BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

K252040 · Becton, Dickinson and Company · JKA · Mar 13, 2026 · Clinical Chemistry

Device Facts

• Record ID: K252040
• Device Name: BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
• Applicant: Becton, Dickinson and Company
• Product Code: JKA · Clinical Chemistry
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

BD Vacutainer® Plasma Separator Tubes (PST™) The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing. BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples. BD Vacutainer® Sodium Heparin Blood Collection Tubes The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional. The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.

Device Story

Evacuated, sterile, single-use plastic tubes; PET construction; BD Hemogard™ cap or rubber stopper; spray-dried lithium or sodium heparin anticoagulant; PST™ includes inert polymer separator gel. Used by healthcare professionals for venous blood collection; controlled vacuum draws specific blood volume. Inversion (8-10 times) mixes blood with anticoagulant; centrifugation (1,100-1,300 RCF for PST™; 1,300 RCF for Sodium Heparin) moves gel to form plasma barrier. Output is separated plasma for in vitro diagnostic testing. Enables clinical chemistry and cardiac marker analysis; facilitates laboratory workflow by providing stable plasma samples.

Clinical Evidence

Bench testing only. Multi-part studies evaluated precision (repeatability, lot-to-lot, tube-to-tube) across multiple instrument platforms (Roche, Beckman Coulter, Siemens, OCD). Method comparison studies (n=180) against Greiner Bio-One Vacuette tubes demonstrated acceptable accuracy via Passing Bablok/Deming regression (slopes 0.95-1.05, high correlation coefficients). Stability studies confirmed analyte integrity for specified durations at room temperature and refrigerated conditions.

Technological Characteristics

PET plastic evacuated tubes; spray-dried lithium or sodium heparin anticoagulant; inert polymer separator gel (PST™ only); BD Hemogard™ or conventional rubber stoppers. Sterilized via gamma irradiation (ISO 11137). Dimensions: 13x75mm, 13x100mm, 16x100mm. No software or electronic components.

Indications for Use

Indicated for healthcare professionals to collect, contain, and transport human venous blood specimens for in vitro diagnostic testing. PST™ tubes are for plasma chemistry analyte testing; Sodium Heparin tubes are for plasma lithium testing. Contraindicated for COHb testing (PST™) and sodium measurement (Sodium Heparin tubes).

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

• Vacutainer® Brand Plus PST™ Plasma Separation Tube (K945952)
• Vacutainer® Brand Plus Sodium Heparin Tube (K944566)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K252040

B Applicant

Becton, Dickinson and Company

C Proprietary and Established Names

BD Vacutainer® Plasma Separator Tubes (PST™)

BD Vacutainer® Sodium Heparin Blood Collection Tubes

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:

Modification of existing 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}

K252040 - Page 2 of 23

# III Intended Use/Indications for Use:

## A Intended Use(s):

See Indications for Use below.

## B Indication(s) for Use:

**BD Vacutainer® Plasma Separator Tubes (PST™)**

The BD Vacutainer® PST™ Blood Collection Tubes are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing.

BD Vacutainer® PST™ Blood Collection Tubes are used for testing in chemistry analytes in plasma samples.

**BD Vacutainer® Sodium Heparin Blood Collection Tubes**

The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional.

The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.

## Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

**BD Vacutainer® Plasma Separator Tubes (PST™)**

Do not use if foreign matter is present or if tube is damaged.

Follow your facility’s procedures if clots or other visible obstructions are present in the plasma sample as this could lead to the inability to test the sample.

Separation of plasma from the cells should take place within 2 hours of collection to prevent potentially erroneous test results.

Any change in blood collection tube type, size, handling, processing, or storage condition for a particular laboratory assay should be evaluated by the laboratory to verify the current reference range or to establish a new reference range for each instrument/reagent system per the laboratory’s standard procedures.

Venous blood gas samples collected with plastic tubes made from polyethylene terephthalate (PET), including BD Vacutainer® Plasma Separator Tubes (PST™), should not be used when testing carboxyhemoglobin (COHb). A clinically significant positive bias for COHb may occur.

BD Vacutainer® Plasma Separator Tubes (PST™) may contain trace levels of ethylbenzene and xylene. It has not been determined if the presence of trace levels of these or other compounds

{2}

will affect test results in chromatography-based assays and the performance of BD Vacutainer® Plasma Separator (PST™) with chromatographic assays has not been evaluated.

Hydrophobic drugs have been known to adsorb to the gel of gel separator tubes, which may result in lower measured drug concentrations. However, these effects depend on various factors including the chemical and physical properties of the drug, contact time with the gel, volume of the sample on the gel, storage temperature, and gel type. Users should consider these factors when evaluating the use of gel separator tubes for drug testing and monitoring. See Drug Absorption in the References section.

Do not use BD Vacutainer® Plasma Separator Tubes (PST™) for Lithium measurement.

## BD Vacutainer® Sodium Heparin Blood Collection Tubes

Do not use if foreign matter is present or if tube is damaged

Examine tubes prior to use. Do not use the tube if the additive is missing, discolored, or if foreign matter or precipitate is present.

Separation of plasma from the cells should take place within 2 hours of collection to prevent potentially erroneous test results. Follow your facility’s procedures if clots or other visible obstructions are present in the specimen as this could lead to the inability to test the specimen.

Any change in blood collection tube type, size, handling, processing, or storage condition for a particular laboratory assay should be evaluated by the laboratory to verify the current reference range or to establish a new reference range for each instrument/reagent system per the laboratory’s standard procedures.

BD Vacutainer® Sodium Heparin Blood Collection Tubes may contain trace levels of ethylbenzene, formate, and xylene. It has not been determined if the presence of trace levels of these compounds will affect test results in chromatography-based assays and the performance of Vacutainer® Sodium Heparin Blood Collection Tubes with chromatographic assays has not been evaluated.

Do not use BD Vacutainer® Sodium Heparin Blood Collection Tubes containing Sodium Heparin for Sodium measurement.

BD Vacutainer® Sodium Heparin Blood Collection Tubes are only validated for use with Lithium in plasma and have not been evaluated for molecular or general chemistry testing in whole blood or plasma

## C Special Instrument Requirements:

Not applicable

K252040 - Page 3 of 23

{3}

K252040 - Page 4 of 23

## IV Device/System Characteristics:

### A Device Description:

BD Vacutainer® Plasma Separator Tubes (PST™) and Sodium Heparin Blood Collection Tubes are plastic, sterile, single use tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant, and 3) a spray-dried anti-coagulated formulated from lithium or sodium heparin. The BD Vacutainer® Plasma Separator Tubes (PST™) additionally includes an inert polymer separator gel. All stoppers/shields are color coded to reflect additive type and/or intended use.

BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes are available in various size configurations as applicable (13x75 mm, 13x100 mm and 16x100 mm), with nominal draw volumes ranging from 3mL to 10mL. The tubes contain additives dependent upon the specified fill volume and the desired additive to blood ratio for the tube.

### B Principle of Operation:

The BD Vacutainer® Plasma Separator Tubes (PST™), and Sodium Heparin Blood Collection Tubes use controlled vacuum to draw a specific volume of blood into the sterile interior of the tube. Within the tube, an anticoagulant (lithium heparin or sodium heparin) prevents the blood from clotting and enables the separation of plasma for testing. In the BD Vacutainer® Plasma Separator Tubes (PST™) a separator gel is also present at the tube bottom. The density of this material causes it to move upward during centrifugation to form a barrier separating plasma from the cellular elements.

The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices, Holders and Adapters. Once the vein of the patient has been penetrated using a standard needle, the collection tube is centered in the holder and pushed onto the needle, puncturing the stopper of the tube. Immediately after the blood has been drawn, the tube is gently inverted 8-10 times to mix the blood with the anticoagulant. The recommended centrifugation conditions are 1,100-1,300 RCF (relative centrifuge force or g) for 10 minutes for the BD Vacutainer® Plasma Separator Tubes (PST™) and 1,300 RCF for 10 minutes for the BD Vacutainer® Sodium Heparin Blood Collection Tubes.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

Vacutainer® Brand Plus PST™ Plasma Separation Tube, Vacutainer® Brand Plus Sodium Heparin Tube

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

K945952, K944566

{4}

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K252040 | K945952 |
| --- | --- | --- |
| Device Trade Name | BD Vacutainer® PST™ Blood Collection Tube | VACUTAINER® BRAND PLUS PST™ PLASMA SEPARATION TUBE |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Used for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing. | Same |
| Evacuated Blood Collection Tube | Yes | Same |
| Sample Type | Plasma | Same |
| Additive Type | Lithium Heparin | Same |
| General Device Characteristic Differences | | |
| Tube Draw Volumes | 3 mL, 3.5mL, and 4.5mL | 3 mL, 3.5mL, 4.5mL, 8 mL |
| Device & Predicate Device(s): | K252040 | K944566 |
| --- | --- | --- |
| Device Trade Name | BD Vacutainer® Sodium Heparin Blood Collection Tube | VACUTAINER® BRAND PLUS SODIUM HEPARIN TUBE |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Evacuated blood collection tube for the collection, containment, transport of human venous blood specimens, and as required, the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing | Same |

K252040 - Page 5 of 23

{5}

| Evacuated Blood Collection Tube | Yes | Same |
| --- | --- | --- |
| Sample Type | Plasma | Same |
| Additive Type | Sodium Heparin | Same |
| General Device Characteristic Differences | | |
| Tube Draw Volumes | 4 mL, 6 mL, and 10 mL | 2 mL, 4 mL, 6 mL, and 10 mL |

# VI Standards/Guidance Documents Referenced:

ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)].

ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]

ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

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.

AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile".

ISO 14971 Third Edition 2019-12 5-125. Medical Devices – Application of risk management to medical devices.

# VII Performance Characteristics (if/when applicable):

# A Analytical Performance:

The following table provides abbreviations for the analytes used in the validation testing of the candidate devices.

| Abbreviation | Analyte | Abbreviation | Analyte |
| --- | --- | --- | --- |
| ALB | Albumin | IgA | Immunoglobulin A |
| ALKP | Alkaline Phosphatase | IgG | Immunoglobulin G |
| ALT | Alanine Aminotransferase | IgM | Immunoglobulin M |
| AMY | Amylase | K | Potassium |
| AST | Aspartate Aminotransferase | LDH | Lactate Dehydrogenase |

K252040 - Page 6 of 23

{6}

| Abbreviation | Analyte | Abbreviation | Analyte |
| --- | --- | --- | --- |
| BUN | Blood Urea Nitrogen | LDL | Low-Density Lipoprotein |
| C3 | Complement Component 3 | LH | Luteinizing Hormone |
| Ca | Calcium | Lip | Lipase |
| Chol | Cholesterol | Li | Lithium |
| CK | Creatine Kinase | Mg | Magnesium |
| CKMB | Creatine Kinase-MB | Na | Sodium |
| CL | Chloride | NT-proBNP | N-Terminal Pro-B-Type Natriuretic Peptide |
| CO2 | Carbon Dioxide | Phos | Phosphorus |
| CORT | Cortisol | PROG | Progesterone |
| Creat | Creatinine | RF | Rheumatoid Factor |
| CRP | C-Reactive Protein | TBIL | Total Bilirubin |
| DBIL | Direct Bilirubin | TESTO | Testosterone |
| E2 | Estradiol | TnI | Troponin I |
| Fe | Iron | TnT | Troponin T |
| FERR | Ferritin | Total T3 | Total Triiodothyronine |
| FOLATE | Folate | Total T4 | Total Thyroxine |
| Free T3 | Free Triiodothyronine | TP | Total Protein |
| Free T4 | Free Thyroxine | TPSA | Total Prostate-Specific Antigen |
| FSH | Follicle-Stimulating Hormone | TRF | Transferrin |
| GGT | Gamma-Glutamyl Transferase | Trig | Triglycerides |
| GLUC | Glucose | TSH | Thyroid-Stimulating Hormone |
| HAPT | Haptoglobin | UA | Uric Acid |
| HCG | Human Chorionic Gonadotropin | VIT B12 | Vitamin B12 |
| HDL | High-Density Lipoprotein | VIT D | Vitamin D |
| hsTnI | High-Sensitivity Troponin I | | |

1. Precision/Reproducibility:

A multi-part study was conducted to evaluate repeatability (within tube), lot-to-lot reproducibility and tube-to-tube reproducibility of BD Vacutainer® Plasma Separator Tubes (PST™) and Sodium Heparin Blood Collection Tubes for select analytes. Testing of select analytes were conducted across the following instruments: Roche cobas e411, Roche cobas Integra 400 Plus, Beckman Coulter Access 2, Beckman Coulter AU480.

BD Vacutainer® Plasma Separator Tubes (PST™)

Blood was collected from each subject (n=62) into 6 BD Vacutainer® PST Tubes.

