parameters, as mentioned later).
- Performance Studies: The performance studies evaluate the "equivalency of assay results" when using this tube compared to a predicate device. This directly relates to the performance of the device in preparing samples for diagnostic assays.
- Key Metrics: The mention of "good correlation was observed for 15 hematology parameters" further reinforces its role in facilitating accurate diagnostic testing.
- Predicate Device: The identification of a predicate device (Becton Dickinson's Vacutainer® brand EDTA K additive tube) which is also a blood collection tube used for in vitro diagnostics, supports the classification of this device as an IVD.
In summary, the device is designed to collect and prepare a biological specimen (whole blood) for subsequent in vitro diagnostic testing (evaluations of hematology parameters). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive and intended for use in evaluations of whole blood specimens.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 15 hematology parameters were evaluated and good correlation was observed.
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.
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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
MAY 12 1997
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 EDTA K2. The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive and intended for use in evaluations of whole blood specimens.
Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand EDTA K additive tube. Both blood collection tubes have the same intended use and contain the same stopper material and additive. The tube material for the Greiner product is clear plastic, and the material for the Becton Dickinson product is glass. The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 15 hematology parameters were evaluated and good correlation was observed.
Greiner's 510(k) has been submitted on April 1, 1997, by Ed Maier, Managing Director, Greiner America, Inc., P.O. Box 953279, Lake Mary, Florida 32795/3279 (407/3332800).