BD Vacutainer® Serum Separator (SST) Blood Collection Tubes
Device Facts
| Record ID | K230855 |
|---|---|
| Device Name | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes |
| Applicant | Becton, Dickinson and Company |
| Product Code | JKA · Clinical Chemistry |
| Decision Date | Dec 20, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
Indications for Use
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is used for clinical laboratory testing in chemistry and for the monitoring of certain therapeutic drugs.
Device Story
Sterile, single-use, evacuated plastic (PET) blood collection tube; contains inert gel separator and silica clot activator spray-coated with silicone surfactant. Used by trained healthcare professionals in clinical settings to collect venous blood. Controlled vacuum draws blood; inversion mixes additives; centrifugation (1,100-1,300 RCF) causes gel to form mechanical barrier at serum-clot interface. Separated serum is used for clinical chemistry and therapeutic drug monitoring. Potential for hydrophobic drug adsorption to gel requires user caution regarding contact time and storage. Benefits include standardized serum separation and containment for diagnostic testing.
Clinical Evidence
Clinical studies evaluated clinical equivalence, within-tube stability, repeatability, reproducibility, and shelf-life performance. Testing compared subject device against a legally marketed comparator using routine/special chemistry analytes, therapeutic drugs, and cardiac markers. Studies utilized duplicate testing, lot-to-lot, and tube-to-tube reproducibility across multiple instrument platforms. Results met predetermined acceptance criteria, confirming clinical equivalence for chemistry and therapeutic drug monitoring.
Technological Characteristics
PET plastic evacuated tube; silica clot activator; inert polymer separator gel; BD Hemogard™ cap or conventional rubber stopper. Sterilization via Gamma Irradiation (SAL 10^-3 or 10^-6). Dimensions: 13x75mm, 13x100mm, 16x100mm, 16x125mm. Draw volumes: 3.5mL to 10mL. Standards: ASTM D4169-16, ISO 11137 series, ISO 11737 series, ISO 14971.
Indications for Use
Indicated for venous blood collection, containment, transport, and centrifugation to obtain serum for in vitro diagnostic testing and therapeutic drug monitoring in clinical laboratory settings. Contraindicated for trace element testing.
Regulatory Classification
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.
Predicate Devices
- BD Vacutainer® PLUS SST™ Tube (K023075)
Related Devices
- K093910 — IMPROVACUTER GEL & CLOT ACTIVATOR TUBE · Guangzhou Improve Medical Instruments Co., Ltd. · Jul 12, 2010
- K060364 — VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE · Teco Diagnostics · Jun 15, 2006
- K023331 — BD VACUTAINER SST II PLUS TUBES · Becton, Dickinson & CO · Nov 25, 2002
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K230855
B Applicant
Becton Dickinson and Company
C Proprietary and Established Names
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JKA | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification of existing device
B Measurand:
Not applicable. Blood collection tube.
C Type of Test:
Not applicable.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is used for clinical laboratory testing in chemistry and for the monitoring of certain therapeutic drugs.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
Do not use BD Vacutainer® SST™ Tubes for trace element testing.
Do not use if foreign matter is present or if tube is damaged.
Examine tubes prior to use. Clot activator additive is visible in the tube and should appear as white dots. Do not use the tube if the additive is missing, discolored, or if foreign matter or precipitate is present.
Separation of serum from the cells should take place within 2 hours of collection to prevent erroneous test results, unless evidence is available supporting longer times from collection to serum separation.
Follow your facility’s procedures if clots or other visible obstructions are present in the serum sample as this could lead to the inability to test the specimen.
Any change in blood collection tube type, size, handling, processing or storage condition for a particular laboratory assay should be evaluated by the laboratory to verify the current reference range or to establish a new reference range for each instrument/reagent system per the laboratory's standard procedure.
BD Vacutainer® SST™ Blood Collection Tubes may contain trace levels of acetone, hexane, and formate. It has not been determined if the presence of trace levels of these compounds will affect test results in chromatography-based assays.
Hydrophobic drugs have been known to demonstrate gel adsorption in gel separator tubes, which may result in lower measured drug concentrations. However, these effects depend on various factors including the chemical and physical properties of the drug, contact time with the gel, volume of the sample on the gel, storage temperature, and gel type. Users should consider these factors when evaluating the use of gel separator tubes for drug testing and monitoring. See Drug Adsorption in the References section.
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D Special Instrument Requirements:
Not applicable.
IV Device/System Characteristics:
A Device Description:
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. The tubes are comprised of a plastic tube (polyethylene terephthalate, PET) containing an inert gel separator and a clot activator, and a closure (either a BD Vacutainer® Hemogard™ closure assembly or a conventional stopper). Tube stoppers are lubricated with silicone to facilitate stopper insertion. The interior of the tube is spray-coated with a silica clot activator that is mixed with a silicone surfactant. In addition to the clot activator, the tube contains an inert gel separator that provides a mechanical barrier to separate the serum from the rest of the blood components. The tubes are available in 13x75mm, 13x100mm and 16x100mm configurations with draw volumes ranging from 3.5 to 10 mL. The amount of gel can vary based on tube size.
B Principle of Operation:
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes use controlled vacuum to draw a specific volume of blood into the sterile interior of the tube. Within the tube, a clot activator is present to help clot the red blood cells, isolating them from the serum and other blood components. The presence of a surfactant is intended to reduce adhesion of red blood cells and fibrin to the tube walls. The inert gel separator provides a mechanical barrier to separate the serum from the rest of the blood components. The density of the gel separator causes it to move upward during centrifugation to the serum-clot interface, where it forms a barrier separating serum from fibrin and red blood cells.
The tubes are compatible with BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices, Holders and Adapters. Once the vein of the patient has been penetrated using a standard needle, the collection tube is centered in the holder and pushed onto the needle, puncturing the stopper of the tube. Immediately after the blood has been drawn, the tube is gently inverted 5 times to mix the blood with the additive. Blood should be allowed to clot for a minimum of 30 minutes before centrifugation. The recommended centrifugation conditions are 1,100-1,300 RCF (relative centrifuge force or g) for 10 or 15 minutes (depending on the tube catalog number).
