(188 days)
None
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No
The summary describes a blood collection tube, which is a passive device and does not mention any computational or analytical capabilities that would involve AI/ML.
No.
The device is described as a blood collection tube intended for evaluations of whole blood specimens, which is a diagnostic purpose, not a therapeutic one.
No
This device is a blood collection tube used to collect and preserve whole blood specimens for evaluation. It does not perform any diagnostic analysis itself, but rather provides the sample that would be used for diagnostic testing. Its purpose is to facilitate the diagnostic process by collecting the specimen, not to diagnose.
No
The device description clearly states it is an "evacuated blood collection device containing EDTA K, anticoagulant additive" and is made of "clear plastic," indicating it is a physical hardware device (a blood collection 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 whole blood specimens." This means the device is used to collect and prepare a biological sample (blood) for subsequent testing or analysis outside of the body (in vitro).
- Device Description: It's a "blood collection device containing EDTA K, anticoagulant additive." This further confirms its role in preparing a sample for laboratory testing.
- Performance Studies: The performance studies describe evaluating "assay results" and "hematology parameters," which are typical activities performed in a clinical laboratory setting using IVD devices.
- Predicate Device: The predicate device is another blood collection tube with an anticoagulant, which is a common type of IVD used in hematology testing.
While the document doesn't mention image processing, AI, or specific performance metrics like sensitivity or specificity (which are more relevant for diagnostic tests that interpret results), the core function of collecting and preparing a biological sample for in vitro evaluation clearly places it within the definition of an IVD.
N/A
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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
5 1998 SEP
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 EDTA K3. The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, 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 (K940905).
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 February 27, 1996, by Ed Maier, Managing Director, Greiner America, Inc., 7 Henry Court, Wilmington, Delaware, 19808 (302/998-8046).
101/239174.1