(73 days)
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No
The summary describes a blood collection tube and its performance characteristics related to physical properties and clinical equivalence for standard chemistry assays. There is no mention of AI or ML.
No.
The device is used for collecting, transporting, separating, and processing blood for diagnostic chemistry assays, not for treating a disease or condition.
No.
The device is described as an evacuated tube for collecting, transporting, separating, and processing venous blood for clinical laboratory chemistry assays. It is a tool for specimen collection and preparation, not for making a diagnosis itself.
No
The device is a physical evacuated tube for collecting and processing blood, not a software application.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected blood is "primarily used for clinical laboratory chemistry assays using patient serum." Clinical laboratory assays are a core function of in vitro diagnostics.
- Device Description: The device is a blood collection tube designed for processing blood for these assays.
- Intended User / Care Setting: The intended user is a "clinical laboratory," which is the typical setting for performing IVD tests.
While the device itself doesn't perform the diagnostic test, it is an essential component in the process of collecting and preparing the sample for an in vitro diagnostic test. Therefore, it falls under the umbrella of IVD devices.
N/A
Intended Use / Indications for Use
An evacuated tube which provides a means of collecting, transporting, separating and processing venous blood in a closed system. Blood collected in these tubes is primarily used for clinical laboratory chemistry assays using patient serum but may be used for other serum specimens as determined by the laboratory.
Product codes
75JKA
Device Description
VACUTAINER® Brand PLUS (plastic) Serum and SST® Serum Separator Tubes ("Full Draw" Tubes Only)
Mentions image processing
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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
clinical laboratory
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
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Summary of Performance Studies
- Breakage reduction is demonstrated in a study consisting of drop testing and centrifugation testing.
- Waste disposal improvement is demonstrated in a study of the by products of incineration for the components separately and the product as a whole.
- Reduced blood exposure is demonstrated in a study comparing VACUTAINER® Brand Tubes with the HEMOGARD™ closure to both VACUTAINER® Brand Tubes with the conventional rubber stopper and competitive tubes.
- Equivalent clinical performance to the current VACUTAINER® Brand Tubes was demonstrated in a study which compared the current VACUTAINER® Brand PLUS SST® Serum Separator Tube to the proposed VACUTAINER® Brand PLUS SST® Serum Separator Tube for the following analytes: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (initial time only), blood urea nitrogen (BUN), calcium, chloride, cholesterol, creatinine, glucose, gammaglutamyl transferase (GGT), iron, phosphorus, potassium, sodium, protein, triglycerides, and uric acid. A difference in lactate dehydrogenase (LD) levels was noted. The performance characteristics of the gel barrier and the presence of fibrin, red cells and hemolysis were assessed visually. The partial draw evaluation tubes exhibited a film of red blood cells on the tube wall above the barrier; therefore, these tubes will not be Note: All 13 X 100 size tubes used in clinical modified. studies were partial draw tubes. The results demonstrated equivalent functional performance.
- Minimization of the possibility of obtaining elevated levels of vitamin Big and folate obtained when these Tubes are used to collect samples to be tested on the CIBA Corning ACS:180® Analyzer was demonstrated in a study comparing the current glass VACUTAINER® Brand Serum Tube without silicone to the proposed VACUTAINER® Brand SST® Serum Separator Tube. The glass VACUTAINER® Brand Serum Tube was chosen as the control because this tube has no coatings. The study was performed in collaboration with CIBA Corning Diagnostics. NOTE: This report is proprietary and confidential and is the property of CIBA Corning Diagnostics and Becton Dickinson VACUTAINER Systems. The results demonstrated a minimization of the interference.
Key Metrics
Not Found
Predicate Device(s)
VACUTAINER® Brand PLUS Serum and SST® Serum Separator Tubes (All Tube Volumes)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, New Jersey 07417-1885
(201) 847-4500
| 510(k) SUMMARY | |
|---|---|
| MAR 29 1996 | |
| Submitter: | Denise Duchene |
| Becton Dickinson VACUTAINER Systems | |
| 1 Becton Drive | |
| Franklin Lakes, New Jersey 07417-1885 | |
| 201-847-6280 | |
| Date: | January 9, 1996 |
| Device: | VACUTAINER® Brand PLUS (plastic) Serum and SST® Serum |
| Separator Tubes ("Full Draw" Tubes Only) | |
| Classification | 75JKA - Tubes, Vials, Systems, Serum Separators, Blood |
| Collection | |
| Predicate | |
| Device: | VACUTAINER® Brand PLUS Serum and SST® Serum Separator |
| Tubes (All Tube Volumes) | |
| Intended Use: | An evacuated tube which provides a means of collecting, |
| transporting, separating and processing venous blood in | |
| a closed system. Blood collected in these tubes is | |
| primarily used for clinical laboratory chemistry assays | |
| using patient serum but may be used for other serum | |
| specimens as determined by the laboratory. | |
| Proposed | |
| Modification: | Reduction in the amount of the silicone tube coating. |
Becton Dickinson VACUTAINER Systems has determined that the reduction
in the amount of silicone surfactant in the "full draw" tubes will not
impact the safety or effectiveness of the product for its intended
use. Testing has shown that the clinical performance of the proposed
tubes is equivalent to the current plastic tubes.
No new claims will be made for either the VACUTAINER® Brand PLUS Serum
or PLUS SST® Serum Separator Tubes.
Synopsis of Test Methods and Results
- Breakage reduction is demonstrated in a study consisting of drop
testing and centrifugation testing.
46ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1971 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
1
Waste disposal improvement is demonstrated in a study of the by products of incineration for the components separately and the product as a whole.
Reduced blood exposure is demonstrated in a study comparing VACUTAINER® Brand Tubes with the HEMOGARD™ closure to both VACUTAINER® Brand Tubes with the conventional rubber stopper and competitive tubes.
- Equivalent clinical performance to the current VACUTAINER® Brand Tubes was demonstrated in a study which compared the current VACUTAINER® Brand PLUS SST® Serum Separator Tube to the proposed VACUTAINER® Brand PLUS SST® Serum Separator Tube for the following analytes: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (initial time only), blood urea nitrogen (BUN), calcium, chloride, cholesterol, creatinine, glucose, gammaglutamyl transferase (GGT), iron, phosphorus, potassium, sodium, protein, triglycerides, and uric acid. A difference in lactate dehydrogenase (LD) levels was noted. The performance characteristics of the gel barrier and the presence of fibrin, red cells and hemolysis were assessed visually. The partial draw evaluation tubes exhibited a film of red blood cells on the tube wall above the barrier; therefore, these tubes will not be Note: All 13 X 100 size tubes used in clinical modified. studies were partial draw tubes.
The results demonstrated equivalent functional performance.
Minimization of the possibility of obtaining elevated levels of vitamin Big and folate obtained when these Tubes are used to collect samples to be tested on the CIBA Corning ACS:180® Analyzer was demonstrated in a study comparing the current glass VACUTAINER® Brand Serum Tube without silicone to the proposed VACUTAINER® Brand SST® Serum Separator Tube. The glass VACUTAINER® Brand Serum Tube was chosen as the control because this tube has no coatings. The study was performed in collaboration with CIBA Corning Diagnostics. NOTE: This report is proprietary and confidential and is the property of CIBA Corning Diagnostics and Becton Dickinson VACUTAINER Systems.
The results demonstrated a minimization of the interference.