V Substantial Equivalence Information:
A Predicate Device Name(s):
BD Vacutainer Plus SST Serum Separator Tube
B Predicate 510(k) Number(s):
K023075
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K230855 | K023075 |
| --- | --- | --- |
| Device Trade Name | BD Vacutainer® Serum Separator (SST™) Blood Collection Tube | BD Vacutainer® SST Plus Tubes |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. | Same |
| Evacuated Blood Collection Tube | Yes | Same |
| Tube Dimension | 13x75 mm, 13x100 mm, 16x100 mm, 16x125 mm | Same |
| Tube Draw Volumes | 3.5mL - 10mL | Same |
| Sample Type | Serum | Same |
| Additive Type | Silica clot activator | Same |
| Additive Application/Quantity | Clot Activator Spray Dried Clot Activator amounts range from 2.1-4.3 mg/mL | Same |
| Tube Material | PET (polyethylene terephthalate) plastic | Same |
| Sterilization Method | Gamma Irradiation | Same |
| General Device Characteristic Differences | | |
| Sterility Assurance Level (SAL) | 10-3: 13x75mm Hemogard™, 16x100mm Conventional, 16x125mm Conventional | 10-3: 13x75mm Hemogard™, 13x100mm Hemogard™, 16x100mm Conventional, 16x125mm Conventional |
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| Device & Predicate Device(s): | K230855 | K023075 |
| --- | --- | --- |
| | 10^{-3} or 10^{-6}: 13x100mm
Hemogard™ | |
| Shelf Life | 5mL BD SST: 12 months
7.5 BD SST: 10 months | 12 months |
VI Standards/Guidance Documents Referenced:
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- EN ISO 14971:2019 Medical Devices – Application of risk management to medical devices
- ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
- ANSI AAMI ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ANSI/AAMI/ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- ANSI/AAMI/ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Routine Chemistry Analytes
A study was conducted to evaluate repeatability (within tube), lot-to-lot reproducibility and tube-to-tube reproducibility of BD Vacutainer® SST™ Blood Collection Tubes for select routine chemistry analytes. Blood was collected from each subject (n=47) into 6 BD SST™ Tubes. Specimens were tested in duplicate per tube with 2 tubes per lot across 3 lots on two instrument platforms (Beckman Coulter DxC 680i and Roche Cobas 6000) for the following select chemistry analytes: alanine aminotransferase (ALT), total bilirubin (TBIL), calcium (Ca), chloride (CL), glucose (GLUC), phosphorus (Phos), potassium (K), total protein (TP), triglycerides (Trig), complement C3 (C3), cortisol (CORT), free thyroxine (Free T4), immunoglobulin G (IgG), lactate dehydrogenase (LDH), testosterone (TESTO), prostate specific antigen (PSA), and thyroxine (Total T4). Contrived samples were also prepared in an effort to cover extreme levels for the following analytes: Ca, CL, GLUC, K, LDH, Phos, and
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TBIL. Total, Between-Lot, and Between-Tube variability for each instrument platform are presented in the tables below.
Precision Summary (%CV) on Beckman Coulter DxC for representative chemistry analytes:
| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| ALT (U/L) | 33.5 | Between Lots | 0.7 | 0%, 1.1% |
| | | Between Tubes | 0.2 | 0%, 0.9% |
| | | Within Tubes | 1.9 | 1.7%, 2.2% |
| | | Total | 2.1 | 1.6%, 2.9% |
| C3 (mg/dL) | 142.59 | Between Lots | 0.5 | 0%, 0.7% |
| | | Between Tubes | 0.2 | 0%, 0.6% |
| | | Within Tubes | 1.2 | 1.1%, 1.4% |
| | | Total | 1.4 | 1.1%, 1.9% |
| Ca (mg/dL) | 9.49 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0.2 | 0.1%, 0.3% |
| | | Within Tubes | 0.5 | 0.4%, 0.5% |
| | | Total | 0.5 | 0.4%, 0.7% |
| CL (mmol/L) | 102.1 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0.1 | 0%, 0.2% |
| | | Within Tubes | 0.4 | 0.4%, 0.5% |
| | | Total | 0.5 | 0.4%, 0.7% |
| CORT (μg/dL) | 10.948 | Between Lots | 1.7 | 0%, 2.5% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 4.3 | 4%, 4.8% |
| | | Total | 4.7 | 3.6%, 6.5% |
| Free T4 (ng/dL) | 0.993 | Between Lots | 0.3 | 0%, 2% |
| | | Between Tubes | 2.2 | 0%, 3.1% |
| | | Within Tubes | 4.3 | 3.8%, 4.8% |
| | | Total | 4.8 | 3.7%, 6.8% |
| GLUC (mg/dL) | 124.8 | Between Lots | 0.7 | 0%, 1.1% |
| | | Between Tubes | 0.8 | 0%, 1.1% |
| | | Within Tubes | 1.6 | 1.4%, 1.8% |
| | | Total | 1.9 | 1.5%, 2.6% |
| IgG (mg/dL) | 1056.6 | Between Lots | 0.5 | 0%, 0.7% |
| | | Between Tubes | 0 | 0%, 0.6% |
| | | Within Tubes | 1.3 | 1.2%, 1.5% |
| | | Total | 1.4 | 1.1%, 2% |
| K (mmol/L) | 4.13 | Between Lots | 1.3 | 0.8%, 1.6% |
| | | Between Tubes | 1.1 | 0.9%, 1.3% |
| | | Within Tubes | 0.7 | 0.6%, 0.8% |
| | | Total | 1.9 | 1.5%, 2.5% |
| LDH (U/L) | 160.5 | Between Lots | 1.1 | 0%, 1.6% |
| | | Between Tubes | 1.6 | 1.3%, 1.9% |
| | | Within Tubes | 1.2 | 1.1%, 1.4% |
| | | Total | 2.4 | 1.9%, 3.3% |
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| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| Phos (mg/dL) | 3.6 | Between Lots | 0.1 | 0%, 0.6% |
| | | Between Tubes | 0.6 | 0%, 1% |
| | | Within Tubes | 1.5 | 1.3%, 1.7% |
| | | Total | 1.6 | 1.3%, 2.2% |
| PSA (ng/mL) | 2.041 | Between Lots | 0.9 | 0%, 4/4% |
| | | Between Tubes | 7.2 | 5.3%, 8.7% |
| | | Within Tubes | 8.1 | 7.4%, 9% |
| | | Total | 10.9 | 8.8%, 14.3% |
| TBIL (mg/dL) | 1.14 | Between Lots | 2.2 | 0%, 3.8% |
| | | Between Tubes | 2.9 | 0%, 4.4% |
| | | Within Tubes | 6.5 | 5.8%, 7.3% |
| | | Total | 7.5 | 5.8%, 10.4% |
| TESTO (ng/dL) | 2.89 | Between Lots | 3.6 | 1.3%, 4.9% |
| | | Between Tubes | 5.2 | 4.3%, 6.1% |
| | | Within Tubes | 3.4 | 3.1%, 3.8% |
| | | Total | 7.2 | 5.9%, 9.5% |
| Total T4 (μg/dL) | 9.469 | Between Lots | 0.7 | 0%, 1.8% |
| | | Between Tubes | 1.4 | 0%, 2.4% |