Specimens were tested in duplicate per tube (except the initial 20 subjects who were tested in singlicate) with 2 tubes per lot across 3 lots on 1-2 instrument platforms for the following

K252040 - Page 7 of 23

{7}

select analytes: ALT, LDH, C3, Ca, Cl, K, Phos, TPSA, TBIL, TP, Gluc, Trig, Cortisol, Free T4, Total T4, Testosterone, IgG, TnT and hsTnI. Contrived samples were also prepared to cover the entire clinical measuring range for some analytes as necessary. Total, Between-Lot, Between-Tube, and Within-Tube variability for each instrument platform are presented in the tables below.

BD Vacutainer® Plasma Separator Tubes (PST™)

| Test System | Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter AU480 | ALT (U/L) | 24.2 | Between Lots | 2.4 | 2.1%, 2.9% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 4 | 3.5%, 4.7% |
| | | | Total | 4.6 | 3.7%, 6.1% |
| Roche cobas Integra 400 Plus | ALT (U/L) | 24.69 | Between Lots | 0.7 | 0.6%, 0.8% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 5.3 | 4.6%, 6.3% |
| | | | Total | 5.4 | 4.3%, 7.1% |
| Beckman Coulter AU480 | TBIL (mg/dL) | 1.3 | Between Lots | 3.1 | 2.7%, 3.7% |
| | | | Between Tubes | 3.6 | 2.4%, 4.4% |
| | | | Within Tubes | 4 | 3.5%, 4.7% |
| | | | Total | 6.2 | 5.1%, 8.1% |
| Roche cobas Integra 400 Plus | TBIL (mg/dL) | 1.445 | Between Lots | 0.4 | 0.3%, 0.5% |
| | | | Between Tubes | 2.7 | 0%, 4.2% |
| | | | Within Tubes | 5.5 | 4.8%, 6.5% |
| | | | Total | 6.2 | 4.9%, 8.2% |
| Roche cobas Integra 400 Plus | C3 (mg/dL) | 129.15 | Between Lots | 0.4 | 0.3%, 0.4% |
| | | | Between Tubes | 1.5 | 1.1%, 1.7% |
| | | | Within Tubes | 1.2 | 1.1%, 1.4% |
| | | | Total | 2 | 1.6%, 2.5% |
| Roche cobas 6000 | C3 (mg/dL) | 140 | Between Lots | 0.70 | 0.6%, 0.9% |
| | | | Between Tubes | 1.20 | 0.7%, 1.5% |
| | | | Within Tubes | 1.80 | 1.6%, 2.0% |
| | | | Total | 2.20 | 1.8%, 3.0% |
| Beckman Coulter AU480 | Ca (mg/dL) | 8.88 | Between Lots | 0.2 | 0.1%, 0.2% |
| | | | Between Tubes | 0.5 | 0.3%, 0.7% |
| | | | Within Tubes | 0.8 | 0.7%, 0.9% |
| | | | Total | 1 | 0.8%, 1.3% |
| Roche cobas Integra 400 Plus | Ca (mg/dL) | 8.793 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 0.3 | 0%, 1% |
| | | | Within Tubes | 1.7 | 1.5%, 2% |
| | | | Total | 1.8 | 1.4%, 2.3% |
| Beckman Coulter AU480 | CL (mmol/L) | 99.8 | Between Lots | 0.3 | 0.3%, 0.4% |
| | | | Between Tubes | 0.4 | 0.3%, 0.5% |
| | | | Within Tubes | 0.4 | 0.3%, 0.4% |
| | | | Total | 0.7 | 0.5%, 0.9% |
| | CL (mmol/L) | 97.87 | Between Lots | 0.4 | 0.3%, 0.4% |
| | | | Between Tubes | 0.2 | 0.1%, 0.3% |

K252040 - Page 8 of 23

{8}

| Test System | Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- | --- |
| Roche cobas Integra 400 Plus | | | Within Tubes | 0.4 | 0.3%, 0.4% |
| | | | Total | 0.6 | 0.5%, 0.7% |
| Beckman Coulter Access 2 | CORT (ug/dL) | 9.09 | Between Lots | 0.5 | 0.4%, 0.6% |
| | | | Between Tubes | 2.3 | 0%, 3.2% |
| | | | Within Tubes | 3.8 | 3.3%, 4.5% |
| | | | Total | 4.5 | 3.6%, 5.9% |
| Roche cobas e411 | CORT (ug/dL) | 8.822 | Between Lots | 0.4 | 0.3%, 0.5% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 3.9 | 3.4%, 4.6% |
| | | | Total | 3.9 | 3.2%, 5.1% |
| Beckman Coulter AU480 | GLUC (mg/dL) | 143.5 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 2.8 | 2.4%, 3.2% |
| | | | Within Tubes | 1.1 | 1%, 1.2% |
| | | | Total | 3 | 2.5%, 3.9% |
| Roche cobas Integra 400 Plus | GLUC (mg/dL) | 143.2 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 2.7 | 2.2%, 3.2% |
| | | | Within Tubes | 1.9 | 1.7%, 2.2% |
| | | | Total | 3.4 | 2.7%, 4.3% |
| Beckman Coulter AU480 | IgG (mg/dL) | 1130.126 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 1.4 | 1%, 1.7% |
| | | | Within Tubes | 1.3 | 1.1%, 1.5% |
| | | | Total | 1.9 | 1.5%, 2.5% |
| Roche cobas Integra 400 Plus | IgG (mg/dL) | 1176.41 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 1.3 | 1%, 1.6% |
| | | | Within Tubes | 1.1 | 0.9%, 1.3% |
| | | | Total | 1.7 | 1.4%, 2.2% |
| Beckman Coulter AU480 | K (mmol/L) | 3.9 | Between Lots | 1.7 | 1.5%, 2% |
| | | | Between Tubes | 3.1 | 2.6%, 3.6% |
| | | | Within Tubes | 0.9 | 0.8%, 1% |
| | | | Total | 3.7 | 3%, 4.7% |
| Roche cobas Integra 400 Plus | K (mmol/L) | 3.876 | Between Lots | 1.3 | 1.2%, 1.6% |
| | | | Between Tubes | 2.5 | 2%, 2.8% |
| | | | Within Tubes | 1.1 | 0.9%, 1.2% |
| | | | Total | 3 | 2.4%, 3.9% |
| Beckman Coulter AU480 | LDH (U/L) | 147.9 | Between Lots | 2.1 | 1.8%, 2.6% |
| | | | Between Tubes | 5.2 | 4.3%, 6% |
| | | | Within Tubes | 1.3 | 1.1%, 1.6% |
| | | | Total | 5.8 | 4.6%, 7.6% |
| Roche cobas Integra 400 Plus | LDH (U/L) | 166.85 | Between Lots | 2.5 | 2.1%, 3% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 3.7 | 3.1%, 4.5% |
| | | | Total | 4.4 | 3.6%, 5.9% |
| | Phos (mg/dL) | 3.13 | Between Lots | 0.4 | 0.3%, 0.4% |
| | | | Between Tubes | 0.6 | 0%, 1% |
| | Phos (mg/dL) | 3.13 | Between Lots | 0.4 | 0.3%, 0.4% |
| | | | Between Tubes | 0.6 | 0%, 1% |

