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

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

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.

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

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K230391

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:

New 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

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## 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 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.

### 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.

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## 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):

Microtainer Brand Chemistry Tubes With Microgard Closure

### B Predicate 510(k) Number(s):

K991702

### C Comparison with Predicate(s):

| Device & Predicate Device(s): | K230391 | K991702 |
| --- | --- | --- |
| Device Trade Name | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube | Microtainer Brand Chemistry Tubes With Microgard Closure |
| General Device Characteristic Similarities | | |
| Intended Use | Collect, transport, and store fingerstick capillary blood specimens for downstream testing | Same |
| Sample Type | Capillary, fingerstick | Same |
| Additives | Clot activator and gel separator | Same |
| Tube Material | Polypropylene | Same |
| Sterilization Method | Not sterile | Same |
| General Device Characteristic Differences | | |
| Centrifugation | Cap Down | Cap Up |

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| Device & Predicate Device(s): | K230391 | K991702 |
| --- | --- | --- |
| Intended Use Environment | Ancillary healthcare facilities, clinical and laboratory environments | Clinical and laboratory environments |
| Intended Population | 18 years and older; limited by correct fit of the Finger Sleeve | All ages |
| Intended User | Trained healthcare workers: phlebotomists, clinicians, pharmacists, pharmacy technicians, and other healthcare workers trained in the use of the device | Phlebotomists and clinicians |
| Tube Closure | Cap: Polypropylene + Thermoplastic elastomer (TPE) | Polyethylene |
| Shelf Life | 9 months | 15 months |

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 the analytes specified in the indications for use (IFU). Samples were evaluated on two instrument platforms to confirm tube performance. At least three lots of the candidate device were

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evaluated. 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 cover extreme levels for the claimed analytes. Total, Between-Lot, and Between-Tube variability for each instrument platform are presented in the tables below.