| | | Within Tubes | 4 | 3.6%, 4.5% |
| | | Total | 4.3 | 3.4%, 6.1% |
| TP (g/dL) | 7.39 | Between Lots | 0.3 | 0%, 0.5% |
| | | Between Tubes | 0.4 | 0%, 0.6% |
| | | Within Tubes | 1 | 0.9%, 1.1% |
| | | Total | 1.1 | 0.9%, 1.5% |
| Trig (mg/dL) | 157.1 | Between Lots | 0.7 | 0.1%, 1% |
| | | Between Tubes | 0.6 | 0%, 0.9% |
| | | Within Tubes | 1.3 | 1.2%, 1.5% |
| | | Total | 1.6 | 1.3%, 2.3% |
Precision Summary (%CV) on Roche cobas 6000 for representative chemistry analytes:
| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| ALT (U/L) | 30.9 | Between Lots | 0.8 | 0%, 1.1% |
| | | Between Tubes | 0.3 | 0%, 0.9% |
| | | Within Tubes | 1.8 | 1.6%, 2.1% |
| | | Total | 2 | 1.6%, 2.8% |
| C3 (mg/dL) | 134 | Between Lots | 0.2 | 0%, 0.5% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 1.2 | 1.1%, 1.4% |
| | | Total | 1.2 | 1%, 1.7% |
| Ca (mg/dL) | 9.52 | Between Lots | 0.2 | 0%, 0.3% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 0.8 | 0.7%, 0.9% |
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| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| | | Total | 0.8 | 0.6%, 1.1% |
| Cl
(mmol/L) | 101.89 | Between Lots | 0.2 | 0%, 0.4% |
| | | Between Tubes | 0.1 | 0%, 0.4% |
| | | Within Tubes | 0.8 | 0.7%, 0.9% |
| | | Total | 0.8 | 0.6%, 1.1% |
| CORT
(μg/dL) | 10.219 | Between Lots | 1.2 | 0.7%, 1.5% |
| | | Between Tubes | 0.4 | 0%, 0.9% |
| | | Within Tubes | 1.7 | 1.5%, 1.9% |
| | | Total | 2.1 | 1.6%, 3% |
| Free T4
(ng/dL) | 1.2546 | Between Lots | 0.2 | 0%, 0.5% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 1.4 | 1.3%, 1.5% |
| | | Total | 1.4 | 1.1%, 2% |
| Gluc (mg/dL) | 126.1 | Between Lots | 0.7 | 0%, 1% |
| | | Between Tubes | 1 | 0.7%, 1.2% |
| | | Within Tubes | 1 | 0.9%, 1.1% |
| | | Total | 1.6 | 1.3%, 2.2% |
| IgG
(mg/dL) | 1084 | Between Lots | 0.5 | 0%, 0.7% |
| | | Between Tubes | 0 | 0%, 0.6% |
| | | Within Tubes | 1.3 | 1.2%, 1.5% |
| | | Total | 1.4 | 1.1%, 2% |
| K
(mmol/L) | 4.29 | Between Lots | 1.3 | 0.8%, 1.7% |
| | | Between Tubes | 1.1 | 0.8%, 1.3% |
| | | Within Tubes | 1 | 0.9%, 1.2% |
| | | Total | 2 | 1.6%, 2.7% |
| LDH
(U/L) | 202.4 | Between Lots | 0.9 | 0%, 1.4% |
| | | Between Tubes | 1.7 | 1.4%, 2% |
| | | Within Tubes | 1.1 | 1%, 1.2% |
| | | Total | 2.3 | 1.8%, 3.2% |
| Phos
(mg/dL) | 3.32 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0.5 | 0%, 0.8% |
| | | Within Tubes | 1.4 | 1.3%, 1.6% |
| | | Total | 1.5 | 1.2%, 2% |
| PSA
(ng/mL) | 3.3604 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 3.2 | 2.9%, 3.5% |
| | | Total | 3.2 | 2.5%, 4.4% |
| TBIL
(mg/dL) | 0.9 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 4.1 | 3.8%, 4.5% |
| | | Total | 4.1 | 3.2%, 5.7% |
| TESTO
(ng/dL) | 3.6217 | Between Lots | 2.3 | 0%, 3.5% |
| | | Between Tubes | 4 | 3%, 4.8% |
| | | Within Tubes | 3.9 | 3.6%, 4.4% |
| | | Total | 6.1 | 4.9%, 8% |
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| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| Total T4 (μg/dL) | 7.795 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 2.2 | 2%, 2.4% |
| | | Total | 2.2 | 1.7%, 3% |
| TP (g/dL) | 7.27 | Between Lots | 0.2 | 0%, 0.5% |
| | | Between Tubes | 0.2 | 0%, 0.5% |
| | | Within Tubes | 1 | 0.9%, 1.2% |
| | | Total | 1.1 | 0.9%, 1.5% |
| Trig (mg/dL) | 160.1 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0.5 | 0%, 0.7% |
| | | Within Tubes | 1.1 | 1%, 1.3% |
| | | Total | 1.2 | 1%, 1.7% |
## Therapeutic Drug Monitoring
A study was conducted to evaluate the clinical performance of BD Vacutainer® SST™ Blood Collection Tubes for repeatability (within tube), lot-to-lot reproducibility and tube-to-tube reproducibility for therapeutic drug testing. 25 participants were enrolled. Blood was collected from each participant into eight 10-mL BD Vacutainer® No Additive tubes for a total blood volume of 80 mL. Samples were prepared with spiking material and transferred into the study tubes for centrifuging, handling, and testing. Testing was performed for acetaminophen and vancomycin on the Beckman Coulter DxC 680i and Roche Cobas® 6000.
Precision Summary (%CV) on Beckman Coulter DxC 680i:
| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| ACET | 114.52 | Between Lots | 0 | 0%, 0% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 2.8 | 2.6%, 3.1% |
| | | Total | 2.8 | 2.2%, 3.9% |
| VANCO | 47.094 | Between Lots | 0.7 | 0%, 1.9% |
| | | Between Tubes | 2.9 | 2.1%, 3.5% |
| | | Within Tubes | 2.5 | 2.2%, 2.8% |
| | | Total | 3.9 | 3%, 5.4% |
Precision Summary (%CV) on Roche cobas® 6000:
| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| ACET | 97.87 | Between Lots | 0.4 | 0%, 0.9% |
| | | Between Tubes | 0.7 | 0%, 1.1% |
| | | Within Tubes | 1.7 | 1.5%, 1.9% |
| | | Total | 1.9 | 1.5, 2.7% |
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| Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- |
| VANCO | 49.81 | Between Lots | 1.8 | 1%, 2.3% |
| | | Between Tubes | 0 | 0%, 0% |
| | | Within Tubes | 2.8 | 2.6%, 3.1% |
| | | Total | 3.3 | 2.6%, 4.7% |
Information was provided to support testing for valproic acid.
2. Linearity:
Not applicable.
3. Analytical Specificity/Interference:
Benchtop studies were conducted to evaluate interference from stopper materials over the sample storage time. Study protocols, acceptance criteria and results for this study were provided and found to be acceptable.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
a. Shelf-Life
Real Time stability testing of the BD Vacutainer® SST™ Blood Collection Tubes showed that the candidate device is stable for 10-12 months when stored at 4 to 25°C. The stability study protocol and acceptance criteria has been reviewed and found to be acceptable.