K252040 - Page 9 of 23

{9}

| Test System | Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter AU480 | | | Within Tubes | 1.6 | 1.4%, 1.8% |
| | | | Total | 1.7 | 1.4%, 2.2% |
| Roche cobas Integra 400 Plus | Phos (mg/dL) | 3.05 | Between Lots | 0.3 | 0.3%, 0.4% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 1.8 | 1.6%, 2.1% |
| | | | Total | 1.8 | 1.5%, 2.4% |
| Beckman Coulter AU480 | TP (g/dL) | 7.09 | Between Lots | 0.2 | 0.2%, 0.3% |
| | | | Between Tubes | 1.1 | 0.9%, 1.3% |
| | | | Within Tubes | 0.7 | 0.6%, 0.8% |
| | | | Total | 1.4 | 1.1%, 1.8% |
| Roche cobas Integra 400 Plus | TP (g/dL) | 6.82 | Between Lots | 0.1 | 0.1%, 0.1% |
| | | | Between Tubes | 1.1 | 0.8%, 1.3% |
| | | | Within Tubes | 0.8 | 0.7%, 1% |
| | | | Total | 1.4 | 1.1%, 1.8% |
| Beckman Coulter Access 2 | TPSA (ng/mL) | 2.825 | Between Lots | 3.8 | 3.1%, 4.7% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 4.8 | 4.2%, 5.6% |
| | | | Total | 6.1 | 4.7%, 8.5% |
| Roche cobas e411 | TPSA (ng/mL) | 3.0411 | Between Lots | 0.5 | 0.4%, 0.6% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 2.1 | 1.8%, 2.4% |
| | | | Total | 2.2 | 1.7%, 3% |
| Beckman Coulter Access 2 | Total T4 (ug/dL) | 8.328 | Between Lots | 1.3 | 1.1%, 1.5% |
| | | | Between Tubes | 1.7 | 0%, 2.7% |
| | | | Within Tubes | 3.6 | 3.1%, 4.3% |
| | | | Total | 4.2 | 3.4%, 5.5% |
| Roche cobas e411 | Total T4 (ug/dL) | 7.382 | Between Lots | 1 | 0.9%, 1.3% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 4.3 | 3.7%, 5.1% |
| | | | Total | 4.4 | 3.6%, 5.8% |
| Beckman Coulter Access 2 | Free T4 (ng/dL) | 0.836 | Between Lots | 0.2 | 0.2%, 0.3% |
| | | | Between Tubes | 1.3 | 0%, 1.9% |
| | | | Within Tubes | 2.5 | 2.2%, 2.9% |
| | | | Total | 2.8 | 2.3%, 3.6% |
| Roche cobas e411 | Free T4 (ng/dL) | 1.2402 | Between Lots | 0.8 | 0.7%, 1% |
| | | | Between Tubes | 0 | 0%, 0% |
| | | | Within Tubes | 2.4 | 2.2%, 2.8% |
| | | | Total | 2.6 | 2.1%, 3.3% |
| Beckman Coulter Access 2 | TESTO (ng/dL) | 2.697 | Between Lots | 1 | 0.9%, 1.2% |
| | | | Between Tubes | 3.9 | 2.8%, 4.8% |
| | | | Within Tubes | 4.3 | 3.8%, 4.9% |
| | | | Total | 5.9 | 4.8%, 7.5% |
| Roche cobas e411 | TESTO (ng/dL) | 3.1862 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 1.3 | 0%, 2.1% |

K252040 - Page 10 of 23

{10}

| Test System | Analyte (Unit) | Mean | Variance Component | CV (%) | CV 95% CI |
| --- | --- | --- | --- | --- | --- |
| | | | Within Tubes | 3.3 | 2.9%, 3.8% |
| | | | Total | 3.5 | 2.9%, 4.6% |
| Beckman Coulter AU480 | Trig (mg/dL) | 194.3 | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 1.1 | 0.8%, 1.3% |
| | | | Within Tubes | 0.9 | 0.8%, 1.1% |
| | | | Total | 1.4 | 1.2%, 1.9% |
| Roche cobas Integra 400 Plus | Trig (mg/dL) | 179.3 | Between Lots | 0.1 | 0.1%, 0.1% |
| | | | Between Tubes | 0.6 | 0%, 1.1% |
| | | | Within Tubes | 1.5 | 1.3%, 1.8% |
| | | | Total | 1.6 | 1.3%, 2.1% |

BD Vacutainer® Sodium Heparin Blood Collection Tube

A study was conducted to evaluate the repeatability (within-tube), lot-to-lot (between lots), tube-to-tube (between tube) and total variation in the BD Vacutainer® Sodium Heparin Blood Collection Tube when testing lithium. To carry out the testing, plasma was drawn from 20 individual subjects using non-additive tubes, the plasma was then pooled per patient, and lithium was spiked into the pooled plasma of each subject. The samples were then transferred to six BD NaHep tubes per subject and tested. Three lots of tubes were used in the study. All samples were run in duplicate on two instrument platforms. The results are summarized in the table below.

BD Vacutainer® Sodium Heparin Blood Collection Tube

| Test System | Analyte | Mean | Variance Component | CV% | CV 95% CI |
| --- | --- | --- | --- | --- | --- |
| Roche cobas 6000 | Li | 0.606 mmol/L | Between Lots | 0 | 0%, 0% |
| | | | Between Tubes | 0 | NA |
| | | | Within Tubes | 4.60% | 4.1%, 5.2% |
| | | | Total | 4.6% | 3.5%, 6.7% |
| Siemens Atellica | Li | 0.606 mmol/L | Between Lots | 0.80 | 0.7%, 1.1% |
| | | | Between Tubes | 0.00 | NA |
| | | | Within Tubes | 2.90 | 2.5%, 3.3% |
| | | | Total | 3.00 | 2.3%, 4.3% |

2. Linearity:

Not applicable.