Variance Components and Confidence Intervals (CI): Instrument Platform 1

| Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ALB (g/dL) | Total | 3.955 | 0.025 | 0.022 | 0.028 | 0.6 | 0.6 | 0.7 |
| | Lot | | 0.001 | 0 | 0.008 | 0 | 0 | 0.2 |
| | Tube | | 0.025 | 0.023 | 0.026 | 0.6 | 0.6 | 0.7 |
| ALKP (U/L) | Total | 79.1 | 0.4 | 0.4 | 0.5 | 0.7 | 0.6 | 0.7 |
| | Lot | | 0 | 0 | 0 | 0 | 0 | 0 |
| | Tube | | 0.4 | 0.4 | 0.5 | 0.7 | 0.6 | 0.6 |
| ALT (U/L) | Total | 27.2 | 0.8 | 0.7 | 0.9 | 4.7 | 4.2 | 5.4 |
| | Lot | | 0 | 0 | 0 | 0.2 | 0.2 | 0.2 |
| | Tube | | 0.8 | 0.7 | 0.8 | 4.7 | 4.4 | 5.0 |
| BUN (mg/dL) | Total | 18.3 | 0.4 | 0.4 | 0.5 | 2.2 | 2 | 2.5 |
| | Lot | | 0 | 0 | 0 | 0 | 0 | 0 |
| | Tube | | 0.4 | 0.4 | 0.4 | 2.2 | 2.1 | 2.3 |
| Ca (mg/dL) | Total | 9.73 | 0.08 | 0.07 | 0.09 | 0.8 | 0.7 | 1 |
| | Lot | | 0.02 | 0 | 0.03 | 0.2 | 0 | 0.3 |
| | Tube | | 0.08 | 0.07 | 0.08 | 0.8 | 0.8 | 0.9 |
| CHOL (mg/dL) | Total | 177.2 | 0.8 | 0.7 | 0.9 | 0.4 | 0.4 | 0.5 |
| | Lot | | 0.2 | 0 | 0.3 | 0.1 | 0 | 0.2 |
| | Tube | | 0.7 | 0.7 | 0.8 | 0.4 | 0.4 | 0.4 |
| Cl (mmol/L) | Total | 105.28 | 0.4 | 0.36 | 0.46 | 0.4 | 0.3 | 0.4 |
| | Lot | | 0.13 | 0.04 | 0.18 | 0.1 | 0 | 0.2 |
| | Tube | | 0.38 | 0.36 | 0.4 | 0.4 | 0.3 | 0.4 |
| CREAT (mg/dL) | Total | 0.962 | 0.017 | 0.015 | 0.019 | 1.7 | 1.5 | 2 |
| | Lot | | 0.002 | 0 | 0.006 | 0.2 | 0 | 0.6 |
| | Tube | | 0.017 | 0.016 | 0.018 | 1.7 | 1.6 | 1.8 |
| HDL (mg/dL) | Total | 50.86 | 0.63 | 0.56 | 0.73 | 1.2 | 1.1 | 1.4 |
| | Lot | | 0.17 | 0 | 0.26 | 0.3 | 0 | 0.5 |
| | Tube | | 0.61 | 0.57 | 0.65 | 1.2 | 1.1 | 1.3 |
| LDL (mg/dL) | Total | 115.93 | 0.92 | 0.82 | 1.06 | 0.8 | 0.7 | 0.9 |
| | Lot | | 0.13 | 0 | 0.32 | 0.1 | 0 | 0.3 |
| | Tube | | 0.91 | 0.86 | 0.98 | 0.8 | 0.7 | 0.8 |
| Na (mmol/L) | Total | 139 | 0.5 | 0.5 | 0.6 | 0.4 | 0.3 | 0.4 |
| | Lot | | 0.1 | 0 | 0.2 | 0.1 | 0 | 0.1 |
| | Tube | | 0.5 | 0.5 | 0.5 | 0.4 | 0.3 | 0.4 |
| TBIL (mg/dL) | Total | 0.7419 | 0.0089 | 0.0079 | 0.0102 | 1.2 | 1.1 | 1.4 |
| | Lot | | 0 | 0 | 0 | 0 | 0 | 0 |
| | Tube | | 0.0089 | 0.0085 | 0.0093 | 1.2 | 1.1 | 1.3 |

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Variance Components and Confidence Intervals (CI): Instrument Platform 2

| Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ALB (g/dL) | Total | 3.949 | 0.048 | 0.041 | 0.057 | 1.2 | 1 | 1.5 |
| | Lot | | 0.006 | 0.005 | 0.007 | 0.1 | 0.1 | 0.1 |
| | Tube | | 0.047 | 0.043 | 0.053 | 1.2 | 1.1 | 1.3 |
| ALKP (U/L) | Total | 93.64 | 1.47 | 1.26 | 1.78 | 1.4 | 1.2 | 1.7 |
| | Lot | | 0 | 0 | 0 | 0.4 | 0.4 | 0.5 |
| | Tube | | 1.47 | 1.34 | 1.63 | 1.3 | 1.2 | 1.5 |
| ALT (U/L) | Total | 32.872 | 1.615 | 1.381 | 1.946 | 7.4 | 6.3 | 8.8 |
| | Lot | | 0.271 | 0.242 | 0.307 | 0 | 0 | 0 |
| | Tube | | 1.592 | 1.449 | 1.767 | 7.4 | 6.7 | 8.2 |
| BUN (mg/dL) | Total | 15.627 | 0.287 | 0.245 | 0.346 | 2 | 1.7 | 2.4 |
| | Lot | | 0.046 | 0.041 | 0.052 | 0.7 | 0.6 | 0.8 |
| | Tube | | 0.283 | 0.257 | 0.314 | 1.8 | 1.6 | 2 |
| Ca (mg/dL) | Total | 9.309 | 0.072 | 0.062 | 0.087 | 0.8 | 0.7 | 0.9 |
| | Lot | | 0.016 | 0.014 | 0.018 | 0.2 | 0.2 | 0.2 |
| | Tube | | 0.071 | 0.064 | 0.078 | 0.8 | 0.7 | 0.8 |
| CHOL (mg/dL) | Total | 176.39 | 1.82 | 1.55 | 2.2 | 1 | 0.8 | 1.2 |
| | Lot | | 0.61 | 0.55 | 0.7 | 0.3 | 0.3 | 0.3 |
| | Tube | | 1.71 | 1.55 | 1.9 | 0.9 | 0.9 | 1 |
| Cl (mmol/L) | Total | 103.23 | 0.58 | 0.5 | 0.7 | 0.6 | 0.5 | 0.7 |
| | Lot | | 0.1 | 0.09 | 0.12 | 0.1 | 0.1 | 0.1 |
| | Tube | | 0.57 | 0.52 | 0.64 | 0.6 | 0.5 | 0.6 |
| CREAT (mg/dL) | Total | 0.9685 | 0.0266 | 0.0227 | 0.0322 | 2.6 | 2.2 | 3.1 |
| | Lot | | 0.0071 | 0.0063 | 0.0081 | 1.3 | 1.1 | 1.4 |
| | Tube | | 0.0257 | 0.0233 | 0.0285 | 2.2 | 2 | 2.5 |
| HDL (mg/dL) | Total | 54.79 | 0.52 | 0.44 | 0.62 | 0.8 | 0.7 | 1 |
| | Lot | | 0 | 0 | 0 | 0 | 0 | 0 |
| | Tube | | 0.52 | 0.47 | 0.57 | 0.8 | 0.8 | 0.9 |
| LDL (mg/dL) | Total | 105.76 | 1.3 | 1.1 | 1.58 | 1.1 | 1 | 1.4 |
| | Lot | | 0.54 | 0.48 | 0.62 | 0.4 | 0.3 | 0.4 |
| | Tube | | 1.18 | 1.07 | 1.31 | 1.1 | 1 | 1.2 |
| Na (mmol/L) | Total | 138.32 | 0.68 | 0.58 | 0.82 | 0.5 | 0.4 | 0.6 |

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| Analyte | Source | Mean | SD | SD 95% Lower Bound | SD 95% Upper Bound | %CV | %CV 95% Lower Bound | %CV 95% Upper Bound |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot | | 0.2 | 0.18 | 0.23 | 0.1 | 0.1 | 0.2 |
| | Tube | | 0.65 | 0.59 | 0.72 | 0.5 | 0.4 | 0.5 |
| TBIL (mg/dL) | Total | 0.7592 | 0.0326 | 0.0278 | 0.0394 | 4.1 | 3.5 | 5 |
| | Lot | | 0.026 | 0.0232 | 0.0296 | 0.4 | 0.4 | 0.5 |
| | Tube | | 0.0196 | 0.0178 | 0.0218 | 4.1 | 3.7 | 4.6 |
| TP (g/dL) | Total | 7.025 | 0.083 | 0.071 | 0.1 | 1.2 | 1 | 1.4 |
| | Lot | | 0.027 | 0.024 | 0.03 | 0.3 | 0.3 | 0.4 |
| | Tube | | 0.078 | 0.071 | 0.087 | 1.1 | 1 | 1.2 |
| TRIG (mg/dL) | Total | 172.48 | 3.39 | 2.89 | 4.1 | 1.8 | 1.6 | 2.2 |
| | Lot | | 1.08 | 0.96 | 1.23 | 0.5 | 0.5 | 0.6 |
| | Tube | | 3.21 | 2.92 | 3.57 | 1.8 | 1.6 | 2 |

b. Operator Variability

A study was performed to evaluate operator to operator variability of the candidate device for the analytes specified in the IFU. A total of 263 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 candidate device. Results from the same patient were compared to determine variability between operators. Results from testing samples on Instrument Platform 1 are presented in the table below.

