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

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ## I Background Information: A 510(k) Number K252378 B Applicant Becton, Dickinson and Company C Proprietary and Established Names BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JKA | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry | ## II Submission/Device Overview: A Purpose for Submission: Modified device B Measurand: Not applicable. Blood collection tube. C Type of Test: Not applicable. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} K252378 - Page 2 of 9 ## III Intended Use/Indications for Use: ### A Intended Use(s): See Indications for Use below. ### B Indication(s) 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 Albumin (ALB), Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Creatinine (CREAT), Glucose (GLU), Potassium (K), Sodium (Na), 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. ### C Special Conditions for Use Statement(s): Rx - For Prescription Use Only If the patient’s fingers do not fit in one of the four BD MiniDraw™ Finger Sleeve sizes, the MiniDraw™ SST™ System should not be used. ### D Special Instrument Requirements: Not applicable. ## IV Device/System Characteristics: ### A Device Description: The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube consists of the MiniDraw™ SST™ Tube and BD MiniDraw™ Finger Sleeve. None of the components of the candidate device are provided sterile. The MiniDraw™ SST™ Tube is a plastic blood collection tube intended to collect 435 to 635 µL of whole blood, indicated by two fill lines on the tube. The BD MiniDraw™ Finger Sleeve attaches the tube to the patient’s finger during sample collection. The single-use Finger Sleeves come in four sizes. The following items are provided separately: BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter SST™, and BD MiniDraw™ Cap Removal Tool. {2} K252378 - Page 3 of 9 ## B Principle of Operation: The BD MiniDraw™ Finger Sizing Tool is used to select the appropriately sized BD MiniDraw™ Finger Sleeve for the patient. After warming the patient’s hand, the Finger Sleeve is attached to the MiniDraw™ SST™ Tube and then the finger sleeve is slid onto the patient’s finger. The BD Microtainer® Contact-Activated Lancet (k223243), sold separately, is used to lance the finger. After puncture, the MiniDraw™ SST™ Tube is swung into position for blood collection. Immediately after the blood has been collected, the MiniDraw™ SST™ Tube is inverted 5 times to mix the blood with the additive. The MiniDraw™ SST™ Tube is placed in a cap-down orientation at room temperature for 45 minutes to allow for clotting. The MiniDraw™ SST™ Capillary Blood Collection Tube contains a silica-based clot activator solution and a gel that creates a barrier between serum and cells during centrifugation. After clotting is completed (<120 minutes from blood collection), the MiniDraw™ SST™ Tube should be centrifuged cap-down orientation. The recommended centrifugation conditions are: 4000 RCF (relative centrifuge force or g) for 2 minutes and 15 seconds. ## V Substantial Equivalence Information: ### A Predicate Device Name(s): BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube ### B Predicate 510(k) Number(s): K230391 ### C Comparison with Predicate(s): | Device & Predicate Device(s): | K252378 | K230391 | | --- | --- | --- | | Device Trade Name | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube | Same | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Collect, transport, and store fingerstick capillary blood specimens for downstream testing | Same | | Intended Use Environment | Ancillary healthcare facilities, clinical and laboratory environments | Same | {3} | Device & Predicate Device(s): | K252378 | K230391 | | --- | --- | --- | | Sample Type | Capillary, fingerstick | Same | | General Device Characteristic Differences | | | | MiniDraw™ SST™ System Shelf Life | 12 months | 9 months | | Analytes Tested | ALKP, ALT, AST, Na, Cl, ALB, BUN, Ca, CREAT, Glu, K, TBIL, TP, HDL, LDL, CHOL, TRIG, | ALKP, ALT, Na, Cl, ALB, BUN, Ca, CREAT, TBIL, TP, HDL, LDL, CHOL, TRIG | VI Standards/Guidance Documents Referenced: EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices ASTM F1886/F1886M-16 Standard Test Method for Determining Section 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 ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ANSI