(30 days)
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No
The 510(k) summary describes a standard blood collection tube and does not mention any AI or ML components or functionalities.
No
This device is an evacuated blood collection tube used for coagulation analyses, meaning it's a diagnostic tool, not a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a blood collection tube used for evaluations of coagulation analyses, meaning it's a sample collection device, not a device that performs the diagnostic analysis itself. It's an accessory to a diagnostic process.
No
The device description clearly states it is an "evacuated blood collection device containing sodium citrate anticoagulant additive," which is a physical hardware component (a tube).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "evaluations of coagulation analyses." This means the device is used to test a sample (blood) outside of the body to gain information about a patient's health status (their coagulation).
- Device Description: It's a "blood collection device containing sodium citrate anticoagulant additive." This describes a product designed to collect and prepare a biological sample for in vitro testing.
- Performance Studies: The performance studies describe testing "paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes" and evaluating "coagulation parameters." This further confirms its use in laboratory testing of biological samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This description perfectly aligns with the information provided for the Greiner Vacuette® blood collection tube with sodium citrate.
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Intended Use / Indications for Use
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate 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
Test results from paired samples for 2 coagulation parameters were evaluated and good correlation was observed.
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.
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.
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MAY - 2 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 sodium citrate . The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® sodium citrate 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 2 coagulation 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 (407/333-2800).
WA01A/81001.1