Instrument Platform 1

| Analyte | Mean | SD (95% CI) | %CV (95% CI) |
| --- | --- | --- | --- |
| ALB (g/dL) | 3.82 | 0.04
(0.04, 0.04) | 1.1
(0.9, 1.2) |
| ALKP (U/L) | 75.3 | 0.8
(0.7, 1.1) | 1.1
(0.9, 1.7) |
| ALT (U/L) | 25.3 | 0.9
(0.8, 1.1) | 4.5
(3.8, 5.2) |
| BUN (mg/dL) | 16.1 | 0.4
(0.4, 0.5) | 2.7
(2.3, 3) |
| Ca (mg/dL) | 9.55 | 0.09
(0.08, 0.12) | 1
(0.8, 1.2) |
| CHOL (mg/dL) | 183.9 | 1.5
(1.3, 1.7) | 0.8
(0.7, 0.9) |
| Cl (mmol/L) | 107.8 | 0.5
(0.4, 0.6) | 0.5
(0.4, 0.6) |
| CREAT (mg/dL) | 0.798 | 0.014
(0.012, 0.016) | 1.9
(1.6, 2.2) |
| HDL (mg/dL) | 52.17 | 0.85
(0.67, 1.3) | 1.7
(1.3, 2.5) |
| LDL (mg/dL) | 123.61 | 1.08
(0.96, 1.24) | 0.9
(0.8, 1) |

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| Analyte | Mean | SD (95% CI) | %CV (95% CI) |
| --- | --- | --- | --- |
| Na (mmol/L) | 137.8 | 0.6
(0.6, 0.7) | 0.5
(0.4, 0.5) |
| TBIL (mg/dL) | 0.548 | 0.01
(0.009, 0.012) | 2.4
(2, 3.2) |
| TP (g/dL) | 6.67 | 0.05
(0.05, 0.06) | 0.8
(0.7, 0.9) |
| TRIG (mg/dL) | 174 | 5.2
(4.2, 6.9) | 3.7
(2.9, 5) |

Information was provided demonstrating that operator-to-operator variability is similar on Instrument Platform 2.

2. Linearity:

Not applicable.

3. Analytical Specificity/Interference:

Extractables and leachables (E&L) and outgassing testing were performed on the candidate device components to identify chemicals that could potentially contaminate the specimen and interfere with downstream testing. Study protocols, acceptance criteria and results for this testing were provided and found to be acceptable.

4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

a. 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 9 months when stored at 4 to 25 °C. The stability study protocol and acceptance criteria has been reviewed and found to be acceptable.

b. Analyte Stability

Analyte stability studies were conducted to assess the analyte within-tube stability for the analytes specified in the IFU. The study protocols and acceptance criteria have been reviewed and found to be acceptable. These studies demonstrated within-tube type stability in the candidate 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.

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- 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.

c. Transportation Study

A study was conducted to assess the analyte within-tube stability when exposed to simulated transportation conditions. Conditions evaluated included:

- Tube Orientation
- Extremes of temperature and humidity
- Vibration / Drop testing
- Altitude
- Light exposure
- Duration of transport

Study protocols and acceptance criteria have been reviewed, and performance was considered acceptable. The results of the study support that the tubes can be used to transport serum samples and that the physical tube integrity is maintained when subjected to the test conditions specified above. However, during prolonged exposure to high temperature and high humidity (i.e., extreme conditions outside the recommended transportation), some analytes are clinically impacted. To ensure appropriate handling during storage and transportation, the following instructions are included in the device labeling:

- Samples stored and transported at room temperature between 20–27 °C (68.0–80.6 °F) must be tested within 4 hours of collection.
- Samples stored and transported at refrigerated temperature between 2–8 °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.

d. Additional Bench Testing

i. A flex study was performed to evaluate the effect of various centrifugation conditions on sample quality and analyte stability in the candidate device. These included variations in the tube orientation (cap up or down), centrifugal force, and centrifugation time, acceleration, deceleration, and angle. Tube integrity and sample quality (i.e., barrier formation, hemolysis, red blood cells on barrier) were assessed and determined to be acceptable for all test conditions. Impact on downstream testing was assessed by calculating analyte bias between tubes exposed to test conditions and tubes handled according to the instructions for use. For all analytes tested and all test conditions, the mean bias between the test condition and the control condition was within the clinical acceptable limits (CAL). Separated serum volume and serum

