(267 days)
Not Found
No
The device is a blood collection tube and the description and performance studies focus on its physical and chemical properties, not on any computational or analytical capabilities. There is no mention of AI or ML in the document.
No
The device is a blood collection tube used for in vitro diagnostic testing to obtain and store serum for clinical laboratory testing. It is not used for treatment or therapy.
No
This device is a blood collection tube used to prepare samples for in vitro diagnostic testing, but it does not perform the diagnostic test itself.
No
The device description clearly outlines physical components including a plastic tube, cap assembly, separator gel, and clot activator. This indicates it is a hardware device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the device is used "for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing." This directly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes are sterile blood collection tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Serum Separator (SST™) Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant. 3) an inert polymer separator gel, and 4) a clot activator.
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
It is used in settings where a venous blood specimen is collected by a trained healthcare professional.
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)
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Serum Separator (SSTTM) Blood Collection Tubes at time-zero and over the claimed shelf life: Draw Volume, X-Value, 2nd Stopper Pullout, Stopper/Shield Separation, Stopper Leakage (or blood pooling), Tube Leakage, Resistance to Breakage During Drop Testing, Resistance to Breakage During Centrifugation, Barrier Formation following Centrifugation, and Barrier Integrity following Simulated Transport. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials. All bench testing was completed on final, finished devices and conducted on a minimum of three unique lots of product to assess potential sources of lot-to-lot variability. Each test was also completed on a subset of product sterilized in excess of the maximum specified irradiation dosage. Testing over shelf life was conducted over 11-16 months of accelerated aging, during which the devices were subjected to storage at 40°C and 50% Relative Humidity (RH) to accelerate the aging process according to the Arrhenius equation, and over 11-13 months of real time aging, during which the devices were subjected to storage at 25°C and 50% RH. Test intervals were selected as at least 11 months of accelerated aging for SST™ products with a 10 month shelf life; and at least 13 months for SST™ products with a 12 month shelf life. Real time aging studies were completed to confirm all accelerated aging data, and both sets of aging results met the predetermined acceptance criteria.
Clinical testing was conducted on whole blood collected in the subject device BD Vacutainer® Serum Separator (SSTTM) Blood Collection Tubes and a legally marketed comparator device to demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-Tube Stability, Shelf-Life Performance, and Repeatability / Reproducibility, Clinical testing results confirmed the devices' clinical equivalence for chemistry analytes and in therapeutic drug monitoring (TDM) using these tubes. A summary of the clinical studies completed is included below:
- Clinical Equivalence and Within-Tube Stability: The purpose of these studies was to evaluate the Clinical Equivalence of multiple BD Vacutainer® Serum Separator Blood Collection Tubes (BD SST™) in comparison with a similarly marketed serum separator tube and demonstrate Within Tube Stability (WTS) for select routine and. special chemistry analytes, therapeutic drugs, and select cardiac markers. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use.
- Repeatability/Reproducibility: These studies evaluated the clinical performance of BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes in comparison with a similarly marketed serum separator tube for selected chemistry analytes and therapeutic drugs for repeatability (within tube) by testing each tube in duplicate, as well as lot-to-lot reproducibility and tube-to-tube reproducibility by testing two tubes per lot per subject across 3 lots on two different instrument platforms. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use.
- Shelf-Life: This study evaluated the performance of BD Vacutainer® Serum Separator Tubes (BD SST™) at the end of shelf life (EOSL) in comparison with BD SST™ Tubes that were recently manufactured for selected chemistry analytes and therapeutic drugs. Three lots for each SKU of EOSL tubes were evaluated in this study. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use.
Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® Serum Separator (SST™) Blood Collection Tube are suitable for use evaluating chemistry analytes and in therapeutic drug monitoring (TDM) testing.
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.
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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2023
Becton Dickinson and Company Matthew Tennen Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K230855
Trade/Device Name: BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: November 16, 2023 Received: November 17, 2023
Dear Matthew Tennen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Lindsey M. Coe -S
for Paula Caposino, PhD Acting Division Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230855
Device Name
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
Indications for Use (Describe)
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY K230855 5
5.1 Device Name
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
5.2 Summary Preparation Date:
Date: November 13, 2023
5.3 Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
5.4 Contact:
Matthew B. Tennen Senior Regulatory Affairs Specialist email: Matthew.B.Tennen@bd.com
Phone: (201) 847-7392 Work: (201) 847-6800
Alternate Contact: ર્સ્ટ
Matthew Trachtenberg Director Regulatory Affairs email: Matthew.Trachtenberg@bd.com
Phone: (201) 847-6337 Work: (201) 847-6800
5.6 Proprietary Name:
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
5.7 Common or Usual Names:
Serum Separator Blood Collection Tube
Regulatory Information 5.8
Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Classification Regulation: 21 CFR § 862.1675
Regulatory Class: Class II Product Code: JKA
4
5.9 Predicate Device
BD Vacutainer® PLUS SST™ Tube (K023075)
5.10 Device Establishment
Becton, Dickinson and Company
5.11 Registration Number:
2243072
5.12 Performance Standards:
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
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: 2013 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"
EN ISO 14971:2019 Medical Devices – Application of risk management to medical devices
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5.13 Intended 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 Description 5.14
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes are sterile blood collection tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Serum Separator (SST™) Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant. 3) an inert polymer separator gel, and 4) a clot activator.
