The VACUTAINER® Brand PLUS (plastic) Tube with EDTA and VACUTAINER® Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.

Blood collected in PLUS EDTA and PLUS Serum tubes can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

Device Description

The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.

The standard closure assembly is a basic rubber stopper. The tubes are also available with the VACUTAINER® Hemogard Closure Assembly, which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. The Hemogard closure assembly, intended to reduce user exposure to blood, was described in 510(k) Premarket Notification K945952 that received FDA clearance on January 18, 1995. All stopper/closures are color coded to reflect additive type (see the chart VACUTAINER® Tube Stopper/Closure Color Code Cross Reference located in the Product Insert, Attachment D)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant and VACUTAINER® Brand PLUS Serum Tube, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent performance for Immunohematology testing:	The results of the clinical evaluation demonstrate that the VACUTAINER® Brand PLUS (plastic) EDTA and PLUS Serum tubes provide equivalent results compared to the VACUTAINER® Brand (glass) Serum and EDTA tubes for immunohematology testing including:
- ABO Grouping	- ABO Grouping
- Rh typing	- Rh typing
- Antibody screening (requires red cells and plasma or serum)	- Antibody screening (requires red cells and plasma or serum)
General blood collection, transport, and processing (CDRH regulated uses):	The device is substantially equivalent to legally marketed predicate devices for general blood collection, transport, separating, and processing blood in a plastic tube. When used with VACUTAINER® Brand Needles and Holders, it is a closed system for venous blood collection with the same indications. (This is based on the FDA's CDRH substantial equivalence determination).

Note on Acceptance Criteria: The document primarily focuses on establishing "substantial equivalence" to predicate devices. For the stated expanded indications (immunohematology testing), the acceptance criterion is implicitly "equivalent results" compared to the predicate glass tubes. Specific quantitative thresholds for equivalence (e.g., within certain percentage difference for specific analytes, or perfect concordance in typing) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text for the clinical evaluation. The document only mentions "Clinical testing to evaluate the effectiveness of the additional Indications for Use... was performed."
Data Provenance: Not explicitly stated. There's no mention of the country of origin of the data, nor is it explicitly stated whether the study was retrospective or prospective. Given it's a premarket notification for a new indication, a prospective study design is more likely for safety and effectiveness, but this is not confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. The document states "Clinical testing... demonstrates equivalent performance," but it does not detail how individual results were evaluated or if "ground truth" was established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the summary. There is no mention of any adjudication process for the clinical test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study's aim was to demonstrate equivalent performance of the new plastic tubes compared to existing glass tubes for specific immunohematology tests. It was a comparison of device performance, not primarily a study on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a blood collection tube, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The ground truth (or reference standard) for the clinical evaluation was implicitly the results obtained from the predicate VACUTAINER® Brand (glass) Serum and EDTA tubes. The study aimed to show "equivalent results" using the new plastic tubes.
- For ABO Grouping, Rh typing, and antibody screening, the "ground truth" would be the established immunological reactions and interpretations obtained using standard methods with the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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JUN | 7 1998

K981013

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information I

This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

Establishment:• Address:	Becton Dickinson VACUTAINER Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
• Registration Number:	2243072
• Contact Person:	Eileen SchweighardtRegulatory Affairs ManagerTelephone no.: 201 - 847 - 4570Facsimile no.: 201 - 847 - 4858
• Date of Summary:	March, 1998
Device Name:• Trade Name:	VACUTAINER® Brand PLUS Tubewith EDTA Anticoagulant andVACUTAINER® Brand PLUS Serum Tube
• Classification Name :	Blood Specimen Collection Device
• Classification:	Class II
• Performance Standards:	None Established under 514 ofthe Food, Drug and Cosmetic Act

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination Substantial Equivalence Declaration: The term "Substantial Equivalence" is used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR § 807, Subpart E under which a device can be marketed without pre-market apporval or reclassification.

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· Device Description
The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.

· Intended Use

The VACUTAINER® Brand PLUS Tube with EDTA anticoagulant and the VACUTAINER Brand PLUS Serum Tube are evacuated blood collection tubes which provides a means collecting, transporting and processing blood in a closed plastic tube. Blood collected in a tube containing EDTA anticoagulant, VACUTAINER® Brand PLUS Tube with EDTA anticoagulant, is used primarily for clinical laboratory hematology studies. The VACUTAINER® Brand PLUS Serum Tube containing Silica activator is used primarily in clinical laboratory testing for chemistry assays.

In addition, the blood collected and processed in the VACUTAINER® Brand PLUS with EDTA anticoagulant and the VACUTAINER® Brand PLUS Serum Tube can be used immunohematology testing including ABO grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

· Synopsis of Test Methods and Results

Clinical testing to evaluate the effectiveness of the additional Indications for Use described in premarket notification was performed. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand PLUS (plastic) EDTA and PLUS Serum tubes provide equivalent results compared to the VACUTAINER® Brand (glass) Serum and EDTA tubes for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

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· Substantial Equivalence

Becton Dickinson VACUTAINER Systems believes that the VACUTAINER® Brand PLUS Tube with EDTA and VACUTAINER® Brand PLUS Serum Tube with the expanded Indications for Use is substantially equivalent to a commercially available blood collection tube. Clinical testing, as described in this premarket notification, demonstrates equivalent performance and effectiveness and supports the determination of substantial equivalence. The predicate devices, manufacturer, K number and clearance date are identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
VACUTAINERSystems	VACUTAINER®Brand Serum Tube	NotApplicable	Pre-Amendment Device and, therefore,exempt from premarket notificationrequirements according to the MDA of1976.
VACUTAINERSystems	VACUTAINER®Brand Tube with EDTAAnticoagulant	NotApplicable	Pre-Amendment Device and, therefore,exempt from premarket notificationrequirements according to the MDA of1976.

Elen Schuyraon

Eileen Schweighardt Regulatory Affairs Manager Regulatory Affairs Department

March 16, 1998 Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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JUN 17 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Eileen Schweighardt Regulatory Affairs Manager Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417

Re : K981013 VACUTAINER Brand (PLUS) Plastic Blood Collection Tube with EDTA Anticoagulant and VACUTAINER Brand PLUS (Plastic) Serum Tube Regulatory Class: II Product Code: JKA Dated: March 17, 1998 March 18, 1998 Received:

Dear Ms. Schweighardt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use regulated by CDRH in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act The general controls provisions of the Act include (Act) . requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

In addition, we have determined that your indications for use which includes immunohematology testing for ABO grouping, Rh typing and antibody screening are subject to requlation by the Center for Biologics (CBER) .

Our substantially equivalent determination does not apply to the indications for use regulated by CBER. CBER is reviewing BK980011 for the immunohematology claims. For information on applicable Agency requirements for marketing this product, we suggest you contact:

Mary Gustafson HFM-370, Room 200 N. Woodmont Center for Biologics Evaluation and Research Food and Druq Administration, Rockville, MD 20852 (301) 827-3524

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal

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Page 2 - Ms. Schweighardt

Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.

In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device indicated for uses regulated by CDRH in your 510(k) premarket notification although we recommend that you first contact Ms. Kochman from CBER at (301) 827-3524 before marketing your product with the immunohematology claims regulated by CBER. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Dutra

Steven I. Gutman, MD, MBA Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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ATTACHMENT I

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Kg81013

Device Name: VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant and VACUTAINER® Brand PLUS Serum Tube

Indications for Use:

510(k) Number (if known):_

Blood collected in PLUS EDTA and PLUS Serum tubes can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮨﮯ Prescription Use_ OR (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Clare Sliva

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.