3. Analytical Specificity/Interference:

Benchtop studies were conducted to evaluate interference from stopper materials over the sample storage time. Study protocols, acceptance criteria and results for this study were provided and found to be acceptable.

K252040 - Page 11 of 23

{11}

4. Detection Limit and Assay Reportable Range:

Not applicable.

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

a. Specimen Stability

Multiple analyte stability studies were conducted to assess the analyte within-tube stability for representative analytes in BD Vacutainer® Plasma Separator Tubes (PST™). Within-tube stability was assessed in the BD Vacutainer® Plasma Separator Tubes (PST™) after 12 hour storage at room temperature for CO2 only, after 18 hour storage at room temperature for Glucose and CO2, and for all other analytes listed below after 24-hour storage at room temperature. In addition, within tube stability after 3 days of refrigerated and 7 days of refrigerated storage was assessed for all analytes except Glucose and CO2. Stability was also assessed in the BD Vacutainer® Sodium Heparin Blood Collection Tubes after 2 hour storage at room temperature for Lithium. Samples tested had analyte concentrations that covered the measuring range for the assays used for testing each analyte and important medical decision levels for each tested analyte. Systematic bias between the test storage condition and baseline (0-2 hours after collection) was assessed for each analyte, and it was determined that the bias observed in these studies supports the storage claims included in the devices' labeling.

BD Vacutainer® Plasma Separator Tubes (PST™)

| Analyte | Temperature Condition | Storage Duration |
| --- | --- | --- |
| CO2 | Room temperature (23-27°C) | 12 hours |
| GLUC | Room temperature (23-27°C) | 18 hours |
| ALB | Room temperature (23-27°C) | 24 hours |
| ALKP | | |
| AMY | | |
| AST | | |
| BUN | | |
| Ca | | |
| CL | | |
| Chol | | |
| CK | | |
| CREAT | | |
| CKMB | | |
| C3 | | |
| CORT | | |
| CRP | | |
| DBIL | | |
| E2 | | |
| FERR | | |

K252040 - Page 12 of 23

{12}

| Folate
FSH
Free T4
Free T3
GGT
HAPT
HDL
hsTnI
HCG
Fe
IgA
IgG
IgM
LH
LDH
Lip
LDL
Mg
NT-ProBNP
Phos
K
PROG
RF
TPSA
TESTO
Total T3
Total T4
TRF
TSH
Na
TBIL
TP
Trig
TnT
UA
VIT B12
VIT D | | |
| --- | --- | --- |
| ALKP
AST
C3
Fe
LDH
Phos | Refrigerated (2-8°C) | 3 days |
| ALB
ALT
AMY
BUN
Ca | Refrigerated (2-8°C) | 7 days |

K252040 - Page 13 of 23

{13}

K252040 - Page 14 of 23

CL
Chol
CK
Creat
DBIL
GGT
Lip
Mg
Na
TBIL
TP
Trig
UA
CKMB
CORT
E2
FERR
Folate
FSH
Free T4
Free T3
HAPT
hsTnI
HCG
IgA
IgG
IgM
LH
NT-ProBNP
PROG
RF
TESTO
TPSA
Total T3
Total T4
TRF
TSH
TnT
VIT B12
VIT D

BD Vacutainer® Sodium Heparin Blood Collection Tubes

| Analyte | Temperature Condition | Storage Duration |
| --- | --- | --- |
| Li | Room temperature (23-27°C) | 2 hours |

{14}

b. Shelf Life

Real Time Shelf-life stability testing was conducted by using BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes. The results support the shelf-life claims of 12 months, and 16-17 months when stored at 25°C (and 40°C for 15 days to simulate extreme temperatures during shipping) for BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes respectively.

c. Additional bench testing

Benchtop studies were conducted to assess draw volume, X-value, stopper/shield separation, stopper leakage, tube leakage, drop breakage, centrifuge breakage, and the trace metal content prior to blood draw. The study protocols were reviewed, and performance was considered acceptable.

6. Assay Cut-Off: Not applicable

B Comparison Studies:

1. Method Comparison with Predicate Device: Not applicable
2. Matrix Comparison: Not applicable.

C Clinical Studies:

1. Clinical Sensitivity: Not applicable
2. Clinical Specificity: Not applicable
3. Clinical Cut-Off: Not applicable
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Routine chemistry analytes

A study was conducted to evaluate equivalence between BD Vacutainer® Plasma Separator Tubes (PST™) and Greiner Bio-One Vacuette Lithium Heparin Separator tubes for testing

K252040 - Page 15 of 23

{15}

representative analytes. A total of 180 participants were included in the study. Blood was collected from each study participant using standard phlebotomy techniques. In addition, contrived samples were prepared to cover the analytical measurement interval for the tested analytes. Samples were tested on two different instrument platforms (Beckman Coulter UniCel DxC AU480 and Roche cobas Integra 400 Plus). For each analyte and tube comparison, data was analyzed using Passing Bablok, Deming or Weighted Deming regression. Regression analyses for each tube type comparison were assessed and determined to demonstrate acceptable accuracy. Regression parameter estimates are provided in the tables below. Biases at important medical decision levels for each analyte between tube types were estimated with 95% confidence intervals and determined to be acceptable

Regression Parameter Estimates: BD Vacutainer® Plasma Separator Tubes (PST™) vs. Greiner Bio-One Vacuette Lithium Heparin Separator tubes