6
Substantial Equivalence 5.15
The subject and predicate device are substantially equivalent as described in Table 1.
| Characteristic | Subject Device - BD
Vacutainer® Serum
Separator (SSTTM) Blood
Collection Tube | Predicate Device - BD
Vacutainer® SST Plus
Tubes (K023075) | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BD Vacutainer® Serum
Separator (SSTTM) 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. | The Vacutainer™ PLUS
SST™ Tube is a plastic
evacuated blood collection
tube with silica clot
activator and gel that
provides a means of
collecting, transporting,
separating, and processing
blood in a closed tube.
Blood collected in a
Vacutainer™ PLUS SST
Tube is primarily used for
clinical laboratory testing in
chemistry using patient
serum but may be used for
other assays requiring serum
specimens as determined by
the laboratory. In addition,
the Vacutainer™ PLUS
SST™ Tube is compatible
with many commonly used
therapeutic drugs therefore
suitable for therapeutic drug
monitoring (TDM). Blood
can be collected, processed,
and stored in a Vacutainer™
PLUS SST™ tube for at
least 24 hours for
therapeutic drug monitoring
without large losses in
recovery | There are minor
changes to the
indications for
use wording to
best align with
the appropriate
use of the
product and
available testing.
The closed tube
reference was
removed as the
processing and
testing of the
samples within
the tube is
dependent on the
laboratory
testing being
performed.
These changes
do not result in a
new intended use
for the subject
device. |
| Intended Population | General Use | General Use | Identical |
| Evacuated Blood
Collection Tube | Yes | Yes | Identical |
| Tube Dimension | 13 x 75 mm,
13 x 100 mm,
16 x 100 mm
16 x 125 mm | 13 x 75 mm,
13 x 100 mm,
16 x 100 mm
16 x 125 mm | Identical |
| Tube Draw volumes | 3.5mL, 4.0mL, 5.0mL, 7.5mL,
8.5mL, and 10mL | 3.5mL, 4.0mL, 5.0mL,
7.5mL, 8.5mL, and 10mL | Identical |
| Sample Type | Serum | Serum | Identical |
| Additive Type | BD Vacutainer® Serum
Separator (SSTTM):
Silica clot activator | BD Vacutainer® Serum
Separator (SSTTM):
Silica clot activator | Identical |
| Additive
Application/Quantity | Clot Activator Spray Dried
Clot Activator amounts range
from 2.1-4.3 mg/mL. | Clot Activator Spray Dried
Clot Activator amounts
range from 2.1-4.3 mg/mL. | Identical |
| Tube Material | PET (polyethylene
terephthalate) plastic | PET (polyethylene
terephthalate) plastic | Identical |
| Tube Closure | BD HemogardTM / Gold cap
with red stopper
Conventional stopper:
Red/Grey | BD HemogardTM / Gold cap
with red stopper
Conventional stopper:
Red/Grey | Identical |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility Assurance Level
(SAL) | 13x75mm HemogardTM/ 10-3
13x100mm HemogardTM/ 10-3
or 10-6
16x100mm Conventional/ 10-3
16x125mm Conventional/ 10-3 | 13x75mm HemogardTM/ 10-3
13x100mm HemogardTM/ 10-3
16x100mm Conventional/ 10-3
16x125mm Conventional/ 10-3 | BD sterilizes the
tubes at 10-3 or
10-6 based on
size and
configuration.
Sterilization of
some products at
a different SAL
does not raise
any new
questions of
safety or
effectiveness. |
| Shelf Life | 10 to 12 months | 12 months | Shelf-life
durations are
based on aged
test data
currently
available. The
tubes have
demonstrated
they maintain
appropriate
functionality
over the stated
shelf life. This
difference does
not raise new
questions of
safety or
effectiveness. |
| Packaging | Unit - tube and closure
Shelf – shrink wrapped
polystyrene tray | Unit - tube and closure
Shelf – shrink wrapped
polystyrene tray | Identical |
| | Case – corrugated cardboard | Case – corrugated cardboard | |
Table 1:Substantial Equivalence Comparison
7
8
5.16 Substantial Equivalence Discussion
Intended Use/Indications for Use
The indications for use of the subject BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes is considered the same as the previously cleared indications for use of the BD Vacutainer® Serum Separator (SST™) Blood Collection Tube under K023075. They are both intended to be used for the collection, transportation, separating, and processing blood in a tube for the testing of chemical analytes and for the monitoring of certain therapeutic drugs.