b. Analyte Stability
Multiple analyte stability studies were conducted to assess the analyte within-tube stability for representative chemistry analytes and certain therapeutic drugs in the BD Vacutainer® SST™ Blood Collection Tubes. Within-tube stability was assessed in the 5.0 mL and 7.5 mL BD Tubes after 18-hour storage at room temperature for Glucose and CO₂ only, and for all other chemistry analytes at 24-hour storage at room temperature. In addition, within-tube stability after 3 days and 7 days of refrigerated storage was assessed for all analytes except Glucose and CO₂. For TDMs, within-tube stability was assessed after 24 and 48 hours storage at room temperature (23-27°C), and also after storage at refrigerated temperature (2-8°C) for an additional 5 days for a total of 7 days of storage. Analyte stability was tested on a minimum of two instrument platforms. The study protocols and acceptance criteria have been reviewed and found to be acceptable. These studies support the following storage instructions included in the device labeling:
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| Analyte* | Storage Conditions | Analyte Stability |
| --- | --- | --- |
| Albumin (ALB)
Alkaline Phosphatase (ALKP)
Amylase (AMY)
Aspartate Aminotransferase (AST)
Blood Urea Nitrogen (BUN)
Calcium (Ca)
Cholesterol (Chol)
Creatine Kinase (CK)
Creatinine (Creat)
Direct Bilirubin (DBIL)
Gamma Glutamyltransferase (GGT)
High Density Lipoprotein (HDL)
Iron (Fe)
Lactate Dehydrogenase (LDH)
Lipase (Lip)
Low Density Lipoprotein (LDL)
Magnesium (Mg)
Phosphorus (Phos)
Potassium (K)
Total Bilirubin (TBIL)
Total Protein (TP)
Triglycerides (Trig)
Uric Acid (UA) | Storage at room temperature (23-27 °C) for the first 24 hours, then Refrigerated storage (2-8 °C) for an additional 6 days | 7 days |
| Alanine Aminotransferase (ALT)
Sodium (Na) | Storage at room temperature (23-27 °C) for the first 24 hours, then Refrigerated storage (2-8 °C) for an additional 2 days | 3 days |
| Beta Human Chorionic Gonadotropin (BHCG)
Chloride (CL)
Complement C3 (C3)
Cortisol (CORT)
C-Reactive Protein (CRP)
Creatine Kinase-MB Fraction (CKMB)
Estradiol (E2)
Ferritin (FERR)
Follicle Stimulating Hormone (FSH)
Free Thyroxine (Free T4)
Free Triiodothyronine (Free T3)
Glucose (GLUC)
Haptoglobin (HAPT) | Storage at room temperature (23-27 °C) | 24 hours |
{11}
| Analyte* | Storage Conditions | Analyte Stability |
| --- | --- | --- |
| Immunoglobulin A (IgA)
Immunoglobulin G (IgG)
Immunoglobulin M (IgM)
Luteinizing Hormone (LH)
N-terminal Pro B-type Natriuretic Peptide (PBNP)
Progesterone (PROG)
Prostate Specific Antigen (PSA)
Testosterone (TESTOS)
Thyroid Stimulating Hormone (TSH)
Total Thyroxine (Total T4)
Total Triiodothyronine (Total T3)
Transferrin (TRF)
Troponin I (TnI) (conventional assay)
Troponin T (TnT)
Vitamin B12 (VIT B12)
Vitamin D (VIT D) | | |
| Carbon Dioxide (CO2) | Storage at room temperature (23-27 °C) | 18 hours |
| Acetaminophen (ACET) | Storage at room temperature (23-27 °C) for the first 48 hours, then Refrigerated storage (2-8 °C) for an additional 5 days | 7 days |
| Valproic Acid (VAL)
Vancomycin (VANCO) | Storage at room temperature (23-27 °C) | 48 hours |
*Based on the results of BD within-tube stability testing, it is recommended that Folate and Troponin I (high sensitivity assay) be tested immediately.
c. Additional bench testing on the candidate device
Benchtop studies were conducted to assess draw volume, X-value, 2nd stopper pullout, stopper/shield separation, stopper leakage, tube leakage, breakage resistance during drop testing, breakage resistance during centrifugation testing, barrier formation and packaging performance during shipping and handling. The study protocols were reviewed, and performance was considered acceptable.
6. Detection Limit:
Not applicable
7. Assay Cut-Off:
Not applicable.
K230855 - Page 12 of 22
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K230855 - Page 13 of 22
# B Comparison Studies:
1. Method Comparison with Predicate Device:
See Clinical Studies in section C.3. below.
2. Matrix Comparison:
Not applicable. These tubes are for serum only.
# C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Routine Chemistry Analytes
A study was conducted to evaluate equivalence between the BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (5.0 and 7.5 mL) and Greiner Bio-One Vacuette® Z Serum Separator Clot Activator Blood Collection Tubes (5.0 mL and 7.0 mL, respectively) for testing representative chemistry analytes.
A total of 168 participants were enrolled in the study. Blood was collected from each participant into the required study tubes using standard phlebotomy techniques. In addition, contrived samples were prepared in an effort to obtain results that spanned the analytical measurement range for the tested analytes.
Samples were tested on two different instrument platforms (Beckman Coulter UniCel DxC AU480 and Roche cobas Integra 400+). For each analyte and tube comparison, data was analyzed using Passing Bablok (PB), Deming (D) or weighted Deming (WD) regression. Biases between tube types were estimated with 95% confidence intervals. Regression analyses for a representative tube using each instrument platform are provided in the tables below.
Regression Parameter Estimates: Beckman Coulter UniCel DxC AU480, for the comparison 5.0 mL BD SST™ vs. 5.0 mL Greiner Serum
| Analyte | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient | Regression |
| --- | --- | --- | --- | --- |
| ALB | -0.01 (-0.24, 0.05) | 1 (0.98, 1.05) | 0.991 | PB |
| ALKP | 0 (-1, 1.83) | 1 (0.97, 1) | 0.999 | PB |
| ALT | 0.06 (-0.56, 0.67) | 0.99 (0.96, 1.01) | 0.999 | WD |
{13}
| Analyte | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient | Regression |
| --- | --- | --- | --- | --- |
| AMY | 0 (-0.05, 1) | 1 (1, 1) | 0.999 | PB |
| AST | 0.02 (-0.59, 0.63) | 1 (0.97, 1.03) | 1 | WD |
