BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.

BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).

Device Description

BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a glass tube and EDTA additive.

The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.

AI/ML Overview

The provided text describes the regulatory submission for BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI/human reader device with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, many of the requested details about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets in machine learning, expert adjudication, MRMC studies, standalone performance, and ground truth establishment in the context of AI are not applicable (N/A) to this document. This submission is for blood collection tubes, not a diagnostic algorithm.

However, I can extract information related to the performance testing of the blood collection tubes themselves.

Here's a breakdown of the relevant information from the document, with an emphasis on why certain requested fields are N/A:

1. A table of acceptance criteria and the reported device performance

Since this is for a medical device (blood collection tubes) and not an AI algorithm, the "acceptance criteria" are related to mechanical and physical performance, and clinical equivalence for blood parameters.

Test	Acceptance Criteria (Implied by "Pass" result and regulatory context)	Reported Device Performance
Draw Volume	Must meet defined specifications	Pass
X-Value (likely relates to vacuum pressure or fill volume)	Must meet defined specifications	Pass
Second Stopper Pullout	Must meet defined specifications for stopper integrity	Pass
Stopper/Shield Separation	Must meet defined specifications for closure integrity	Pass
Stopper Leakage	Must demonstrate no leakage	Pass
Resistance to Breakage during Drop Testing	Must withstand specified drop tests without breakage	Pass
Resistance to Breakage During Centrifugation	Must withstand specified centrifugal forces without breakage	Pass
Ship Testing for Functional Performance of Packaging Materials	Must maintain integrity and function after simulated shipping	Pass
Clinical Equivalence (Method Comparison)	Mean and 95% Confidence Limits of paired sample biases within Clinical Acceptance Limits (CALs) for key hematology parameters (WBC, RBC, RDW, Hgb, HCT, MCV, MCH, MCHC, Platelets, 5-part WBC differential)	Demonstrated for all parameters except Hgb, PLT, and WBC at low medically relevant points on two instruments (mean bias within CAL, but C.I. exceeded; deemed clinically acceptable due to insufficient low-point data)
Precision (Lot to Lot Variability)	Non-inferiority for repeatability (within tube) and reproducibility (lot-to-lot and tube-to-tube) when compared to a comparator device for tested hematology parameters	Non-inferiority shown for all tube comparisons and hematology parameters on two instrument platforms.
Within-Tube Type Stability	Analytes must demonstrate stability at specified storage conditions and time points (12- and 24-hours Room Temperature, 24 hours Refrigerated, 24 hours Room Temperature followed by 24 hours Refrigerated).	All analytes demonstrated stability.
Shelf-Life	Product must maintain performance over proposed shelf life	11 months for K2EDTA, 10 months for K3EDTA.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact number of samples or subjects for the clinical studies. It mentions "low medically relevant points were insufficient to adequately power the analysis" for Hgb, PLT, and WBC in the method comparison, suggesting a limitation in that specific subgroup analysis.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies involved "testing performed internally and externally," and "clinical samples." There is no mention of prospective or retrospective design, but clinical equivalence and stability studies typically involve prospective collection or use of fresh samples to assess performance over time/conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This device does not rely on expert interpretation for "ground truth" in the way an AI algorithm for image analysis would. The "truth" for blood parameters is established by laboratory analyzers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not relevant. This is not an image interpretation or diagnostic decision-making study that would 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

N/A. Not an AI-assisted human reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. Not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be the analytical results obtained from established, calibrated laboratory instruments (e.g., hematology analyzers) using the collected blood samples. Clinical equivalence was demonstrated against "legally marketed comparator tubes," implying that the comparator's performance on these instruments serves as the reference.

8. The sample size for the training set

N/A. This is not an AI/machine learning device. There are no training sets.

