(266 days)
BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices available with Sodium Fluoride/Potassium Oxalate or Sodium Fluoride/Na2EDTA. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and centrifugation of venous blood specimens as required for in vitro diagnostic testing. Plastic BD Vacutainer® Fluoride Blood Collection Tubes are used to collect whole blood for the generation of plasma samples.
Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium FluoridePotassium Oxalate are used for glucose and lactate determinations. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Na2EDTA are used for glucose determinations.
The BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, Class II in vitro diagnostic medical devices regulated under 21 CFR § 862.1675 for blood specimen collection devices, and product code GIM for tubes, vacuum sample, with anticoagulant. The tubes are intended to be used in settings where venous blood samples would be collected by trained healthcare professionals for the collection, containment, preservation, transportation, and centrifugation of blood in a closed tube.
BD Vacutainer® Fluoride Blood Collection Tubes are available in a plastic configuration containing various additive combinations in a blended powder mixture. The blended powder mixture contains sodium fluoride, which acts as an antiglycolytic agent. The plastic tube configurations also include various additives which provide an anticoagulated specimen when used according to the instructions for use. Tubes include a Gray color-coded BD Hemogard™ Closure indicative of the Fluoride additive. Tube stoppers are lubricated with silicone to facilitate stopper insertion.
The provided text describes the regulatory submission for the BD Vacutainer® Fluoride Blood Collection Tubes, a Class II medical device. The focus of the document is on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific performance criteria through a detailed clinical study with AI.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not directly applicable or explicitly stated in this document. This submission is for a blood collection tube, which is a physical device, and the "performance testing" described refers to bench and clinical studies on its ability to collect, preserve, and allow for accurate measurement of analytes (glucose, lactate). It does not involve an AI/ML component.
Based on the provided text, here's an attempt to answer the questions to the extent possible, highlighting where the information is not present due to the nature of the device (a blood collection tube, not an AI/ML system):
1. A table of acceptance criteria and the reported device performance
The document mentions that "Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria" and that "Clinical testing results based on pre-determined acceptance criteria confirmed the functional clinical equivalence and performance." However, the specific numerical acceptance criteria and the quantitative reported device performance values are not provided in this summary. Instead, it states that the device "met all non-clinical testing requirements at time-zero and over the product shelf life" and confirmed "functional clinical equivalence and performance."
Therefore, a table cannot be constructed with the detailed information requested.
2. Sample size used for the test set and the data provenance
The document broadly states "Clinical testing was conducted on blood collected in the subject devices (BD Vacutainer® Fluoride Blood Collection Tubes) and a legally marketed comparator device." It does not specify the sample size for clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided. The "ground truth" for this device would relate to accurate glucose and lactate measurements, which are established by standard laboratory analytical methods, not by human expert interpretation in the way it would be for an AI diagnostic imaging device.
4. Adjudication method for the test set
Not applicable and not provided. Data from analytical measurements do not typically require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor does it involve human readers in the context of diagnostic interpretation that would benefit from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a blood collection tube, not an algorithm.
7. The type of ground truth used
For glucose and lactate determinations, the ground truth would be established by reference analytical methods performed on the blood samples, typically using laboratory analyzers considered the gold standard for those measurements. The document implies this by stating the tubes are used "for glucose and lactate determinations" and that clinical testing confirmed "functional clinical equivalence and performance... in the identification of clinically relevant levels of glucose and lactate."
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this device does not use a "training set" in the AI/ML context.
Summary of what is present in the document relevant to device acceptance/performance (though not in the AI/ML context):
- Device: BD Vacutainer® Fluoride Blood Collection Tubes (physical blood collection device).
- Purpose: Collection, containment, preservation, transportation, and centrifugation of venous blood specimens for in vitro diagnostic testing, specifically for glucose and lactate determinations.
- Performance Testing:
- Non-clinical (Bench): Evaluation of attributes such as Draw Volume, X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Breakage Resistance During Centrifugation, and Breakage Resistance During Drop Testing. Also, Ship Testing for packaging.