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separation efficiency (%) was also assessed and determined to be acceptable for all test conditions. As a result of this testing, the following caution is included in the labeling:

Tubes that are centrifuged in the cap-up orientation may result in blood clot and gel below the serum in the tube. Please process according to your facility's standard instructions for sampling from capillary tubes (i.e., aliquot into micro sample cups, etc.)

ii. Additional benchtop studies were performed to demonstrate device durability over 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. Study protocols and acceptance criteria have been reviewed, and performance was considered acceptable.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:

A study was 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 the analytes claimed in the IFU.

Blood samples were collected at five collection sites representative of the various ancillary healthcare site settings of the intended use environment. These included a specialized collection site that collected blood from targeted disease state populations in an outpatient setting, retail pharmacies, and a patient service center.

Blood was collected from each participant into the capillary (candidate device and BD Microtainer® SST™) and venous (Greiner Vacuette Serum) study tubes. The operators (those collecting the capillary samples with the candidate device) were trained pharmacists and pharmacy technicians. Contrived samples were also prepared in an effort to cover the assay measurement ranges (AMR) for the analytes claimed in the IFU.

Samples were tested on two different instrument platforms. 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 the Greiner Vacuette. Data was analyzed using Passing Bablok (PB), Deming (Dem), or Weighted Deming (W Dem) regression. Biases between

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tube types were estimated with 95% intervals. Regression analyses are provided in the table below:

Instrument Platform 1

| Analyte | Comparison | N | Range Tested | Reg Type | Slope (95% CI) | Intercept (95% CI) | r |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ALB | vs BD Microtainer | 100 | 1.01, 5.54 | W Dem | 0.98 (0.98, 0.99) | 0.02 (0.01, 0.03) | 0.996 |
| | vs. Greiner Vacuette | 105 | 1.01, 5.47 | PB | 1 (1, 1) | 0 (-0.1, 0) | 0.982 |
| ALKP | vs BD Microtainer | 104 | 31, 644 | W Dem | 1 (0.99, 1.01) | -0.06 (-0.76, 0.63) | 1 |
| | vs. Greiner Vacuette | 110 | 31, 644 | W Dem | 0.99 (0.98, 1) | -0.24 (-0.81, 0.34) | 1 |
| ALT | vs BD Microtainer | 104 | 8, 756 | Dem | 1 (1, 1) | -0.62 (-0.91, -0.32) | 1 |
| | vs. Greiner Vacuette | 110 | 8, 756 | Dem | 1 (1, 1) | -0.79 (-1.07, -0.51) | 1 |
| BUN | vs BD Microtainer | 99 | 8, 115 | Dem | 0.99 (0.98, 1) | 0.01 (-0.21, 0.24) | 0.999 |
| | vs. Greiner Vacuette | 104 | 6, 115 | Dem | 1 (1, 1.01) | 0.08 (-0.22, 0.38) | 0.998 |
| Ca | vs BD Microtainer | 102 | 2.7, 13.6 | Dem | 1 (0.98, 1.01) | -0.04 (-0.19, 0.1) | 0.997 |
| | vs. Greiner Vacuette | 107 | 2.7, 13.6 | PB | 1 (1, 1.02) | -0.1 (-0.26, 0) | 0.99 |
| CHOL | vs BD Microtainer | 102 | 51, 454 | W Dem | 0.98 (0.98, 0.99) | 0.32 (-0.66, 1.31) | 0.999 |
| | vs. Greiner Vacuette | 107 | 51, 454 | PB | 0.99 (0.98, 1) | -0.87 (-3, 1.58) | 0.999 |
| Cl | vs BD Microtainer | 99 | 73.2, 146.0 | Dem | 1 (0.98, 1.02) | 0.03 (-1.9, 1.96) | 0.996 |
| | vs. Greiner Vacuette | 104 | 73.2, 146.0 | Dem | 0.99 (0.94, 1.03) | 3.42 (-1.29, 8.13) | 0.99 |
| CREAT | vs BD Microtainer | 100 | 0.23, 19.93 | PB | 1 (0.99, 1) | -0.01 (-0.01, 0) | 1 |
| | vs. Greiner Vacuette | 105 | 0.23, 19.93 | PB | 1 (0.99, 1) | -0.05 (-0.05, -0.04) | 1 |
| HDL | vs BD Microtainer | 97 | 21.5, 96.0 | W Dem | 0.97 (0.95, 0.99) | 0.43 (-0.37, 1.23) | 0.996 |
| | vs. Greiner Vacuette | 104 | 21.5, 108.6 | W Dem | 0.96 (0.94, 0.97) | 0.31 (-0.35, 0.98) | 0.997 |
| LDL | vs BD Microtainer | 100 | 32.8, 612.4 | W Dem | 0.99 (0.98, 0.99) | -0.18 (-0.65, 0.29) | 1 |
| | vs. Greiner Vacuette | 107 | 32.8, 612.4 | W Dem | 0.99 (0.98, 1) | -1 (-2.39, 0.4) | 1 |