9. How the ground truth for the training set was established

N/A. Not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2023

Becton Dickinson and Company Katherine Lemus Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K213670

Trade/Device Name: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: GIM Dated: November 19, 2021 Received: November 22, 2021

Dear Katherine Lemus:

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 (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 located 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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Min Wu-S

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213670

Device Name

BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes

Indications for Use (Describe)

BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, contamment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY 1

1.1 Device Name

BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes

Summary Preparation Date: 1.2

Date: 5/21/2023

1.3 Submitted by:

Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885

Phone: (201) 847-6800

1.4 Contact:

Katherine Kenner Lemus, MS, RAC-US Senior Regulatory Affairs Specialist email: Katherine.Lemus@bd.com

Phone: (801) 541-9274 Work: (201) 847 6800

1.5 Alternate Contact:

Matthew Trachtenberg Director Regulatory Affairs email: Matthew.trachtenberg@bd.com

Phone: (201) 847-6337 Work: (201) 847-6800

1.6 Proprietary Names:

BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes

1.7 Common or Usual Names:

EDTA Blood Collection Tube

{4}------------------------------------------------

1.8 Regulatory Information:

Classification Name: Tubes, Vacuum Sample, With Anticoagulant Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Product Code: GIM

1.9 Predicate Device(s):

K981013 Vacutainer® Brand Plus Tube with EDTA Anticoagulant

1.10 Device Establishment

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, A1: 2013, A2 2018 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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 14971:2012 Medical Devices - Application of risk management to medical devices

{5}------------------------------------------------

1.13 Intended Use

BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW). hemoglobin (HzB). hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).

Device Description 1.14

1.15 Substantial Equivalence

The subject and predicate device are substantially equivalent as described in Table 2.

For the BD Vacutainer® K2EDTA Blood Collection Tubes, a reference device is included in this submission to support the inclusion of the K3EDTA additive.