| Instrument | Analyte | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- |
| Beckman Coulter AU480 | ALB (g/dL) | 0.99 (0.95, 1.04) | 0.02 (-0.16, 0.21) | 0.968 |
| Roche cobas® Integra 400 Plus | ALB (g/dL) | 0.98 (0.92, 1.04) | 0.07 (-0.2, 0.34) | 0.925 |
| Beckman Coulter AU480 | ALKP (U/L) | 0.99 (0.97, 1) | 0.71 (-0.12, 1.54) | 0.997 |
| Roche cobas® Integra 400 Plus | ALKP (U/L) | 1 (0.97, 1.02) | -0.08 (-2.08, 1.92) | 0.996 |
| Beckman Coulter AU480 | ALT (U/L) | 0.99 (0.97, 1.01) | 0.23 (-0.34, 0.79) | 1 |
| Roche cobas® Integra 400 Plus | ALT (U/L) | 1 (0.99, 1.02) | -0.37 (-0.77, -0.04) | 0.999 |
| Beckman Coulter AU480 | AMY (U/L) | 1.02 (0.98, 1.05) | -0.59 (-1.92, 0.73) | 0.986 |
| Roche cobas® Integra 400 Plus | AMY (U/L) | 1 (0.99, 1.01) | -0.23 (-0.78, 0.33) | 0.998 |
| Beckman Coulter AU480 | AST (U/L) | 1.05 (0.99, 1.11) | -0.64 (-1.52, 0.24) | 0.998 |
| Roche cobas® Integra 400 Plus | AST (U/L) | 1.01 (0.98, 1.04) | -0.25 (-0.73, 0.23) | 1 |
| Beckman Coulter AU480 | BUN (mg/dL) | 1 (1, 1.02) | 0.05 (-0.19, 0.1) | 1 |
| Roche cobas® Integra 400 Plus | BUN (mg/dL) | 1.01 (1, 1.03) | -0.12 (-0.43, 0.1) | 0.999 |
| Beckman Coulter AU480 | CK (mg/dL) | 1 (1, 1.01) | 1 (-0.55, 1) | 0.996 |
| Roche cobas® Integra 400 Plus | CK (mg/dL) | 1 (0.98, 1.01) | -0.11 (-1.22, 1.01) | 0.997 |
| Beckman Coulter AU480 | CL (mmol/L) | 0.99 (0.93, 1.04) | 1.53 (-3.9, 6.95) | 0.951 |
| Roche cobas® Integra 400 Plus | CL (mmol/L) | 1.02 (0.99, 1.06) | -1.82 (-5.32, 1.69) | 0.964 |

K252040 - Page 16 of 23

{16}

K252040 - Page 17 of 23
| Instrument | Analyte | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- |
| Beckman Coulter AU480 | CO2 (mmol/L) | 0.97 (0.91, 1.02) | 0.97 (-0.4, 2.34) | 0.953 |
| Roche cobas® Integra 400 Plus | CO2 (mmol/L) | 1.03 (0.96, 1.1) | -1.03 (-2.6, 0.54) | 0.935 |
| Beckman Coulter AU480 | Ca (mg/dL) | 1 (0.93, 1.08) | 0 (-0.71, 071) | 0.985 |
| Roche cobas® Integra 400 Plus | Ca (mg/dL) | 0.97 (0.93, 1.01) | 0.26 (-0.1, 0.62) | 0.958 |
| Beckman Coulter AU480 | Chol (mg/dL) | 1 (0.98, 1.02) | -0.22 (-4.04, 3.6) | 0.995 |
| Roche cobas® Integra 400 Plus | Chol (mg/dL) | 1.01 (0.98, 1.03) | -1.94 (-6.45, 2.57) | 0.99 |
| Beckman Coulter AU480 | Creat (mg/dL) | 1.03 (1.01, 1.05) | 0 (-0.02, 0.01) | 1 |
| Roche cobas® Integra 400 Plus | Creat (mg/dL) | 0.99 (0.97, 1.01) | 0.01 (-0.01, 0.03) | 1 |
| Beckman Coulter AU480 | DBIL (mg/dL) | 0.88 (0.81, 0.95) | 0.01 (0, 0.02) | 0.908 |
| Roche cobas® Integra 400 Plus | DBIL (mg/dL) | 1.07 (0.8, 1.33) | 0 (-0.02, 0.01) | 0.774 |
| Beckman Coulter AU480 | Fe (μg/dL) | 1 (0.98, 1.02) | -1.71 (-2.87, -0.55) | 0.998 |
| Roche cobas® Integra 400 Plus | Fe (μg/dL) | 1.02 (0.99, 1.05) | -1.86 (-3.64, -0.08) | 0.996 |
| Beckman Coulter AU480 | GGT (U/L) | 0.99 (0.98, 1.01) | 0.39 (0, 0.78) | 1 |
| Roche cobas® Integra 400 Plus | GGT (U/L) | 0.99 (0.98, 1) | 0.03 (-0.2, 0.43) | 1 |
| Beckman Coulter AU480 | GLUC (mg/dL) | 1.02 (0.98, 1.06) | -0.92 (-4.82, 2.99) | 0.992 |
| Roche cobas® Integra 400 Plus | GLUC (mg/dL) | 1.03 (1.01, 1.06) | -1.62 (-4.45, 1.2) | 0.998 |
| Beckman Coulter AU480 | HDL (mg/dL) | 1 (0.97, 1) | 0 (-1, 1.12) | 0.978 |
| Roche cobas® Integra 400 Plus | HDL (mg/dL) | 1.01 (0.98, 1.04) | -0.6 (-1.83, 0.63) | 0.983 |
| Beckman Coulter AU480 | K (mmol/L) | 0.96 (0.87, 1.06) | 0.23 (-0.13, 0.59) | 0.893 |
| Roche cobas® Integra 400 Plus | K (mmol/L) | 0.96 (0.85, 1.07) | 0.25 (-0.15, 0.66) | 0.875 |
| Beckman Coulter AU480 | LDH (U/L) | 1.02 (1, 1.07) | -1.51 (-7.23, 2) | 0.953 |
| Roche cobas® Integra 400 Plus | LDH (U/L) | 1.01 (0.96, 1.06) | -0.08 (-6.83, 6.67) | 0.953 |
| Beckman Coulter AU480 | LDL (mg/dL) | 0.99 (0.98, 1.01) | 0.73 (-1.76, 3.22) | 0.997 |