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| Analyte | Comparison | N | Range Tested | Reg Type | Slope (95% CI) | Intercept (95% CI) | r |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Na | vs BD Microtainer | 102 | 90.8, 166.0 | Dem | 1 (0.98, 1.02) | -1.15 (-4.11, 1.82) | 0.996 |
| | vs. Greiner Vacuette | 107 | 90.8, 166.0 | PB | 1 (1, 1.05) | -1 (-8.33, 0) | 0.672 |
| TBIL | vs BD Microtainer | 97 | 0.170, 26.420 | PB | 1 (0.99, 1) | -0.01 (-0.01, 0) | 1 |
| | vs. Greiner Vacuette | 104 | 0.170, 26.420 | PB | 0.98 (0.97, 0.99) | -0.01 (-0.02, -0.01) | 1 |
| TP | vs BD Microtainer | 100 | 2.6, 10.2 | W Dem | 1 (0.98, 1.02) | -0.09 (-0.22, 0.05) | 0.996 |
| | vs. Greiner Vacuette | 105 | 2.6, 9.8 | W Dem | 0.99 (0.98, 1) | 0.03 (-0.03, 0.09) | 0.99 |
| TRIG | vs BD Microtainer | 97 | 32, 730 | PB | 0.99 (0.98, 1) | -1.36 (-3, 0.77) | 0.997 |
| | vs. Greiner Vacuette | 103 | 32, 730 | PB | 0.98 (0.96, 0.99) | 2.89 (0.64, 5.55) | 0.995 |

Instrument Platform 2

| Analyte | Comparison | N | Range Tested | Reg Type | Slope (95% CI) | Intercept (95% CI) | r |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ALB | vs BD Microtainer | 95 | 1.3, 5.4 | W Dem | 0.98 (0.96, 0.99) | 0.12 (0.04, 0.2) | 0.986 |
| | vs Greiner Vacuette | 104 | 1.3, 5.3 | W Dem | 0.95 (0.91, 0.98) | 0.14 (-0.02, 0.3) | 0.977 |
| ALKP | vs BD Microtainer | 97 | 27, 841 | W Dem | 1.01 (0.99, 1.02) | -0.2 (-1.32, 0.91) | 1 |
| | vs Greiner Vacuette | 109 | 27, 841 | W Dem | 0.99 (0.98, 1.01) | -0.6 (-1.47, 0.27) | 1 |
| ALT | vs BD Microtainer | 90 | 10, 480 | W Dem | 1 (0.98, 1.02) | -0.42 (-0.97, 0.13) | 1 |
| | vs Greiner Vacuette | 108 | 5, 480 | W Dem | 0.99 (0.98, 1) | 0.09 (-0.16, 0.33) | 1 |
| BUN | vs BD Microtainer | 94 | 3, 91 | Dem | 1.02 (1, 1.03) | -0.43 (-0.75, -0.11) | 0.999 |
| | vs Greiner Vacuette | 103 | 3, 91 | Dem | 1.01 (0.98, 1.05) | -0.22 (-0.83, 0.39) | 0.998 |
| Cl | vs BD Microtainer | 99 | 63.1, 138.1 | Dem | 1 (0.99, 1.02) | -0.49 (-2.17, 1.19) | 0.996 |
| | vs Greiner Vacuette | 110 | 63.1, 138.1 | Dem | 1.01 (0.99, 1.03) | -0.47 (-2.6, 1.67) | 0.994 |
| Ca | vs BD Microtainer | 97 | 2.8, 15.7 | PB | 1 (1, 1) | -0.1 (-0.1, 0) | 0.994 |