- Clinical: Comparative testing against a legally marketed comparator device to demonstrate clinical equivalence in glucose and lactate determinations. Also, Within-Tube Stability, Shelf-Life Performance, and Repeatability/Reproducibility.
- Results: All non-clinical and clinical testing requirements were met, demonstrating the device functions as designed and is clinically equivalent.
- Acceptance Criteria Details: Not provided publicly in this summary. The document states "defined protocols and with established acceptance criteria" were used, but the specifics are confidential.
- Ground Truth (for glucose/lactate): Implied to be established by standard laboratory analytical methods for glucose and lactate measurements.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 19, 2024
Becton, Dickinson and Company Angela Mariani Senior Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K231237
Trade/Device Name: BD Vacutainer® Fluoride Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, GIM Dated: December 21, 2023 Received: December 21, 2023
Dear Angela Mariani:
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).
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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 mediation-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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division 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) K231237
Device Name
BD Vacutainer® Fluoride Blood Collection Tubes
Indications for Use (Describe)
BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices available with Sodium Fluoride/Potassium Oxalate or Sodium Fluoride/Na2EDTA. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and centrifugation of venous blood specimens as required for in vitro diagnostic testing. Plastic BD Vacutainer® Fluoride Blood Collection Tubes are used to collect whole blood for the generation of plasma samples.
Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium FluoridePotassium Oxalate are used for glucose and lactate determinations. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Na2EDTA are used for glucose determinations.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K231237
1.1 Device Name
BD Vacutainer® Fluoride Blood Collection Tubes
1.2 Summary Preparation Date:
January 19, 2024
1.3 Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
1.4 Contact:
Angela Mariani Senior Regulatory Affairs Manager email: Angela.Mariani(@)Bd.com
Phone: (860) 508-4352
1.5 Alternate Contact:
Matthew Trachtenberg Director of Regulatory Affairs email: Matthew Trachtenberg@Bd.com
Phone: (201) 847-6337
Proprietary Names: 1.6
BD Vacutainer® Fluoride Blood Collection Tubes
1.7 Common or Usual Names:
Tubes, Vacuum Sample, With Anticoagulant
Regulatory Information 1.8
Classification Name: Tubes, Vacuum Sample, With Anticoagulant Classification Regulation: 21 CFR § 862.1675
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Regulatory Class: Class II Product Code: GIM/JKA
1.9 Predicate Device
BD Vacutainer® Plus Blood Collection Tubes containing Potassium Oxalate / Sodium Fluoride (K901449)
Device Establishment 1.10
Becton, Dickinson and Company
1.11 Registration Number:
2243072
Performance Standards: 1.12
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Svstems
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 2013-06-01Sterilization 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 microrganisms 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
1.13 Intended Use
BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices available with Sodium Fluoride/Potassium Oxalate or Sodium Fluoride/Na2EDTA. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, transportation, and centrifugation of venous blood
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specimens as required for in vitro diagnostic testing. Plastic BD Vacutainer® Fluoride Blood Collection Tubes are used to collect whole blood for the generation of plasma samples.
Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Potassium Oxalate are used for glucose and lactate determinations. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Na>EDTA are used for glucose determinations.
1.14 Device Description
The BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, Class II in vitro diagnostic medical devices regulated under 21 CFR § 862.1675 for blood specimen collection devices, and product code GIM for tubes, vacuum sample, with anticoagulant. The tubes are intended to be used in settings where venous blood samples would be collected by trained healthcare professionals for the collection, containment, preservation, transportation, and centrifugation of blood in a closed tube.
BD Vacutainer® Fluoride Blood Collection Tubes are available in a plastic configuration containing various additive combinations in a blended powder mixture. The blended powder mixture contains sodium fluoride, which acts as an antiglycolytic agent. The plastic tube configurations also include various additives which provide an anticoagulated specimen when used according to the instructions for use. Tubes include a Gray color-coded BD Hemogard™ Closure indicative of the Fluoride additive. Tube stoppers are lubricated with silicone to facilitate stopper insertion.