Any wording differences are intended to be a minor update to better clarify the products supported by the testing and possible uses in the laboratory setting. These minor changes do not result in a new intended use of the subject device.
Both the subject and predicate device have the same intended use and substantially similar indications for use, meeting the first criteria for a finding of substantial equivalence.
Technological Characteristics
Both the subject and predicate tubes have identical technological characteristics. They are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices with either gold BD Hemogard™ cap assemblies or Conventional stoppers with red/grey striping. While there have not been a significant number of technological changes, there have been two identifiable changes to the BD SSTTM tubes. The first change was a change in the sterility assurance level for one of the tubes. The change in the sterilization assurance level (SAL) to 10 € coincides with additional markets where the product is sold. The second change is relating to the shelf-life of the BD SST™ tubes. Depending on the configuration of the tube, the shelf life can be 10 months for (1 sku 13mm x 100mm) or 12 months (rest of the skus), whereas previously in 510(k), K023075, all tubes had a 12-month shelf life. Since the clearance of the predicate K023075, there were additional minor changes that individually did not require a new 510(k) submission nor introduce new/modified existing risks, but which have been determined to cumulatively warrant submission of this new 510(k). Changes broadly included label/packaging updates, qualification of additional material suppliers, material discontinuation/replacement/location changes, new/changed manufacturing sites/equipment/processing, minor specification updates, supplier changes, etc. These changes while different from the predicate submission do not raise new questions of safety or effectiveness and testing has demonstrated no impact to product performance.
5.17 Performance Testing - Bench Summary
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Serum Separator (SSTTM) Blood Collection Tubes at time-zero and over the claimed shelf life: Draw Volume, X-Value, 2nd Stopper Pullout, Stopper/Shield Separation, Stopper Leakage (or blood
9
pooling), Tube Leakage, Resistance to Breakage During Drop Testing, Resistance to Breakage During Centrifugation, Barrier Formation following Centrifugation, and Barrier Integrity following Simulated Transport. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials.
All bench testing was completed on final, finished devices and conducted on a minimum of three unique lots of product to assess potential sources of lot-to-lot variability. Each test was also completed on a subset of product sterilized in excess of the maximum specified irradiation dosage. Testing over shelf life was conducted over 11-16 months of accelerated aging, during which the devices were subjected to storage at 40°C and 50% Relative Humidity (RH) to accelerate the aging process according to the Arrhenius equation, and over 11-13 months of real time aging, during which the devices were subjected to storage at 25°C and 50% RH. Test intervals were selected as at least 11 months of accelerated aging for SST™ products with a 10 month shelf life; and at least 13 months for SST™ products with a 12 month shelf life. Real time aging studies were completed to confirm all accelerated aging data, and both sets of aging results met the predetermined acceptance criteria.
5.18 Performance Testing - Clinical Summary
Clinical testing was conducted on whole blood collected in the subject device BD Vacutainer® Serum Separator (SSTTM) Blood Collection Tubes and a legally marketed comparator device to demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-Tube Stability, Shelf-Life Performance, and Repeatability / Reproducibility, Clinical testing results confirmed the devices' clinical equivalence for chemistry analytes and in therapeutic drug monitoring (TDM) using these tubes. A summary of the clinical studies completed is included below:
- . Clinical Equivalence and Within-Tube Stability: The purpose of these studies was to evaluate the Clinical Equivalence of multiple BD Vacutainer® Serum Separator Blood Collection Tubes (BD SST™) in comparison with a similarly marketed serum separator tube and demonstrate Within Tube Stability (WTS) for select routine and special chemistry analytes, therapeutic drugs, and select cardiac markers. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use.
- . Repeatability/Reproducibility: These studies evaluated the clinical performance of BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes in comparison with a similarly marketed serum separator tube for selected chemistry analytes and therapeutic drugs for repeatability (within tube) by testing each tube in duplicate, as well as lot-to-lot reproducibility and tube-to-tube reproducibility by testing two tubes per lot per subject across 3 lots on two different instrument platforms. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use.
- Shelf-Life: This study evaluated the performance of BD Vacutainer® Serum Separator Tubes (BD SST™) at the end of shelf life (EOSL) in comparison with BD SST™ Tubes that were recently manufactured for selected chemistry analytes and therapeutic drugs. Three lots for
10
each SKU of EOSL tubes were evaluated in this study. Results were analyzed and found to be clinically acceptable when used under the conditions described in the Instructions for Use
Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® Serum Separator (SST™) Blood Collection Tube are suitable for use evaluating chemistry analytes and in therapeutic drug monitoring (TDM) testing.
5.19 Conclusion
The proposed BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes and predicate devices have the same intended use, principle of operation, and technological characteristics. Non-Clinical and Clinical Performance Testing sufficiently support the determination of substantial equivalence of the BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes. Based on information provided in this submission the proposed device is substantially equivalent to the predicate device.