{17}

| Instrument | Analyte | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- |
| Roche cobas® Integra 400 Plus | LDL (mg/dL) | 1.03 (0.99, 1.07) | -3.75 (-8.55, 1.04) | 0.995 |
| Beckman Coulter AU480 | Lip (U/L) | 0.98 (0.92, 1.03) | 0.55 (-0.77, 1.87) | 0.986 |
| Roche cobas® Integra 400 Plus | Lip (U/L) | 1 (0.99, 1.01) | 0 (-0.26, 0.27) | 0.998 |
| Beckman Coulter AU480 | Mg (mg/dL) | 0.99 (0.98, 1) | -0.01 (-0.03, 0.02) | 0.995 |
| Roche cobas® Integra 400 Plus | Mg (mg/dL) | 0.99 (0.94, 1.04) | -0.03 (-0.13, 0.07) | 0.965 |
| Beckman Coulter AU480 | Na (mmol/L) | 1 (0.97, 1.03) | -0.27 (-4.36, 3.82) | 0.97 |
| Roche cobas® Integra 400 Plus | Na (mmol/L) | 1 (0.99, 1.01) | 0.86 (-0.58, 2.29) | 0.996 |
| Beckman Coulter AU480 | Phos (mg/dL) | 0.98 (0.92, 1.04) | 0.1 (-0.07, 0.28) | 0.963 |
| Roche cobas® Integra 400 Plus | Phos (mg/dL) | 0.99 (0.96, 1.02) | 0.05 (-0.05, 0.14) | 0.981 |
| Beckman Coulter AU480 | TBIL (mg/dL) | 1 (0.99, 1.01) | -0.01 (-0.02, 0) | 1 |
| Roche cobas® Integra 400 Plus | TBIL (mg/dL) | 1 (1, 1.04) | 0 (-0.01, 0.01) | 1 |
| Beckman Coulter AU480 | TP (g/dL) | 0.98 (0.9, 1.06) | 0.1 (-0.47, 0.68) | 0.912 |
| Roche cobas® Integra 400 Plus | TP (g/dL) | 0.95 (0.88, 1.02) | 0.36 (-0.16, 0.87) | 0.956 |
| Beckman Coulter AU480 | Trig (mg/dL) | 0.99 (0.98, 1.01) | -0.52 (-2.73, 1.69) | 0.998 |
| Roche cobas® Integra 400 Plus | Trig (mg/dL) | 1 (0.99, 1.01) | -2.08 (-3.29, -0.87) | 0.999 |
| Beckman Coulter AU480 | UA (mg/dL) | 0.99 (0.95, 1.02) | 0.07 (-0.1, 0.23) | 0.982 |
| Roche cobas® Integra 400 Plus | UA (mg/dL) | 0.98 (0.95, 1.02) | 0.09 (-0.06, 0.24) | 0.988 |

# Special Chemistry Analytes and Cardiac Markers

A study was conducted to evaluate equivalence between A) BD Vacutainer® Plasma Separator Tubes (PST™) and Greiner Bio-One Vacuette Lithium Heparin Separator and B) BD Vacutainer® Sodium Heparin Blood Collection Tubes and Greiner Sodium Heparin Blood Collection Tubes for testing special chemistry analytes and cardiac markers. Blood was collected from each study participant using standard phlebotomy techniques. In addition, contrived samples were prepared to cover the analytical measurement interval for the tested analytes. Samples were tested on two different instrument platforms for each analyte tested.

K252040 - Page 18 of 23

{18}

For each analyte and tube comparison, data was analyzed using Passing Bablok regression, Deming or Weighted Deming regression. Regression analyses for each tube type comparison were assessed and determined to demonstrate acceptable accuracy. Regression parameter estimates are provided in the tables below. Biases at important medical decision levels for each analyte between tube types were estimated with 95% confidence intervals and determined to be acceptable.

Regression Parameters for BD Vacutainer® Plasma Separator Tubes (PST™) vs. Greiner Bio-One Vacuette LiHep Separator

| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| OCD Vitros 5600 | C3 | 130 | 0.99 (0.95, 1.03) | -0.6 (-4.83, 3.64) | 0.985 |
| Beckman Coulter DxC 700 AU | CKMB | 121 | 1 (0.97, 1.03) | 0.14 (-0.48, 0.76) | 0.995 |
| Roche cobas® e411 | CKMB | 125 | 1 (0.98, 1.01) | -0.01 (-0.05, 0.02) | 0.999 |
| OCD Vitros 5600 | CORT | 115 | 0.99 (0.99, 1) | 0.31 (-1.15, 1.78) | 0.998 |
| Roche cobas® e411 | CORT | 116 | 0.98 (0.98, 0.99) | 0.4 (-0.18, 0.98) | 0.999 |
| Beckman Coulter DxC 700 AU | CRP | 128 | 1 (1, 1.01) | 0 (-0.02, 0.01) | 0.998 |
| OCD Vitros 5600 | CRP | 133 | 1 (0.99, 1) | 0 (0, 0.02) | 0.999 |
| OCD Vitros 3600/5600 | E2 | 113 | 1.01 (0.98, 1.02) | 2.96 (0.66, 7.09) | 0.999 |
| Siemens Dimension Vista 1500 | E2 | 117 | 0.99 (0.98, 1.01) | -0.75 (-1.49, 0.41) | 0.999 |
| OCD Vitros 3600/5600 | FERR | 109 | 0.95 (0.94, 0.96) | 0.09 (-0.04, 0.22) | 0.999 |
| Siemens Dimension Vista 1500 | FERR | 107 | 0.99 (0.98, 0.99) | -0.09 (-0.29, 0.11) | 1 |
| OCD Vitros 3600/5600 | FOLATE | 102 | 1.02 (0.98, 1.07) | 0.35 (0, 0.75) | 0.948 |
| Siemens Dimension Vista 1500 | FOLATE | 129 | 1.02 (0.99, 1.04) | 0.27 (-0.04, 0.6) | 0.987 |
| OCD Vitros 3600/5600 | FSH | 109 | 0.99 (0.99, 1) | -0.02 (-0.04, 0) | 1 |
| Siemens Dimension Vista 1500 | FSH | 112 | 1 (0.99, 1) | 0.01 (-0.02, 0.05) | 1 |

K252040 - Page 19 of 23

{19}

K252040 - Page 20 of 23
| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Roche cobas® Integra 400 Plus | HAPT | 100 | 1 (0.99, 1.01) | -0.45 (-1.67, 0.77) | 0.998 |
| OCD Vitros 5600 | HAPT | 100 | 1.01 (0.99, 1.02) | -0.72 (-2.56, 1.13) | 0.996 |
| OCD Vitros 3600/5600 | HCG | 85 | 1 (0.99, 1.01) | -0.04 (-0.16, 0.08) | 1 |
| Siemens Dimension Vista 1500 | HCG | 98 | 1 (0.99, 1.01) | 0 (-0.01, 0.01) | 1 |
| Beckman Coulter DxC 700 AU | IgA | 123 | 1 (1, 1.01) | -0.58 (-1.59, 0.43) | 0.998 |
| OCD Vitros 5600 | IgA | 121 | 0.97 (0.96, 0.98) | 1.25 (-0.15, 2.65) | 0.997 |
| Beckman Coulter DxC 700 AU | IgG | 127 | 1.03 (1.02, 1.04) | -18.38 (-28.29, -8.47) | 0.998 |
| OCD Vitros 5600 | IgG | 129 | 0.98 (0.96, 1) | 7.78 (-8.56, 24.12) | 0.993 |
| Beckman Coulter DxC 700 AU | IgM | 118 | 0.98 (0.95, 1.01) | 1.5 (-1.11, 4.11) | 0.999 |
| OCD Vitros 5600 | IgM | 117 | 0.98 (0.97, 1) | -0.19 (-1.18, 0.8) | 0.999 |
| OCD Vitros 3600/5600 | LH | 107 | 1 (0.99, 1) | -0.04 (-0.07, -0.01) | 1 |
| Siemens Dimension Vista 1500 | LH | 111 | 1 (1, 1) | 0 (-0.02, 0) | 1 |
| OCD Vitros 5600 | NT-proBNP | 126 | 0.99 (0.99, 1) | -0.07 (-0.85, 0.7) | 1 |
| Roche cobas® e411 | NT-proBNP | 119 | 1 (0.99, 1) | -2.23 (-4.51, 0.05) | 1 |
| OCD Vitros 3600/5600 | PROG | 125 | 1 (0.99, 1.01) | 0.09 (0.04, 0.11) | 1 |
| Siemens Dimension Vista 1500 | PROG | 104 | 1 (0.98, 1.01) | 0.05 (0.04, 0.07) | 1 |
| OCD Vitros 5600 | TPSA | 107 | 0.99 (0.98, 0.99) | 0 (0, 0.01) | 1 |
| Roche cobas® e411 | TPSA | 111 | 0.99 (0.99, 1) | 0 (0, 0.01) | 1 |