Substantial Equivalence 1.15
The subject and predicate device are substantially equivalent as described in Table 1.
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| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| Characteristic | Subject Device:BD Vacutainer® Fluoride Blood Collection Tubes | Predicate Device:BD Vacutainer® Plus Blood CollectionTubes containing Potassium Oxalate /Sodium Fluoride (K901449) | Comparison |
|---|---|---|---|
| Indications for Use | BD Vacutainer® Fluoride Blood Collection Tubes areevacuated, sterile, single use, in vitro diagnostic medicaldevices available with Sodium Fluoride/Potassium Oxalateor Sodium Fluoride/Na2EDTA. They are intended to be usedby trained healthcare professionals for the collection,containment, preservation, transportation, and centrifugationof venous blood specimens as required for in vitrodiagnostic testing. Plastic BD Vacutainer® Fluoride BloodCollection Tubes are used to collect whole blood for thegeneration of plasma samples.Blood collected in BD Vacutainer® Fluoride BloodCollection Tubes containing Sodium Fluoride/PotassiumOxalate are used for glucose and lactate determinations.Blood collected in BD Vacutainer® Fluoride BloodCollection Tubes containing Sodium Fluoride/Na2EDTA areused for glucose determinations. | The BD Vacutainer® Fluoride Tubes areintended to provide a means of collecting,transporting, separating, and processingblood in a closed tube. | The intended use of the subject device is the sameas the predicate with regard to the claims forcollection, transportation, and separating(centrifugation) of blood for in vitro diagnostic use,with the subject device's Indications for Useproviding additional clarity on certain informationconsistent with current best practices. The additionof a specific reference to lactate is not considered anew intended use because the subject and predicatedevices are both intended for determination ofanalytes in the blood that are stabilized by theglycolytic inhibition associated with the Fluorideadditive present in the tubes. |
| Intended Population | General Use - all populations | General Use - all populations | Identical |
| Evacuated BloodCollection Tube | Yes | Yes | Identical |
| Characteristic | Subject Device:BD Vacutainer® Fluoride Blood Collection Tubes | Predicate Device:BD Vacutainer® Plus Blood CollectionTubes containing Potassium Oxalate /Sodium Fluoride (K901449) | Comparison |
| Tube Dimensions,Material, and DrawVolume | BD Vacutainer® Sodium Fluoride / Potassium OxalateTubes:13 x 75 mm, plastic, 2.0 mL13 x 75 mm, plastic, 4.0 mL13 x 100 mm, plastic, 6.0 mLBD Vacutainer® Sodium Fluoride / Na2EDTA Tube:13 x 75 mm, plastic, 2.0 mL | BD Vacutainer® Sodium Fluoride /Potassium Oxalate Tubes:13 x 75 mm, plastic, 2.0 mL | The additional options for tube dimensions anddraw volume do not raise different questions ofsafety and effectiveness as described below. |
| Sample Type | Plasma | Whole BloodPlasma | Identical |
| Additive Type,Application, andConcentration | Sodium Fluoride / Potassium Oxalate:2.5 mg/mL / 2mg/mL, powderSodium Fluoride / Na2EDTA:1.5 mg/mL / 3 mg/mL, powder | Sodium Fluoride / Potassium Oxalate:2.5 mg/mL / 2mg/mL, powder | The additional additive configuration does not raisedifferent questions of safety and effectiveness asdescribed below. |
| Tube Closure/Color | BD Hemogard™ / Gray | BD Hemogard™ / Gray | Identical |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility AssuranceLevel (SAL) | 10-3 | 10-3 | Identical |
| Shelf Life | Varies by configuration | 12 months | The shelf life is established based on availableshelf-life testing so difference in shelf-life do notraise different questions of safety and effectiveness. |
| Characteristic | Subject Device:BD Vacutainer® Fluoride Blood Collection Tubes | Predicate Device:BD Vacutainer® Plus Blood Collection Tubes containing Potassium Oxalate / Sodium Fluoride (K901449) | Comparison |
| Packaging | Tray: 100 tubesCase: 1000 tubes (10x100) | Tray: 100 tubesCase: 1000 tubes (10x100) | Identical |
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1.16 Substantial Equivalence Discussion
Intended Use
The intended use of the subject device is the same as the predicate with regard to the claims for collection, transportation, and separating (centrifugation) of blood for in vitro diagnostic use. The subject device's Indications for Use provide additional clarity on the specimen type: venous whole blood collection for the generation of plasma. These clarifying statements do not alter the intended use of the device.