| BUN | -0.1 (-0.1, 0.23) | 1 (0.98, 1) | 0.998 | PB |
| Ca | 0 (-0.1, 0.68) | 1 (0.93, 1) | 0.974 | PB |
| Chol | 0 (-3.03, 2.18) | 1 (0.99, 1.02) | 0.995 | PB |
| CK | 0 (-0.88, 0.94) | 1 (0.99, 1.01) | 0.999 | PB |
| CL | 0 (-1, 10.1) | 1 (0.9, 1) | 0.986 | PB |
| CO2 | -1 (-2.75, 0) | 1 (1, 1.1) | 0.946 | PB |
| Creat | 0.01 (0, 0.04) | 1 (0.96, 1) | 1 | PB |
| DBIL | 0 (0, 0) | 0.99 (0.99, 1) | 1 | D |
| Fe | 0 (-0.84, 1.06) | 1 (0.99, 1.01) | 0.999 | PB |
| GGT | -0.21 (-0.88, 0.46) | 0.99 (0.97, 1.01) | 1 | WD |
| GLUC | 0.86 (-1, 3.3) | 0.99 (0.96, 1) | 0.999 | PB |
| HDL | 0.44 (-0.64, 1.53) | 1 (0.97, 1.02) | 0.997 | WD |
| K | -0.1 (-0.1, 0.51) | 1 (0.87, 1) | 0.845 | PB |
| LDH | -1 (-3.36, 5.9) | 1 (0.95, 1.02) | 0.987 | PB |
| LDL | 0 (-1, 2.23) | 1 (0.98, 1.01) | 0.991 | PB |
| Lip | 0.47 (-1.71, 2.64) | 0.99 (0.92, 1.06) | 0.996 | WD |
| Mg | -0.13 (-0.22, -0.04) | 1.02 (0.98, 1.06) | 0.993 | D |
| Na | 0 (-1, 1.94) | 1 (0.99, 1) | 0.99 | PB |
| Phos | 0 (-0.1, 0.25) | 1 (0.91, 1) | 0.988 | PB |
| TBIL | -0.01 (-0.03, 0.01) | 1 (0.96, 1.05) | 1 | WD |
| TP | 0 (-0.1, 0.17) | 1 (0.98, 1) | 0.982 | PB |
| Trig | 0 (-2.42, 0.06) | 1 (1, 1.01) | 0.999 | PB |
| UA | -0.07 (-0.14, 0.01) | 1.02 (1, 1.03) | 0.997 | WD |
$\mathrm{PB} =$ Passing Bablok, $\mathrm{WD} =$ Weighted Deming, $\mathrm{D} =$ Deming
Regression Parameter Estimates: Roche cobas Integra $400+$ , for the comparison $5.0~\mathrm{mL}$ BD $\mathrm{SST}^{\mathrm{TM}}$ vs. $5.0~\mathrm{mL}$ Greiner Serum
| Analyte | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient | Regression |
| --- | --- | --- | --- | --- |
| ALB | -0.01 (-0.16, 0.14) | 0.99 (0.96, 1.03) | 0.954 | WD |
| ALKP | 0.39 (-1.25, 1.9) | 1 (0.98, 1.02) | 0.998 | PB |
| ALT | 0.26 (-0.1, 0.74) | 0.98 (0.96, 1) | 0.998 | PB |
| AMY | 0.13 (-0.51, 0.71) | 0.99 (0.98, 1.01) | 0.997 | PB |
| AST | 0.27 (-0.1, 0.76) | 0.99 (0.96, 1) | 1 | PB |
| BUN | 0.1 (-0.1, 0.38) | 0.99 (0.97, 1) | 0.996 | PB |
| Ca | 0 (-1.5, 0) | 1 (1, 1.15) | 0.918 | PB |
| Chol | 1 (-4.87, 2.24) | 1 (0.99, 1.03) | 0.995 | PB |
| CK | 0.38 (-0.5, 0.82) | 1 (0.99, 1.01) | 0.983 | PB |
| CL | 7.35 (0.96, 15.52) | 0.93 (0.85, 0.99) | 0.995 | PB |
| CO2 | -0.32 (-1.91, 1.1) | 1.02 (0.95, 1.09) | 0.961 | PB |
| Creat | 0 (-0.03, 0) | 1 (1, 1.03) | 1 | PB |
K230855 - Page 14 of 22
{14}
| Analyte | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient | Regression |
| --- | --- | --- | --- | --- |
| DBIL | 0 (0, 0) | 1 (1, 1.01) | 0.999 | PB |
| Fe | 0.81 (-0.56, 2.89) | 1 (0.97, 1.01) | 0.999 | PB |
| GGT | 0 (-0.21, 0.27) | 1 (0.99, 1.01) | 0.999 | PB |
| GLUC | 1.14 (-1, 3.85) | 0.99 (0.96, 1) | 0.998 | PB |
| HDL | 0 (-0.77, 0.5) | 1 (1, 1.02) | 0.992 | PB |
| K | 0.18 (-0.04, 0.5) | 0.95 (0.87, 1) | 0.981 | PB |
| LDH | 1.48 (-3.68, 8.42) | 0.99 (0.95, 1.02) | 0.991 | PB |
| LDL | 0 (-1.26, 1.68) | 1 (0.99, 1.02) | 0.997 | PB |
| Lip | -0.05 (-0.56, 0.39) | 1 (0.99, 1.02) | 0.999 | PB |
| Mg | -0.1 (-0.1, 0.06) | 1 (0.93, 1) | 0.96 | PB |
| Na | 0.6 (-5.17, 11.41) | 1 (0.92, 1.04) | 0.995 | PB |
| Phos | -0.1 (-0.1, 0.15) | 1 (0.93, 1) | 0.989 | PB |
| TBIL | 0 (-0.04, 0.01) | 1 (0.98, 1.08) | 1 | PB |
| TP | 0 (0, 0.45) | 1 (0.93, 1) | 0.986 | PB |
| Trig | 0 (-1.42, 0.86) | 1 (0.99, 1.01) | 0.999 | PB |
| UA | -0.01 (-0.11, 0.09) | 0.99 (0.97, 1.02) | 0.982 | WD |
Special Chemistry Analytes and Cardiac Markers (PAS-18SUST028)
A study was conducted to evaluate the equivalence of BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (5.0 and 7.5 mL) in comparison with Greiner Bio-One Vacuette® Z Serum Separator Clot Activator Blood Collection Tubes (5.0 mL and 7.0 mL, respectively) for testing special chemistry analytes and cardiac markers.
A total of 495 participants were enrolled in the study. Blood was collected from each participant into the required study tubes using standard phlebotomy techniques. In addition, contrived samples were prepared in an effort to cover the analytical measurement range. Testing was initiated within four hours of sample collection.
Samples were tested on at least two different instrument platforms for each analyte tested:
| Instrument | Analyte | Abbreviation |
| --- | --- | --- |
| 3, 4, 6 | Beta Human Chorionic Gonadotropin | BHCG |
| 3, 6 | C-reactive Protein | CRP |
| 3, 4, 6 | Creatine Kinase-MB Fraction | CKMB |
| 3, 6 | Complement C3 | C3 |
| 3, 7 | Cortisol | CORT |
| 3, 6 | Estradiol | E2 |
| 3, 4, 6 | Ferritin | FERR |
| 3, 6 | Folate | FOLATE |
| 3, 6 | Follicle Stimulating Hormone | FSH |
| 3, 4, 6 | Free Thyroxine | Free T4 |
| 3, 6 | Free Triiodothyronine | Free T3 |
| 3, 6 | Haptoglobin | HAPT |
| 1, 2, 6 | High sensitivity Troponin I | hsTnI |
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| Instrument | Analyte | Abbreviation |
| --- | --- | --- |
| 3, 6 | Immunoglobulin A | IgA |
| 3, 6 | Immunoglobulin G | IgG |
| 3, 6 | Immunoglobulin M | IgM |
| 3, 4, 6 | Luteinizing Hormone | LH |
| 3, 6 | N-terminal Pro B-type Natriuretic Peptide | PBNP |
| 3, 4, 6 | Progesterone | PROG |
| 3, 7 | Prostate Specific Antigen | PSA |
| 3, 6 | Testosterone | TESTOS |
| 3, 4, 6 | Thyroid Stimulating Hormone | TSH |
| 3, 6 | Total Thyroxine | Total T4 |
| 3, 7 | Total Triiodothyronine | Total T3 |
| 3, 6 | Transferrin | TRF |
| 3, 6 | Vitamin B12 | VIT B12 |
| 3, 4, 7 | Vitamin D | VIT D |
1 – Beckman Coulter UniCel® DxI 800
2 – Beckman Coulter Access® 2
3 – Ortho Clinical Diagnostics (OCD) Vitros 5600
4 – Roche cobas® e411
5 – Roche cobas® e601
6 – Siemens Dimensions Vista® 1500
7 – Siemens ADVIA Centaur® XP
For each analyte and tube comparison, data was analyzed using Passing Bablok regression or Deming regression (weighted or unweighted). Biases between tube types were estimates with 95% intervals. Regression analyses for a representative tube comparison are provided in the tables below.