{20}

K252040 - Page 21 of 23
| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Beckman Coulter DxC 700 AU | RF | 59 | 1.02 (1, 1.04) | -0.69 (-1.2, -0.19) | 0.995 |
| OCD Vitros 5600 | RF | 73 | 1 (0.99, 1.02) | -0.17 (-0.75, 0.41) | 0.999 |
| Beckman Coulter Access 2 | Total T3 | 110 | 0.97 (0.9, 1.03) | 0.06 (0.01, 0.11) | 0.98 |
| Roche cobas® e411 | Total T3 | 112 | 0.96 (0.91, 1.01) | 0.03 (-0.03, 0.1) | 0.959 |
| OCD Vitros 3600/5600 | Free T3 | 112 | 1.04 (0.96, 1.11) | -0.15 (-0.58, 0.28) | 0.967 |
| Siemens Dimension Vista 1500 | Free T3 | 117 | 1.01 (0.98, 1.03) | 0 (-0.06, 0.07) | 0.995 |
| OCD Vitros 3600/5600 | Total T4 | 109 | 1.01 (0.99, 1.03) | -1.01 (-3.24, 1.22) | 0.994 |
| Siemens Dimension Vista 1500 | Total T4 | 116 | 1 (0.96, 1.04) | -0.05 (-0.38, 0.28) | 0.979 |
| Beckman Coulter Access 2 | Free T4 | 109 | 1.04 (1.01, 1.07) | -0.03 (-0.06, 0) | 0.987 |
| Roche cobas® e411 | Free T4 | 111 | 1 (0.98, 1.01) | 0 (-0.02, 0.01) | 0.997 |
| OCD Vitros 5600 | TESTO | 128 | 1.07 (1.05, 1.08) | 0.09 (0.06, 0.12) | 0.998 |
| Roche cobas® e411 | TESTO | 117 | 0.97 (0.96, 0.99) | 0.01 (0, 0.02) | 0.998 |
| Roche cobas® Integra 400 Plus | TRF | 100 | 0.99 (0.97, 1.01) | 1.62 (-3.82, 7.05) | 0.993 |
| OCD Vitros 5600 | TRF | 102 | 0.99 (0.97, 1) | 1.91 (-1.02, 4.84) | 0.996 |
| OCD Vitros 3600/5600 | TSH | 121 | 0.99 (0.98, 1) | 0 (-0.01, 0.01) | 1 |
| Siemens Dimension Vista 1500 | TSH | 127 | 0.99 (0.98, 1) | 0 (-0.01, 0.01) | 1 |
| Beckman Coulter Access 2 | TnI | 103 | 1.02 (1, 1.04) | 0 (0, 0) | 0.998 |
| Roche cobas® e411 | TnI | 39 | 1.23 (1.12, 1.33) | -0.03 (-0.08, 0.03) | 0.99 |

{21}

| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Roche cobas® e411/e601 | TnT | 110 | 1.03 (1.01, 1.05) | 0.2 (-0.26, 0.66) | 1 |
| OCD Vitros 3600/5600 | VIT B12 | 110 | 0.99 (0.97, 1) | 4.57 (0.82, 8.33) | 0.998 |
| Siemens Dimension Vista 1500 | VIT B12 | 120 | 1.02 (1, 1.04) | -9.39 (-17.62, -1.16) | 0.999 |
| Beckman Coulter Access 2 | VIT D | 121 | 0.98 (0.95, 1.01) | 0.67 (0, 1.34) | 0.991 |
| Roche cobas® e411 | VIT D | 113 | 0.99 (0.94, 1.03) | -0.51 (-1.52, 0.51) | 0.987 |
| Siemens ADVIA Centaur XPT | hsTnI | 117 | 1 (1, 1.01) | -0.02 (-0.18, 0.13) | 1 |
| Beckman Coulter Access 2 | hsTnI | 132 | 1.01 (0.99, 1.02) | 0.07 (-0.14, 0.29) | 0.997 |

Regression Parameters for BD Vacutainer Sodium Heparin Blood Collection Tubes vs. Greiner Sodium Heparin Blood Collection Tubes

| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Roche cobas® c501 | Li | 100 | 1 (0.99, 1.01) | 0 (-0.01, 0.01) | 0.998 |
| Siemens Atellica | Li | 88 | 1 (1, 1.01) | 0 (-0.01, 0) | 1 |

An additional study was conducted to evaluate equivalence between BD Vacutainer® Plasma Separator Tubes (PST™) and Greiner Bio-One Vacuette LiHep Separator Tubes for C3 testing. A total of 89 participants were enrolled in the study. Blood was collected from each study participant using standard phlebotomy techniques. In addition, contrived samples were prepared to cover the analytical measurement interval for the tested analytes. Data was analyzed using Weighted Deming regression. Regression analysis was assessed and determined to demonstrate acceptable accuracy. Regression parameter estimates are provided in the tables below. Bias at important medical decision levels was estimated with 95% confidence intervals and determined to be acceptable

Regression Parameters for 4.5mL BD Vacutainer® Plasma Separator Tubes (PST™) vs. 5.0mL Greiner Bio-One Vacuette LiHep Separator

K252040 - Page 22 of 23

{22}

| Instrument | Analyte | N | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| Roche cobas 6000 | C3 | 89 | 1.01 (0.99, 1.03) | -0.92 (-3.53, 1.7) | 0.994 |

D 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.

K252040 - Page 23 of 23