AAMI IEC 62366-1 :2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: a) Between Tube and Between Lot Variability A study was conducted to assess the total variability, lot-to-lot variation (between lots), and tube-to-tube (between tube) variation in the candidate device for downstream testing of aspartate aminotransferase (AST) and potassium (K). Samples were evaluated on two instrument platforms with at least three lots of BD MiniDraw™ SST™ Tubes to confirm tube performance. The study conducted on Platform 1 was performed using samples collected from 138 subjects. The study conducted on Platform 2 was performed using samples collected from 79 subjects. Contrived samples were also prepared in an effort to K252378 - Page 4 of 9 {4} cover extreme levels for the claimed analytes. Total, Between-Lot, and Between-Tube variability for each instrument platform are presented in the tables below. ## Instrument Platform 1 | Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | AST (U/L) | Total | 24.9 | 0.9 | 0.8 | 1 | 3.5 | 3.1 | 4 | | | Lot | | 0.2 | 0 | 0.3 | 0.8 | 0 | 1.4 | | | Tube | | 0.9 | 0.8 | 0.9 | 3.4 | 3.2 | 3.7 | | K (mmol/L) | Total | 4.155 | 0.019 | 0.017 | 0.022 | 0.5 | 0.4 | 0.5 | | | Lot | | 0 | 0 | 0 | 0 | 0 | 0 | | | Tube | | 0.018 | 0.017 | 0.019 | 0.4 | 0.4 | 0.5 | ## Instrument Platform 2 | Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | AST (U/L) | Total | 24.83 | 1.33 | 1.14 | 1.6 | 6.3 | 5.4 | 7.5 | | | Lot | | 0.53 | 0.47 | 0.6 | 2.6 | 2.3 | 2.9 | | | Tube | | 1.22 | 1.11 | 1.36 | 5.7 | 5.2 | 6.4 | | K (mmol/L) | Total | 4.146 | 0.023 | 0.02 | 0.028 | 0.6 | 0.5 | 0.7 | | | Lot | | 0.005 | 0.004 | 0.005 | 0.1 | 0.1 | 0.2 | | | Tube | | 0.023 | 0.021 | 0.026 | 0.6 | 0.5 | 0.6 | A separate study was conducted for glucose (Glu) using blood samples collected from 43 fasting participants (self-reported). Samples were evaluated on two instrument platforms to confirm tube performance. At least three of the candidate devices were evaluated. Contrived samples were prepared in an effort to cover extreme levels. Total, Between-Lot, and Between-Tube variability for each instrument platform are presented in the tables below. ## Instrument Platform 1 | Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Glu (mg/dL) | Total | 117.6 | 0.5 | 0.4 | 0.7 | 0.5 | 0.4 | 0.7 | | | Lot | | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | | | Tube | | 0.5 | 0.5 | 0.6 | 0.5 | 0.5 | 0.6 | K252378 - Page 5 of 9 {5} Instrument Platform 2 | Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Glu (mg/dL) | Total | 118.4 | 1.5 | 1.2 | 1.9 | 1.1 | 0.9 | 1.4 | | | Lot | | 0.4 | 0.3 | 0.4 | 0.2 | 0.2 | 0.2 | | | Tube | | 1.4 | 1.3 | 1.6 | 1.1 | 1.0 | 1.2 | b) Operator Variability A study was performed to evaluate operator-to-operator variability of the candidate device for AST, K and Glu using one instrument platform. A total of 257 participants were enrolled in the study. For each participant, two trained health care workers (e.g., pharmacists, pharmacy technicians, phlebotomists) each collected one sample into a single BD® MiniDraw™ SST™ Tube. Results from the same patient were compared to determine variability between operators. Results are presented in the table below. | Analyte | Mean | SD (95% CI) | %CV (95% CI) | | --- | --- | --- | --- | | AST (U/L) | 25.2 | 1.4 (1.2, 1.7) | 5.5 (4.8, 6.6) | | Glu (mg/dL) | 115.2 | 4 (3.2, 6) | 3.3 (2.6, 4.8) | | K (mmol/L) | 4.37 | 0.168 (0.144, 0.214) | 3.7 (3.2, 4.8) | 2. Linearity: Not applicable. 3. Analytical Specificity/Interference: Refer to K230391 for Analytical Specificity/Interference. 4. Assay Reportable Range: Not applicable. 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Shelf-life: Real Time stability testing of the BD MiniDraw™ Capillary Blood Collection System with the BD MiniDraw™ SST™ Capillary Blood Collection Tube showed that the candidate device is stable for 12 months when stored at 4 to 25°C. The stability study protocol and acceptance criteria has been reviewed and found to be acceptable. Analyte Stability (within-tube stability): Analyte stability studies were conducted to assess the analyte within-tube stability for AST, Glu and K. The study protocols and acceptance criteria were reviewed and found to be acceptable. These studies demonstrated within-tube type stability in the candidate K252378 - Page 6 of 9 {6} device for up to 4 hours at room temperature