Regression Parameters for 5.0 mL BD vs 5.0 mL Greiner Serum
| Instrument | Analyte | N | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| OCD Vitros 5600 (Part A) | BHCG | 100 | 0.02 (0.01, 0.04) | 0.99 (0.99, 1) | 1 |
| Siemens Dimension Vista 1500 | BHCG | 110 | 0 (-0.02, 0.02) | 0.99 (0.98, 1) | 0.996 |
| OCD Vitros 5600 (Part A) | C3 | 148 | -0.57 (-1.63, 0.49) | 0.99 (0.98, 1) | 0.995 |
| Siemens Dimension Vista 1500 | C3 | 168 | 0.67 (-1.13, 2.47) | 0.96 (0.95, 0.98) | 0.979 |
| OCD Vitros 5600 (Part A) | CKMB | 132 | 0.05 (-0.01, 0.1) | 1.03 (1, 1.04) | 1 |
| Siemens Dimension Vista 1500 | CKMB | 116 | 0.01 (-0.06, 0.11) | 0.99 (0.99, 1) | 1 |
| OCD Vitros 5600 (Part A) | CORT | 112 | 0 (-0.01, 0.01) | 1.01 (1, 1.01) | 0.999 |
| Siemens ADVIA Centaur XP | CORT | 151 | -0.03 (-0.17, 0.11) | 1.01 (0.99, 1.03) | 0.994 |
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K230855 - Page 17 of 22
| Instrument | Analyte | N | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| OCD Vitros 5600 (Part A) | CRP | 113 | -0.1 (-0.1, -0.08) | 1 (0.99, 1) | 0.998 |
| Siemens Dimension Vista 1500 | CRP | 118 | 0.1 (-0.08, 0.25) | 0.98 (0.97, 1) | 0.998 |
| OCD Vitros 5600 (Part A) | E2 | 123 | 13.35 (10, 17.61) | 1.03 (1.01, 1.05) | 0.999 |
| Siemens Dimension Vista 1500 | E2 | 133 | 0.86 (-0.57, 1.78) | 0.98 (0.96, 1) | 0.981 |
| OCD Vitros 5600 (Part A) | FERR | 113 | -0.1 (-0.3, 0.1) | 1.01 (1, 1.02) | 0.999 |
| Siemens Dimension Vista 1500 | FERR | 116 | -0.02 (-0.15, 0.11) | 1 (0.99, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | FOLATE | 122 | 0.2 (-0.03, 0.59) | 1 (0.95, 1.04) | 0.971 |
| Siemens Dimension Vista 1500 | FOLATE | 112 | 0.15 (-0.27, 0.52) | 1.02 (0.99, 1.07) | 0.982 |
| OCD Vitros 5600 (Part A) | FSH | 115 | -0.11 (-0.29, 0.07) | 0.95 (0.93, 0.97) | 0.999 |
| Siemens Dimension Vista 1500 | FSH | 112 | 0.02 (-0.03, 0.07) | 1 (0.99, 1.01) | 1 |
| OCD Vitros 5600 (Part A) | Free T3 | 123 | 0.18 (-0.04, 0.41) | 0.97 (0.93, 1.01) | 0.999 |
| Siemens Dimension Vista 1500 | Free T3 | 127 | 0.04 (-0.1, 0.17) | 1.01 (0.95, 1.06) | 0.998 |
| OCD Vitros 5600 (Part A) | Free T4 | 151 | 0 (0, 0) | 1 (1, 1) | 0.998 |
| Siemens Dimension Vista 1500 | Free T4 | 139 | 0 (0, 0.01) | 1 (1, 1) | 0.998 |
| OCD Vitros 5600 (Part A) | HAPT | 138 | 0.5 (-1, 2) | 1 (0.99, 1.02) | 0.997 |
| Siemens Dimension Vista 1500 | HAPT | 156 | 0.01 (-0.01, 0.02) | 0.98 (0.97, 1) | 0.994 |
| Beckman UniCel DxI | hsTnI | 110 | -0.09 (-0.24, 0.07) | 0.98 (0.97, 1) | 0.998 |
| Siemens Dimension Vista 1500 | hsTnI | 116 | 0.01 (-0.14, 0.22) | 1 (0.99, 1.01) | 1 |
| OCD Vitros 5600 (Part A) | IgA | 121 | -2.17 (-4.41, 0.06) | 1.02 (1.01, 1.04) | 0.996 |
| Siemens Dimension Vista 1500 | IgA | 148 | -0.64 (-2.65, 1.37) | 0.99 (0.97, 1) | 0.996 |
| OCD Vitros 5600 (Part A) | IgG | 130 | 7.15 (-9.6, 23.9) | 1 (0.97, 1.02) | 0.99 |
| Siemens Dimension Vista 1500 | IgG | 162 | -7.01 (-18.3, 4.28) | 1 (0.99, 1.02) | 0.995 |
| OCD Vitros 5600 (Part A) | IgM | 118 | 0.01 (-0.63, 0.66) | 1 (0.99, 1.01) | 1 |
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K230855 - Page 18 of 22
| Instrument | Analyte | N | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Siemens Dimension Vista 1500 | IgM | 146 | -1.01 (-2.61, 0.59) | 1.01 (0.99, 1.03) | 0.999 |
| OCD Vitros 5600 (Part A) | LH | 126 | -0.07 (-0.13, -0.02) | 0.95 (0.94, 0.96) | 0.997 |
| Siemens Dimension Vista 1500 | LH | 125 | 0 (0, 0.03) | 1 (0.99, 1) | 0.998 |
| OCD Vitros 5600 (Part A) | PBNP | 117 | 0.97 (0.14, 1.79) | 0.98 (0.97, 0.99) | 0.998 |
| Siemens Dimension Vista 1500 | PBNP | 110 | 0.2 (-0.12, 0.53) | 0.99 (0.99, 1) | 0.999 |
| OCD Vitros 5600 (Part A) | PROG | 117 | 0.11 (0.08, 0.13) | 1.01 (1, 1.01) | 0.995 |
| Siemens Dimension Vista 1500 | PROG | 118 | 0.06 (0.05, 0.07) | 1.01 (1, 1.02) | 0.999 |
| OCD Vitros 5600 (Part A) | PSA | 124 | 0 (0, 0) | 1 (1, 1) | 1 |
| Siemens ADVIA Centaur XP | PSA | 103 | -0.01 (-0.01, 0.01) | 1.01 (1, 1.02) | 1 |
| OCD Vitros 5600 (Part A) | T3 | 140 | 1.3 (-0.25, 2.84) | 1.08 (1.06, 1.09) | 0.996 |
| Siemens ADVIA Centaur XP | T3 | 138 | -0.01 (-0.08, 0.07) | 1.02 (0.94, 1.09) | 0.994 |
| OCD Vitros 5600 (Part A) | T4 | 140 | -0.06 (-0.14, 0.03) | 1.01 (1, 1.02) | 0.998 |
| Siemens Dimension Vista 1500 | T4 | 139 | 0.3 (-0.18, 0.5) | 1 (0.97, 1.06) | 0.979 |
| OCD Vitros 5600 (Part A) | TESTOS | 119 | 3.58 (2.57, 4.52) | 1.08 (1.06, 1.1) | 0.998 |
| Siemens Dimension Vista 1500 | TESTOS | 121 | 0.08 (-0.02, 1.11) | 0.99 (0.98, 1) | 0.999 |