{6}------------------------------------------------

Table 1: Substantial Equivalence Comparison

Characteristic	Subject DeviceBD Vacutainer® K2EDTA Blood CollectionTubes and BD Vacutainer® K3EDTA BloodCollection Tubes	Predicate DeviceVacutainer® Brand PlusTube with EDTAAnticoagulantK981013	Reference DeviceBD Vacutainer® K3EDTABlood Collection TubePre-Amendment Device	Comments
Indication for use	BD Vacutainer® EDTA Blood Collection Tubesare evacuated, sterile, single use, in vitrodiagnostic medical devices. They are intendedto be used by trained healthcare professionalsfor the collection, containment, preservation,and transport of human venous bloodspecimens used for in vitro diagnostic testing.BD Vacutainer® K2EDTA and K3EDTA BloodCollection Tubes are used for testing inhematology including white blood cells (WBC),red blood cells (RBC), red blood celldistribution width (RDW), hemoglobin (HgB),hematocrit (HCT), mean corpuscular volume(MCV), mean corpuscular hemoglobin (MCH),mean corpuscular hemoglobin concentration(MCHC), platelets, and 5-part white blood cell(WBC) differential counts (neutrophils,lymphocytes, monocytes, eosinophils,basophils).	The Vacutainer® Brand PLUS(plastic) Tube with EDTAanticoagulant and Vacutainer®Brand Serum Tube areevacuated blood collectiontubes which provide a meansof collecting, transportingseparating and processingblood in a plastic tube. Whenthe tube is used together withVacutainer® Brand Needlesand Holders, is a closedsystem for the collection ofvenous blood with the sameindications as describedherein.Blood collected in PLUSEDTA and PLUS Serum tubescan be used forimmunohematology testingincluding ABO grouping, Rhgrouping, and antibodyscreening which requires redcells and plasma or serum	BD Vacutainer® K3EDTABlood Collection Tubes areintended for the collection of aplasma specimen in a closedevacuated system. The tubemay be used for in vitrodiagnostic testing forchemistry and hematologydeterminations in plasma orwhole blood.	The proposed indication foruse is mostly equivalent to theindication cleared underK981013 with the exceptionof more explicitly stating usefor testing in hematology.The K981013 510(k)Summary similarly states thatthe predicate EDTA tubes "isused primarily for clinicallaboratory hematologystudies." The subject andpredicate devices have thesame intended use
Intended Use	Blood Collection for hematology	Blood Collection forhematology andImmunohematology	Blood Collection forchemistry and hematology	The subject intended use is thesame as the predicate intendeduse for hematology
IntendedPopulation	General Use – all populations	General Use – all populations	General Use – all populations	No change
Characteristic	Subject DeviceBD Vacutainer® K2EDTA Blood CollectionTubes and BD Vacutainer® K3EDTA BloodCollection Tubes	Predicate DeviceVacutainer® Brand PlusTube with EDTAAnticoagulantK981013	Reference DeviceBD Vacutainer® K3EDTABlood Collection TubePre-Amendment Device	Comments
Evacuated BloodCollection Tube	Yes	Yes	Yes	No change
Clot/Anti-coagulation	Anti-coagulation	Anti-coagulation	Anti-coagulation	No change
Additive Type	K2EDTA, K3EDTA	K2EDTA	K3EDTA	The subject device includestubes with both K2EDTA andK3EDTA additives. TheK2EDTA is the same additiveas the predicate device clearedunder K981013. The K3EDTAadditive is legally marketedper the referenced pre-amendment device. Theadditional additive does notraise new questions of safetyor effectiveness.
Additive Quantity	1.8 mg/mL (K2EDTA), 1.75 mg/mL (K3EDTA)	1.8 mg/mL	1.2-4 mg/mL	There is no change in theblood-to-additive ratio for theK2EDTA tube. The blood-to-additive ratio for the K3EDTAtube is within the range citedfor pre-amendment devices.This change does not result innew questions of safety oreffectiveness.
Tube Dimensions(mm)	13x75,13x100,16x100	13x75	13×100	The difference in size does notraise new questions of safetyor effectiveness.
Characteristic	Subject DeviceBD Vacutainer® K2EDTA Blood CollectionTubes and BD Vacutainer® K3EDTA BloodCollection Tubes	Predicate DeviceVacutainer® Brand PlusTube with EDTAAnticoagulantK981013	Reference DeviceBD Vacutainer® K3EDTABlood Collection TubePre-Amendment Device	Comments
Draw Volume	2, 3, 4, 6, 7, 10 mL	6 mL	2, 3, 3.5, 4, 5, 7, 10, 20 mL	The difference in drawvolume does not raise newquestions of safety oreffectiveness.
Tube Material	Plastic (K2EDTA), Glass (K3EDTA)	Plastic	Glass	No change
Tube Closure	Conventional or Hemogard™ Safety Closure	Conventional or Hemogard™Safety Closure	Conventional	No change
Stopper Fabrication	Compression Molded Rubber	Compression molded rubber	Compression molded Rubber	No change
Hemogard™ Shieldfabrication	Injection Molded Plastic	Injection Molded Plastic	N/A	No change
Additive Dispense	Spray Dry (K2EDTA), Liquid Fill (K3EDTA)	Spray Dry (K2EDTA)	Liquid Fill (K3EDTA)	No change
Tube Evacuation	Vacuum Chamber	Vacuum Chamber	Vacuum Chamber	No change
Unit Labeling	Printed paper label	Printed paper label orimprinted on tube	Printed paper label	Changing from paper labeland imprinted label options topaper label only does not raisenew questions of safety oreffectiveness.
SterilizationMethod	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	No change
Sterility AssuranceLevel (SAL)	≤ 10-3	≤ 10-3	≤ 10-3	No change
Shelf Life	11 Months (K2EDTA), 10 Months (K3EDTA)	15-24 months	12 months	Shelf-life dates are based ontest data currently availablefor subject devices.Differences in shelf-life do notraise new questions of safetyor effectiveness.
Characteristic	Subject DeviceBD Vacutainer® K2EDTA Blood CollectionTubes and BD Vacutainer® K3EDTA BloodCollection Tubes	Predicate DeviceVacutainer® Brand PlusTube with EDTAAnticoagulantK981013	Reference DeviceBD Vacutainer® K3EDTABlood Collection TubePre-Amendment Device	Comments
Packaging	Unit – tube and closureShelf – shrink wrapped polystyrene trayCase - corrugated cardboard	Unit – tube and closureShelf – shrink wrappedpolystyrene trayCase - corrugated cardboard	Unit – tube and closureShelf – shrink wrappedpolystyrene trayCase - corrugated cardboard	No change

