BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube

Q: Who is the manufacturer of BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube?

Becton, Dickinson and Company filed the 510(k) submission for BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube (K230391).

Q: What is the FDA product code for BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K230391 · Becton, Dickinson and Company · JKA · Dec 1, 2023 · Clinical Chemistry

Device Facts

Record ID	K230391
Device Name	BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube
Applicant	Becton, Dickinson and Company
Product Code	JKA · Clinical Chemistry
Decision Date	Dec 1, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG). BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.

Device Story

System collects, separates, transports, and stores capillary blood samples; used in ancillary healthcare, clinical, and laboratory environments by trained healthcare workers (phlebotomists, pharmacists, technicians). Input: capillary blood (435–635 µL) via fingerstick. Process: Finger Sizing Tool selects sleeve; BD Microtainer® Contact-Activated Lancet punctures finger; blood collected into MiniDraw™ SST™ Tube; tube inverted 5 times; clotted at room temperature (45 mins); centrifuged (4000 RCF, 2.25 mins) in cap-down orientation. Tube contains silica-based clot activator and gel separator. Output: serum sample for downstream clinical chemistry analysis. Benefits: enables capillary blood collection in non-traditional settings; provides stable serum for specific analytes.

Clinical Evidence

No clinical diagnostic studies performed. Evidence consists of analytical bench testing and method comparison studies. Precision/reproducibility evaluated across 3 lots and 2 instrument platforms (N=138 and N=79 subjects). Operator variability assessed with 263 participants. Method comparison against predicate (K991702) and reference (K081929) performed at 5 sites using Passing Bablok/Deming regression; results showed high correlation (r > 0.97) and acceptable bias for all 14 analytes. Stability testing confirmed 9-month shelf life and 4-hour room temperature/48-hour refrigerated analyte stability.

Technological Characteristics

Materials: Polypropylene tube, TPE/polypropylene cap. Additives: Silica-based clot activator, gel separator. Principle: Capillary blood collection, gel-barrier serum separation via centrifugation. Dimensions: 435–635 µL capacity. Connectivity: None. Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for collection, separation, transport, and storage of capillary blood samples from individuals 18 years and older for measurement of specific chemistry analytes (ALKP, ALT, Na, Cl, ALB, BUN, Ca, CREAT, TBIL, TP, HDL, LDL, CHOL, TRIG). Intended for use by trained healthcare workers in clinical/ancillary facilities.

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

Microtainer Brand Chemistry Tubes With Microgard Closure (K991702)

Reference Devices

BD Microtainer® Contact-Activated Lancet (K223243)
Greiner Bio-One Vacuette® Serum Tubes with Clot Activator and Gel Separator