| Roche Cobas e601 | TnT | 110 | 0.06 (-0.26, 0.37) | 0.9 7 (0.96, 0.99) | 1 |
| OCD Vitros 5600 (Part A) | TRF | 147 | 1.51 (-4.84, 7.87) | 1 (0.97, 1.02) | 0.997 |
| Siemens Dimension Vista 1500 | TRF | 161 | 0.02 (-0.01, 0.05) | 0.99 (0.98, 1.01) | 0.995 |
| OCD Vitros 5600 (Part A) | TSH | 134 | -0.01 (-0.03, 0) | 0.99 (0.98, 1.01) | 1 |
| Siemens Dimension Vista 1500 | TSH | 158 | 0.02 (0, 0.04) | 0.95 (0.91, 0.99) | 0.997 |
| OCD Vitros 5600 (Part A) | VIT B12 | 126 | -9.41 (-14.85, -3.96) | 1.05 (1.03, 1.07) | 0.993 |
| Siemens Dimension Vista 1500 | VIT B12 | 141 | 1.14 (-9.5, 11.78) | 1 (0.98, 1.02) | 0.998 |
| OCD Vitros 5600 (Part A) | VIT D | 112 | 0.75 (-0.61, 1.94) | 0.92 (0.9, 0.95) | 0.993 |
{18}
Regression Parameters for 7.5 mL BD vs 7.0 mL Greiner Serum
| Instrument | Analyte | N | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Siemens ADVIA Centaur XP | VIT D | 130 | -0.56 (-1.89, 0.38) | 0.94 (0.91, 0.99) | 0.983 |
| Instrument | Analyte | Total Pairs | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| OCD Vitros 5600 (Part A) | BHCG | 103 | 0.08 (-0.24, 0.39) | 0.99 (0.99, 1) | 0.998 |
| Siemens Dimension Vista 1500 | BHCG | 109 | -0.01 (-0.02, 0.01) | 1.01 (1, 1.02) | 0.996 |
| OCD Vitros 5600 (Part A) | C3 | 147 | 0.54 (-0.58, 1.65) | 0.98 (0.97, 0.99) | 0.994 |
| Siemens Dimension Vista 1500 | C3 | 171 | -0.07 (-1.85, 1.71) | 0.98 (0.96, 1) | 0.98 |
| OCD Vitros 5600 (Part A) | CKMB | 134 | 0.01 (-0.01, 0.1) | 1.02 (1, 1.04) | 1 |
| Siemens Dimension Vista 1500 | CKMB | 119 | -0.01 (-0.08, 0.1) | 1.01 (1, 1.02) | 1 |
| OCD Vitros 5600 (Part A) | CORT | 114 | 0.02 (-0.07, 0.11) | 1.02 (1, 1.03) | 0.999 |
| Siemens ADVIA Centaur XP | CORT | 153 | 0.05 (-0.06, 0.16) | 1.01 (1, 1.03) | 0.994 |
| OCD Vitros 5600 (Part A) | CRP | 116 | 0 (-0.1, 0) | 1 (1, 1.02) | 0.999 |
| Siemens Dimension Vista 1500 | CRP | 120 | 0.11 (-0.16, 0.3) | 1 (0.99, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | E2 | 125 | 17.03 (13.78, 20.37) | 1.02 (1.01, 1.04) | 0.999 |
| Siemens Dimension Vista 1500 | E2 | 137 | 1.32 (-0.33, 2.49) | 0.98 (0.97, 1) | 0.999 |
| OCD Vitros 5600 (Part A) | FERR | 114 | 0.06 (-0.1, 0.23) | 1 (0.99, 1.01) | 0.999 |
| Siemens Dimension Vista 1500 | FERR | 117 | 0.09 (-0.08, 0.27) | 1 (0.99, 1) | 1 |
| OCD Vitros 5600 (Part A) | FOLATE | 125 | 0 (-0.44, 0.31) | 1 (0.96, 1.05) | 0.971 |
| Siemens Dimension Vista 1500 | FOLATE | 118 | -0.11 (-0.62, 0.3) | 1.03 (0.99, 1.07) | 0.986 |
| OCD Vitros 5600 (Part A) | FSH | 113 | -0.06 (-0.19, 0.06) | 0.93 (0.92, 0.95) | 0.999 |
| Siemens Dimension Vista 1500 | FSH | 116 | 0.08 (0.02, 0.13) | 0.99 (0.98, 1) | 1 |
| OCD Vitros 5600 (Part A) | Free T3 | 125 | 0.28 (0.15, 0.4) | 0.96 (0.94, 0.98) | 0.997 |
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K230855 - Page 20 of 22
| Instrument | Analyte | Total Pairs | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Siemens Dimension Vista 1500 | Free T3 | 131 | 0.04 (0.02, 0.07) | 1.02 (1.01, 1.02) | 0.998 |
| OCD Vitros 5600 (Part A) | Free T4 | 151 | 0 (0, 0) | 1 (1, 1) | 0.997 |
| Siemens Dimension Vista 1500 | Free T4 | 142 | 0.01 (-0.02, 0.01) | 1 (1, 1.03) | 0.998 |
| OCD Vitros 5600 (Part A) | HAPT | 139 | 0.31 (-1.06, 1.67) | 1 (0.98, 1.01) | 0.995 |
| Siemens Dimension Vista 1500 | HAPT | 160 | -0.01 (-0.03, 0) | 1.01 (1, 1.02) | 0.996 |
| Beckman UniCel DxI | hsTnI | 112 | -0.07 (-0.22, 0.04) | 0.98 (0.97, 0.99) | 1 |
| Siemens Dimension Vista 1500 | hsTnI | 117 | 0.01 (-0.11, 0.22) | 1 (0.99, 1.01) | 1 |
| OCD Vitros 5600 (Part A) | IgA | 122 | -0.57 (-2.25, 1.12) | 1 (0.99, 1.02) | 0.998 |
| Siemens Dimension Vista 1500 | IgA | 151 | -2.16 (-5.23, 0.91) | 1.01 (0.99, 1.02) | 0.997 |
| OCD Vitros 5600 (Part A) | IgG | 132 | 4.14 (-11.86, 20.14) | 1 (0.98, 1.01) | 0.997 |
| Siemens Dimension Vista 1500 | IgG | 165 | 5.29 (-6.53, 17.11) | 1 (0.98, 1.01) | 0.994 |
| OCD Vitros 5600 (Part A) | IgM | 117 | 0.11 (-0.94, 1.16) | 1 (0.98, 1.01) | 0.999 |
| Siemens Dimension Vista 1500 | IgM | 148 | 0.31 (-1.36, 1.99) | 1 (0.97, 1.02) | 0.999 |
| OCD Vitros 5600 (Part A) | LH | 125 | -0.03 (-0.09, 0.03) | 0.94 (0.93, 0.95) | 0.999 |
| Siemens Dimension Vista 1500 | LH | 126 | -0.01 (-0.03, 0.1) | 1 (1, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | PBNP | 118 | 0.36 (-0.21, 0.94) | 0.98 (0.97, 0.99) | 0.996 |
| Siemens Dimension Vista 1500 | PBNP | 111 | 0.1 (-0.04, 0.23) | 1 (0.99, 1) | 0.999 |
| OCD Vitros 5600 (Part A) | PROG | 119 | 0.11 (0.07, 0.15) | 1.01 (1, 1.02) | 0.999 |
