(40 days)
Not Found
Not Found
No
The device description and performance studies focus on the chemical composition and function of blood collection tubes, with no mention of AI or ML technologies.
No
The device is described as an evacuated blood collection device intended for use in testing glucose and lactate levels in blood, indicating a diagnostic rather than therapeutic purpose.
No
Explanation: The device is a blood collection tube used for testing glucose and lactate levels in blood, but it does not perform the diagnostic analysis itself. It is a tool for sample collection, which is part of the diagnostic process, but not a diagnostic device on its own.
No
The device description clearly states it is a blood collection tube, which is a physical hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for use in testing glucose and lactate levels in blood." This clearly indicates the device is used to examine specimens derived from the human body (blood) to provide information for diagnostic purposes (testing glucose and lactate levels).
- Device Description: The description details "evacuated blood collection devices" which are used to collect blood samples for testing. This is a common type of device used in in vitro diagnostic procedures.
- Performance Studies: The summary of performance studies describes evaluating "assay results" from blood samples collected in these tubes. Assays are laboratory tests performed on biological samples, which is a core component of in vitro diagnostics.
- Predicate Devices: The predicate devices listed are also blood collection tubes used for similar testing, further reinforcing the IVD nature of the device.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures. This device fits this definition.
N/A
Intended Use / Indications for Use
Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
(1) its Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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® EDTA/sodium flouride tubes and Becton Dickinson Vacutainer® sodium EDTA and sodium fluoride tubes, and paired samples collected in Greiner Vacuette® potassium oxalate and sodium fluoride tubes and Becton Dickinson potassium oxalate and sodium fluoride tubes. Glucose assay results from paired samples for each tube type were evaluated and good correlation was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Becton Dickinson's Vacutainer® tube with sodium EDTA/sodium fluoride, Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate
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.
Not Found
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).
Not Found
§ 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
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 1 2 1997
ts Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for: (1) its Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
For the above two tubes. Greiner is claiming substantial equivalence to, respectively: (1) Becton Dickinson's Vacutainer® tube with sodium EDTA/sodium fluoride; and (2) Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate. Both the Greiner and Becton Dickinson blood collection tubes have the same intended use and contain the same stopper material and additives. 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® EDTA/sodium flouride tubes and Becton Dickinson Vacutainer® sodium EDTA and sodium fluoride tubes, and paired samples collected in Greiner Vacuette® potassium oxalate and sodium fluoride tubes and Becton Dickinson potassium oxalate and sodium fluoride tubes. Glucose assay results from paired samples for each tube type 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).