Related Devices

K982998 — GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE · Greiner Meditech, Inc. · Oct 21, 1998
K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube · Becton, Dickinson and Company · Nov 27, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. Food & Drug Administration" next to it. December 1, 2023 Becton Dickinson and Company Katherine Lemus Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 ## Re: K230391 Trade/Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SSTTM Capillary Blood Collection Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: October 31, 2023 Received: October 31, 2023 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 (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" {1}------------------------------------------------ 2 (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). 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 (QS) 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. # Marianela Perez-torres -S Marianela Perez-Torres, Ph.D 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230391 Device Name BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube #### Indications for Use (Describe) BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG). BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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}------------------------------------------------ BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 Becton, Dickinson and Company #### 510(K) SUMMARY #### Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube #### Summary Preparation Date: 11/28/2023 ## Submitted by: Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885 Phone: (201) 847-6800 ## Contact: Katherine Kenner Lemus Staff Regulatory Affairs Specialist Email: katherine.lemus(@bd.com Phone: (801) 541-9274 # Proprietary Names: The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) includes the following components: - BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) ● - BD MiniDraw™ Finger Sleeve ● - BD MiniDraw™ Finger Sizing Tool ● - BD MiniDraw™ Capillary Tube Adapter SST™ ● - BD MiniDraw™ Cap Removal Tool . These devices are components of the BD MiniDraw™ Capillary Blood Collection System. #### Common Names: FDA Product Code Name(s): Tubes, Vials, Systems, Serum Separators, Blood Collection {4}------------------------------------------------ Becton, Dickinson and Company #### Regulatory Information Regulatory information for devices included in this submission is as follows: Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code(s): JKA #### Predicate Device Predicate: K991702 BD Microtainer® SSTTM #### Device Establishment Becton, Dickinson and Company Registration Number: 2243072 #### Performance Standards 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 ASTM D999-08(2015) Standard Test Methods for Vibration Testing of Shipping Containers ASTM D4728-17 Standard Test Method for Random Vibration Testing of Shipping Containers ASTM D6653/D6653M-13(2021) Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method ASTM D5276-19 Standard Test Method for Drop Test of Loaded Containers by Free Fall ASTM D5264-98(2019) Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester ISO/IEC 15415:2011 Information technology -----------------------------------------------------------------------------------------------------------------------------------techniques - Bar code symbol print quality test specification - Two-dimensional symbols ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems {5}------------------------------------------------ Becton, Dickinson and Company ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials ISO 10993-17:2002 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of materials ISO 10993-23:2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation # Intended Use BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™M Finger Sleeve that are intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG). BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes. {6}------------------------------------------------ BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 Becton, Dickinson and Company Becton, Dickinson and Company ## Device Description The BD MiniDraw™ Capillary Blood Collection System family of devices is a capillary blood collection solution designed to collect, separate, transport, and store capillary blood samples from a finger stick that are clinically equivalent to both capillary and venous comparator tubes. The system is designed to standardize the capillary blood collection procedure, thereby allowing users who are trained to use the subject device, but who may not otherwise have been trained in phlebotomy, to collect fingerstick capillary blood samples. The BD MiniDraw™™ Capillary Blood Collection System is intended to be used by trained healthcare workers in ancillary healthcare facilities and clinical use environments (e.g., retail pharmacies, clinics). The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) is a subset of components in the BD MiniDraw™ Capillary Blood Collection System. It is intended to collect a whole blood specimen from a finger and deliver a serum sample for measurement of specific analytes listed in the Indication for Use. The BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) contains a silica-based clot activator solution and a gel that creates a barrier between serum and cells during centrifugation. The tube has a unique barcode that links the tube with the patient. The MiniDraw™ SST™ Tube is designed to be used in combination with the BD MiniDraw™ Finger Sleeve (available in four sizes), the BD Microtainer® Contact-Activated Lancet (clearance K223243), and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter SST™ and BD MiniDraw™ Cap Removal Tool. # Substantial Equivalence A comparison of the proposed and predicate device is provided in Table 1. A discussion of equivalence between the subject device and the predicate device is provided in Table 2. {7}------------------------------------------------ Becton, Dickinson and Company | Characteristic | Subject Device | Predicate | Comparison | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | MiniDraw™ SST™ System | BD Microtainer® SST™ K991702 | | | Indications for Use | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG). BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes. | The MICROTAINER® Brand Chemistry Tubes with MICROGARD™ Closures are intended to collect, transport and store skin puncture blood specimens for chemistry determination requiring serum or heparinized plasma. | Both devices are intended to collect, transport and store blood for testing serum for chemistry analytes. MiniDraw™ SST™ System is intended for capillary blood collection for chemistry determinations requiring serum. It is not intended for those determinations requiring heparinized plasma. | | Characteristic | Subject Device | Predicate | Comparison | | | MiniDraw™ SST™ System | BD Microtainer® SST™ | | | | | K991702 | | | Intended Population | Adults – individuals aged 18 and older, limited by correct fit of the Finger Sleeve | General Use – all populations | Use of the MiniDraw™ is limited to individuals aged 18 and older whose finger measurements match the available sizes of Finger Sleeves | | Intended Use Environment | Ancillary healthcare facilities, clinical and laboratory environments | Clinical and laboratory environments | MiniDraw™ SST™ System adds ancillary healthcare facility use environment | | Intended User | Trained Healthcare Workers: phlebotomists, clinicians, pharmacists, pharmacy technicians, and other healthcare workers trained in the use of the device | Trained Healthcare Workers: phlebotomists and clinicians | MiniDraw™ SST™ System adds pharmacists, pharmacy technicians, and