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| Analyte | Comparison | N | Range Tested | Reg Type | Slope (95% CI) | Intercept (95% CI) | r |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | vs Greiner Vacuette | 107 | 2.8, 14.8 | Dem | 0.99 (0.97, 1.01) | -0.01 (-0.2, 0.18) | 0.993 |
| CHOL | vs BD Microtainer | 92 | 60, 559 | W Dem | 1 (0.98, 1.02) | -1.04 (-4.9, 2.83) | 0.998 |
| | vs Greiner Vacuette | 101 | 60, 409 | W Dem | 1 (0.97, 1.03) | -3.74 (-9.5, 2.02) | 0.995 |
| CREAT | vs BD Microtainer | 99 | 0.3, 20.5 | Dem | 1 (0.99, 1.01) | -0.01 (-0.02, 0.01) | 1 |
| | vs Greiner Vacuette | 108 | 0.3, 15.1 | Dem | 1.01 (1, 1.01) | -0.06 (-0.07, -0.04) | 1 |
| HDL | vs BD Microtainer | 93 | 18, 117 | W Dem | 0.99 (0.97, 1.01) | 0.44 (-0.39, 1.27) | 0.998 |
| | vs Greiner Vacuette | 103 | 18, 117 | W Dem | 0.98 (0.96, 1) | 0.32 (-0.81, 1.44) | 0.997 |
| LDL | vs BD Microtainer | 94 | 38, 418 | W Dem | 0.99 (0.98, 1) | 0.34 (-0.54, 1.21) | 0.999 |
| | vs Greiner Vacuette | 104 | 38, 418 | W Dem | 0.98 (0.97, 0.99) | 0.05 (-1.01, 1.11) | 0.999 |
| Na | vs BD Microtainer | 98 | 86, 173 | Dem | 1.01 (0.99, 1.03) | -1.72 (-4.54, 1.09) | 0.995 |
| | vs Greiner Vacuette | 107 | 86, 173 | Dem | 1.01 (0.97, 1.04) | -2.1 (-6.91, 2.7) | 0.989 |
| TBIL | vs BD Microtainer | 91 | 0.2, 25.6 | Dem | 1 (0.97, 1.02) | 0 (-0.02, 0.02) | 1 |
| | vs Greiner Vacuette | 103 | 0.2, 25.6 | Dem | 0.98 (0.95, 1) | 0 (-0.02, 0.02) | 1 |
| TP | vs BD Microtainer | 96 | 2.0, 10.1 | W Dem | 1 (0.99, 1.01) | 0 (-0.03, 0.03) | 0.99 |
| | vs Greiner Vacuette | 107 | 2.0, 10.1 | W Dem | 0.99 (0.95, 1.02) | 0.02 (-0.21, 0.24) | 0.985 |
| TRIG | vs BD Microtainer | 92 | 36, 684 | PB | 0.99 (0.97, 1.01) | -2.51 (-5, 0.41) | 0.995 |
| | vs Greiner Vacuette | 102 | 36, 684 | W Dem | 0.96 (0.91, 1.01) | 3.95 (-1.82, 9.73) | 0.997 |

2. Matrix Comparison:
Not applicable.

C Clinical Studies:

1. Clinical Sensitivity:
Not applicable.

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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.

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