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

1.16 Performance Testing - Bench Summarv

Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® EDTA Blood Collection Tubes at time-zero and over the proposed shelf life:

Test	Result
Draw Volume	Pass
X-Value	Pass
Second Stopper Pullout	Pass
Stopper/Shield Separation	Pass
Stopper Leakage	Pass
Resistance to Breakage during Drop Testing	Pass
Resistance to Breakage During Centrifugation	Pass
Ship Testing for Functional Performance of Packaging Materials	Pass

The BD Vacutainer® EDTA 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 that the modifications to the device do not impact its safety or effectiveness and that the subject BD Vacutainer® EDTA Blood Collection Tubes continue to perform as intended.

1.17 Performance Testing - Animal Summary

No animal studies were performed in support of this submission.

1.18 Performance Testing - Clinical Summarv

The suitability of the BD Vacutainer® EDTA Blood Collection Tubes for collection of clinical samples was demonstrated through testing performed internally and externally which demonstrated clinical equivalency to the venous comparator tube by performing the following studies: Method Comparison (Clinical Equivalence), Precision, Within-Tube Type Stability, and Shelf Life. Testing was performed on identified analytes (i.e., White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin, Hematocrit, Platelet Count, Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, Basophil %, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Mean Corpuscular Volume, and Red Cell Distribution Width."

Method Comparison

This study was performed to evaluate Clinical Equivalence between the evaluate the performance of BD Vacutainer® EDTA Blood Collection Tubes against legally marketed comparator tubes., for the analytes identified above. This assessment considered whether the

{11}------------------------------------------------

mean and the two one-sided 95% Confidence Limits of the paired sample biases were within the Clinical Acceptance Limits (CALs).

Clinical equivalency was demonstrated for all hematology parameters for each tube comparison except Hgb, PLT, and WBC at the low medically relevant points on two instruments. For these three analytes the mean bias was within the predefined clinical acceptance limits, but exceeded the confidence interval. The observed non-equivalence is clinically acceptable, as the number of data points at the low medically relevant points were insufficient to adequately power the analysis.

Lot to Lot Variability

This study was performed to evaluate non-inferiority of the BD Vacutainer® K2EDTA tube for repeatability (within tube) and reproducibility (lot-to-lot and tube-to-tube) variation using hematology parameters identified above.

Performance of the BD Vacutainer® K2EDTA Tubes with Hemogard™ closure for repeatability. lot-to-lot variation and tube-to-tube variation showed non-inferiority for all tube comparisons for the hematology parameters tested on two instrument platforms when compared with a comparator device.

Within-Tube Type Stability

This study evaluated within-tube type stability of BD Vacutainer® EDTA Blood Collection Tubes by comparing samples taken from the same subject in the candidate tubes at various identified time points and storage conditions.

All analytes demonstrated stability at 12- and 24-hours storage Room Temperature, 24 hours Refrigerated, 24 hours Room Temperature followed by 24 hours Refrigerated.

Shelf-Life

The purpose of this study was to evaluate product shelf-life by evaluating evaluate Shelf-Life performance (11+1 months or 10+1 months from date of manufacture) of BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes with Hemogard™ closure and Conventional closure, respectively, in comparison with recently manufactured BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes for selected hematology test parameters.

Real time clinical stability testing performed using clinical samples demonstrated a shelf life of 11 months for BD Vacutainer® K2EDTA Blood Collection Tubes and 10 months for BD Vacutainer® K3EDTA Blood Collection Tubes.

1.19 Conclusion

The technical performance characteristics of the subject device are unchanged. The proposed BD Vacutainer® EDTA Blood Collection Tubes and predicate device of the same name have the same intended use, principle of operation, and technological characteristics. Non-Clinical and Clinical Performance Testing support the determination that the changes made to the

{12}------------------------------------------------

BD Vacutainer® EDTA Blood Collection Tubes do not raise any new concerns of safety or effectiveness. Based on information provided in this submission the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.