The subject device's Indications for Use statement makes reference to glucose and lactate determinations. while the predicate's Indications for Use statement only references the determination of glucose. The intended use for the subject and predicate devices are the same because both are intended for determination of analytes in the blood that are stabilized by the glycolytic inhibition associated with the Fluoride additive present in both tubes. Both the subject and predicate devices include an anticoagulant that can produce either a whole blood sample, or following centrifugation, a plasma sample.
The additional analyte determinations and sample matrices listed in the Indications for Use have been fully validated through clinical testing as compared to currently marketed comparator devices.
Therefore, the subject and predicate devices have the same intended use.
Technological Characteristics
Both the subject and predicate tubes have similar technological characteristics. They are evacuated, sterile, single use, in vitro diagnostic medical devices with Gray BD Hemogard™ closures. There is no change in sterilization method or sterility assurance level for these tubes. Since the clearance of the predicate K901449, there were additional minor changes. Changes broadly included minimal changes to the Indications for Use statement which does not constitute a new intended use, nor impact the overall diagnostic effect for the claimed uses; and updates to the shelf life based on test data currently available which does not raise different questions of safety or effectiveness. Differences between the subject and justification why such differences do not raise different questions of safety and effectiveness are described below:
Draw Volume: Regarding differences in tube draw volumes (and the associated tube dimensions necessary to accommodate higher draw volumes), evaluation of an appropriate vacuum in the tube to meet the labeled draw volume, and to clinical studies to confirm appropriate blood to additive ratios are not new, and so do not result in different questions of safety and effectiveness.
Additive: Regarding the new Sodium Fluoride / Na2EDTA tube configuration, there is an EDTAbased anticoagulant instead of an Oxalate-based anticoagulant in the subject device. Evaluation that the anticoagulant can provide a whole blood or plasma sample, and that it provides acceptable clinical results are not different questions of safety or effectiveness.
Shelf Life: Regarding the varied shelf life, the shelf life is established based on available shelflife testing so difference in shelf-life do not raise different questions of safety and effectiveness.
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Testing was completed on the subject device and demonstrated that the product requirements were met.
Performance Testing - Bench Summary 1.17
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Fluoride Blood Collection Tubes at time-zero and over the proposed shelf life: Draw Volume. X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Breakage Resistance During Centrifugation, and Breakage Resistance During Drop Testing. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials.
The BD Vacutainer® Fluoride Blood Collection Tubes met all non-clinical testing requirements at time-zero and over the product shelf life, demonstrating that the device functions as designed. These performance tests demonstrate substantial equivalence of the subject device to the predicate device.
1.18 Performance Testing - Animal Summarv
No animal studies were performed in support of this submission.
1.19 Performance Testing - Clinical Summarv
Clinical testing was conducted on blood collected in the subject devices (BD Vacutainer® Fluoride 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 based on pre-determined acceptance criteria confirmed the functional clinical equivalence and performance of the BD Vacutainer® Fluoride Blood Collection Tubes in the identification of clinically relevant levels of glucose and lactate.
1.20 Conclusion
The proposed BD Vacutainer® Fluoride Blood Collection Tubes and predicate device have the same intended use, and any technological characteristics that differ from the predicate have been evaluated to demonstrate they do not result in different questions of safety and effectiveness. Non-Clinical and Clinical Performance Testing sufficiently support the determination of substantial equivalence of the BD Vacutainer® Fluoride Blood Collection Tubes. Based on information provided in this submission, the subject device is substantially equivalent to the predicate device.
§ 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.