| Siemens Dimension Vista 1500 | PROG | 121 | 0.09 (0.07, 0.11) | 1 (0.99, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | PSA | 125 | 0 (0, 0) | 1 (1, 1) | 1 |
| Siemens ADVIA Centaur XP | PSA | 102 | 0 (-0.01, 0.01) | 1 (0.99, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | Total T3 | 141 | 1.09 (-0.87, 3.04) | 1.06 (1.04, 1.08) | 0.997 |
| Siemens ADVIA Centaur XP | Total T3 | 141 | 0.02 (-0.05, 0.09) | 0.98 (0.92, 1.04) | 0.99 |
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| Instrument | Analyte | Total Pairs | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| OCD Vitros 5600 (Part A) | Total T4 | 142 | -0.02 (-0.06, 0.01) | 1.02 (1.01, 1.02) | 0.998 |
| Siemens Dimension Vista 1500 | Total T4 | 142 | 0.15 (-0.31, 0.51) | 1 (0.96, 1.04) | 0.98 |
| OCD Vitros 5600 (Part A) | TESTOS | 118 | 3.65 (2.93, 5.17) | 1.08 (1.06, 1.1) | 0.998 |
| Siemens Dimension Vista 1500 | TESTOS | 120 | 0.08 (0, 0.59) | 1 (0.99, 1) | 0.999 |
| Roche Cobas e601 | TnT | 112 | 0.16 (-0.16, 0.48) | 0.96 (0.93, 1) | 1 |
| OCD Vitros 5600 (Part A) | TRF | 147 | -0.75 (-3.92, 2.42) | 1.01 (0.99, 1.02) | 0.997 |
| Siemens Dimension Vista 1500 | TRF | 165 | -0.01 (-0.03, 0.02) | 1 (0.99, 1.01) | 0.995 |
| OCD Vitros 5600 (Part A) | TSH | 136 | 0 (-0.01, 0) | 0.99 (0.99, 1) | 1 |
| Siemens Dimension Vista 1500 | TSH | 161 | 0 (-0.02, 0.02) | 0.98 (0.96, 1.01) | 0.999 |
| OCD Vitros 5600 (Part A) | VIT B12 | 125 | -5.28 (-11.39, 0.83) | 1.03 (1, 1.05) | 0.989 |
| Siemens Dimension Vista 1500 | VIT B12 | 144 | 4.05 (-6.69, 14.8) | 1 (0.98, 1.02) | 0.998 |
| OCD Vitros 5600 (Part A) | VIT D | 110 | -1.1 (-2.2, 0.3) | 0.94 (0.89, 0.98) | 0.977 |
| Siemens ADVIA Centaur XP | VIT D | 132 | -0.78 (-2.48, 0.48) | 0.95 (0.9, 1.01) | 0.987 |
Therapeutic Drug Monitoring:
A study was conducted to evaluate the equivalence of BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (5.0 and 7.5 mL) in comparison with Greiner Bio-One Vacuette® Z Serum Separator Clot Activator Blood Collection Tubes (5.0 mL and 7.0 mL, respectively) for therapeutic drugs. The following therapeutic drug assays were tested: Acetaminophen, Valproic acid, and Vancomycin. In addition, contrived samples were prepared in an effort to cover the analytical measurement range. Testing of each drug was performed on the Beckman Coulter DxC 680i and Roche Cobas® 6000. For each analyte and tube comparison, Deming Regression (weighted or unweighted) or Passing-Bablok Regression was used. Representative data is provided below.
Regression Parameters: 7.5 mL BD Serum vs 7.0 mL Greiner Serum
| Instrument | Drug | Total Pairs | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter DxC 680i | ACET | 80 | 0.07 (-0.52, 0.65) | 1 (0.99, 1.01) | 0.999 |
| Roche cobas® 6000 | ACET | 77 | 0.01 (-0.19, 0.21) | 1 (0.99, 1) | 0.999 |
| Beckman Coulter DxC 680i | VAL | 80 | -0.51 (-1.98, 0.63) | 1.01 (0.99, 1.03) | 0.997 |
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| Roche cobas® 6000 | VAL | 80 | 0.52 (-0.37, 1.4) | 0.99 (0.97, 1) | 0.998 |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter DxC 680i | VANCO | 79 | 0.08 (-0.21, 0.48) | 0.99 (0.97, 1.01) | 0.994 |
| Roche cobas® 6000 | VANCO | 72 | 0.37 (-0.15, 0.69) | 0.98 (0.97, 1) | 0.975 |
Regression Parameters: 7.5 mL BD Serum vs 7.0 mL Greiner Serum
| Instrument | Drug | Total Pairs | Intercept (95% CI) | Slope (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter DxC 680i | ACET | 80 | -0.05 (-0.83, 0.73) | 0.99 (0.97, 1) | 0.999 |
| Roche cobas® 6000 | ACET | 77 | -0.04 (-0.17, 0.09) | 1 (0.99, 1) | 1 |
| Beckman Coulter DxC 680i | VAL | 80 | -0.45 (-1.47, 0.6) | 1 (0.98, 1.01) | 0.998 |
| Roche cobas® 6000 | VAL | 80 | -1.11 (-1.65, -0.57) | 1.02 (1, 1.03) | 0.996 |
| Beckman Coulter DxC 680i | VANCO | 79 | 0.1 (-0.28, 0.44) | 1 (0.98, 1.02) | 0.997 |
| Roche cobas® 6000 | VANCO | 71 | -0.04 (-0.47, 0.39) | 1 (0.99, 1.02) | 0.997 |
To mitigate the risk of inaccurate test results for hydrophobic drugs, the following statement has been added to the labeling:
"Hydrophobic drugs have been known to adsorb to the gel of gel separator tubes, which may result in lower measured drug concentrations. However, these effects depend on various factors including the chemical and physical properties of the drug, contact time with the gel, volume of the sample on the gel, storage temperature, and gel type. Users should consider these factors when evaluating the use of gel separator tubes for drug testing and monitoring. See Drug Adsorption in the References Section."
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