and up to 48 hours at refrigerated conditions. The following storage instructions are included in the device labeling: - Remove samples from centrifuge as soon as centrifugation is completed. - Samples stored and transported at room temperature between 20 and 27 °C (68.0–80.6 °F) must be tested within 4 hours of collection. - Samples stored and transported at refrigerated temperature between 2 and 8 °C (35.6–46.4 °F) must be tested within 48 hours of collection. - Exposing samples to temperatures below 2 °C (35.6 °F) or above 27 °C (80.6 °F) for prolonged duration may impact analyte results. Avoid exposure to direct light during sample storage and transport. ## Additional Testing Refer to k230391 for flex studies and additional benchtop studies demonstrating device durability over the shelf life including cap lid closure force, accidental drop seal, reverse centrifuge seal, transit vibration seal, cap / container pull-off, de-capping, tube to collector pull-off force, latch press force, tube to collector axial removal force, pivot attachment force, collector to finger cuff snap de-latch, friction retention, and packaging ship testing. 6. Detection Limit: Not applicable. 7. Assay Cut-Off: Not applicable. ## B Comparison Studies: 1. Method Comparison with Predicate Device: Method Comparison studies were performed to evaluate equivalence between the BD MiniDraw™ and BD Microtainer (k991702) and Greiner Bio-One Vacuette® Blood Collection Tubes with Clot Activator and Gel Separator (K081929) for AST, Glu and K. Capillary blood was collected into the BD® MiniDraw™ SST™ Tube and BD Microtainer® SST™ by trained operators (e.g., healthcare workers) and venous blood was collected into Greiner Vacuette® Serum by phlebotomists. Blood from 129 participants in fasting state were collected for testing glucose levels while AST and K were tested on samples collected from 160 participants representative of different diseases to cover measuring intervals. All samples were tested on two different instrument platforms, only the number of subjects with valid results from both the candidate device and the comparator devices were included for final analysis. Results for samples collected in the candidate device were compared to results for samples collected in the BD Microtainer and to results for samples collected in the Greiner Vacuette. Data was analyzed using Passing Bablok (PaBa) or Weighted Deming (W Dem) regression. Biases at medical decision levels (MDLs) between tube types were estimated with 95% confidence intervals and determined to be acceptable. Regression analyses are provided in the tables below: K252378 - Page 7 of 9 {7} Instrument Platform 1 | Analyte | Comparison | N of pairs | Reg Type | Slope (95% CI) | Intercept (95% CI) | r | | --- | --- | --- | --- | --- | --- | --- | | GLU (mg/dL) | vs BD Microtainer | 110 | W Dem | 1 (0.99, 1.0) | 0.01 (-0.81, 0.83) | 1 | | | vs Greiner Vacuette | 106 | W Dem | 1.01 (1.0, 1.02) | 0.39 (-0.65, 1.43) | 1 | | AST (U/L) | vs BD Microtainer | 105 | PaBa | 1 (1.0, 1.01) | -1.0 (-2.04, -1.0) | 1.0 | | | vs Greiner Vacuette | 130 | PaBa | 1.0 (0.99, 1) | 1.0 (0, 1.05) | 1.0 | | K (mmol/L) | vs BD Microtainer | 106 | PaBa | 0.96 (0.88, 1.01) | 0.06 (-0.17, 0.4) | 0.922 | | | vs Greiner Vacuette | 131 | PaBa | 0.98 (0.88, 1.06) | 0.17 (-0.18, 0.57) | 0.896 | Instrument Platform 2 | Analyte | Comparison | N of pairs | Reg Type | Slope (95% CI) | Intercept (95% CI) | r | | --- | --- | --- | --- | --- | --- | --- | | GLU (mg/dL) | vs BD Microtainer | 106 | W Dem | 1 (0.99, 1.01) | -0.22 (-1.03, 0.59) | 1 | | | vs Greiner Vacuette | 104 | W Dem | 1.01 (1.0, 1.02) | 0.18 (-0.93, 1.28) | 1 | | AST (U/L) | vs BD Microtainer | 103 | W Dem | 0.99 (0.95, 1.02) | -0.75 (-1.62, 0.12) | 0.999 | | | vs Greiner Vacuette | 130 | PaBa | 1.0 (1, 1) | 1.0 (0, 1.0) | 1.0 | | K (mmol/L) | vs BD Microtainer | 105 | PaBa | 0.95 (0.86, 1.02) | 0.08 (-0.21, 0.51) | 0.915 | | | vs Greiner Vacuette | 130 | PaBa | 0.99 (0.89, 1.07) | 0.1 (-0.25, 0.5) | 0.9 | 2. Matrix Comparison: Not applicable. C Clinical Studies: 1. Clinical Sensitivity: Not applicable. K252378 - Page 8 of 9 {8} 2. Clinical Specificity: Not applicable. 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable. D. Clinical Cut-Off: Not applicable. E. Expected Values/Reference Range: Not applicable. VIII. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K252378 - Page 9 of 9