other healthcare workers trained in the use of the device | | Analytes | Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG) | Chemistry analytes | MiniDraw™ SST™ System tests for labeled subset of analytes in the predicate devices. | | Characteristic | Subject Device | Predicate | Comparison | | | MiniDraw™ SST™ System | BD Microtainer® | | | | | SSTTM K991702 | | | Single Use | Yes | Yes | Identical | | Sterility | Non-sterile | Non-sterile | Identical | | Centrifugation | Cap Down | Cap Up | MiniDraw™ SST™ System is intended for centrifugation when oriented with the cap down (reverse centrifugation). | | Sample Type | Capillary | Capillary | Identical | | Additive | Clot activator and gel separator | Clot activator and gel separator | Identical | | Materials | Container: Polypropylene Collector: methylAcrylonitrileButedieneStyrene (mABS) Cap: Polypropylene + Thermoplastic elastomer (TPE) Finger Sleeve: Polypropylene + colorant | Container: Polypropylene Collector: Polypropylene Cap: High Density Polyethylene Finger Sleeve: N/A | MiniDraw™ SST™ System uses various different materials. | | Container Design | Flat bottomed with rounded recessed plug | Flat Bottomed with rounded recessed plug | Identical | | Container Dimensions | 13x40mm | 9x40mm | Varies by product | | Finger Sleeve | Yes | N/A | MiniDraw™ SST™ System introduces use of the Finger Sleeve | | Finger Sizing Tool | Yes | N/A | MiniDraw™ SST™ System introduces use of the finger sizing tool | | Characteristic | Subject Device MiniDrawTM SSTTM System | Predicate BD Microtainer® SSTTM K991702 | Comparison | | Cap Removal Tool | Yes | N/A | MiniDrawTM SSTTM System introduces use of the cap removal tool | | Shelf-Life | 9 months | 15 months | Varies by Product | # Table 1: Substantial Equivalence Comparison {8}------------------------------------------------ Becton, Dickinson and Company {9}------------------------------------------------ Becton, Dickinson and Company {10}------------------------------------------------ Becton, Dickinson and Company # Table 2: Substantial Equivalence Discussion | Difference | Substantial Equivalence to the Predicate | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Included Analytes/Panels | Both the subject and predicate device are intended to collect, transport and store capillary blood for analysis. The intended use statement for the predicate refers to "skin prick" collection instead of "capillary" but these are understood to be equivalent. | | | MiniDraw™ SST™ System is intended for a narrower subset of targeted analytes than the BD Microtainer® SST™ (i.e., chemistry). The selection of analytes included in this submission are supported by clinical testing which demonstrates that the results are clinically equivalent. | | | Because the proposed list of analytes is considered to be a subset of those cleared for use with the predicate device, this is not considered to be a new intended use. | | Intended Population | Intended for adult individuals aged 18 and older and whose fingers fit in one of the four finger sleeve sizes. | | Addition of Ancillary Healthcare Facility Use Environments | MiniDraw™ SST™ System is intended for use in laboratory and clinical use environments. Blood collection may also occur at ancillary healthcare facilities (e.g., retail pharmacies, retail clinics). This does not change the primary use of the device or the intended patient population and so this use environment does not result in a new intended use. Whether the intended trained user is capable of using the device appropriately has been validated (via Human Factors and Clinical testing). | | Difference | Substantial Equivalence to the Predicate | | Intended User | The device is designed for users who may not have been previously trained in phlebotomy but who are trained in the correct use of the MiniDrawTM SSTTM System (i.e., pharmacists, pharmacy technicians, and other healthcare workers trained in the use of the device). Ultimately, the users of both the subject and predicate devices post- training are considered to be "trained healthcare workers," so this difference is not considered a new intended use. The workflow steps of the subject device have been designed and carefully evaluated to ensure no new serious adverse events or use-related hazards that may negatively impact the overall benefit-risk profile of capillary blood collection devices were introduced when used by the intended users described in this submission. Human factors testing and clinical evaluations performed with the targeted user groups demonstrated no increase in risk of errors in the handling and processing of capillary blood samples (i.e., centrifuging, storage and transport) and there was no observed increase in erroneous downstream test results. | | Reverse Centrifugation | MiniDraw™ SSTTM Tube is designed to be centrifuged in the cap down position so that the gel separator and clot are centrifuged into the cap, which is removed and discarded prior to testing, maximizing the serum quantity available for sampling and reducing the possibility of probe contamination during testing. Regardless of the orientation during centrifugation, the assessment of appropriate gel formation, clot separation, and absence of leakage during centrifugation/handling are not new questions of safety or effectiveness. | | Materials | The BD MiniDraw™ SST™ Capillary Blood Collection Tube container is made from polypropylene the same as the predicate. The other materials used in the components of the subject device differ. The collector of the predicate is also made of polypropylene as it is molded in a single piece, and the collector of the MiniDraw™ SST™ Tube is made from mABS which is a clearer plastic material intended to enhance blood visualization during collection. The cap on the MiniDraw™ SSTTM Tube is made from Polypropylene and TPE to ensure seal integrity during reverse centrifugation. The BD MiniDrawTM Finger Sleeve, which does not have a matching analog from the predicate device, is made from polypropylene mixed with colorants that were found to be both appropriate for the intended use of the device and compatible with biocompatibility considerations. The assessment of whether these materials do not negatively impact device performance nor have any negative effects on clinical results are not new questions of safety or effectiveness. Non-Clinical Performance testing, Clinical testing, and Biocompatibility testing demonstrated the devices perform as intended. | | Difference | Substantial Equivalence to the Predicate | | Container Dimensions | The container dimensions of the MiniDrawTM SSTTM Tube are designed for optimal functioning of the device. For both the subject and predicate capillary devices, use of a tube adapter is common to ensure compatibility with test instruments, and thus tube dimensional differences do not raise new questions of safety or effectiveness. | | Combination Devices and Accessories | The MiniDrawTM SSTTM System is a subset of component devices that are intended to be used together during capillary blood collection and laboratory analysis. The MiniDrawTM SSTTM Tube is designed to be used in combination with the BD MiniDrawTM Finger Sleeve (available in four sizes) and three accessories; BD MiniDrawTM Finger Sizing Tool, BD MiniDrawTM Capillary Tube Adapter SSTTM and BD MiniDrawTM Cap Removal Tool. The sample volume and quality requirements exist for a capillary sample regardless of whether a patient's finger is squeezed by the Finger Sleeve or manually. The Finger Sizing Tool is optional as correct sizing of the Finger Sleeve may be assessed with the sleeve itself. Usage of a tube adapter…

BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube

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BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube