S-MONOVETTE EDTA K2-GEL

• K Number: K031359
• Device Name: S-MONOVETTE EDTA K2-GEL
• Manufacturer: SARSTEDT, INC.
• Date Cleared: 2003-09-12 ( 135 days)
• Product Code: PJE
• Regulation Number: 862.1675

Intended Use

The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components. The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a blood collection tube and its intended use for plasma separation, with no mention of AI or ML technology.

Therapeutic

No.
The device is used for collecting, processing, and transporting plasma specimens for diagnostic testing, not for treating a disease or condition.

Diagnostic

No
The device is described as a collection, processing, and transportation system for plasma specimens. It prepares a sample for subsequent testing, but it does not perform the testing or provide a diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a physical blood collection tube with gel, which is a hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the S-Monovette® EDTA K2-Gel is not an IVD (In Vitro Diagnostic) device itself, but rather a component used in the process of preparing a specimen for IVD testing.

Here's why:

• Intended Use: The intended use describes the device's function in collecting, processing, and transporting a plasma specimen. It facilitates the separation of plasma from cellular components.
• Purpose of the Specimen: The plasma specimen produced by this device is then used for Nucleic Acid Testing (NAT) or other procedures. These tests (like PCR) are the actual IVD procedures that diagnose or provide information about a patient's health.
• Device Description (Not Found): While a full device description is missing, the intended use clearly focuses on specimen preparation, not on performing a diagnostic test itself.

Think of it like this: A test tube is used to hold a blood sample, but the test tube itself isn't the diagnostic device. The diagnostic device is the instrument or kit that analyzes the contents of the test tube to provide a diagnostic result.

The S-Monovette® EDTA K2-Gel is a specialized container and processing aid for preparing a sample that will then be used in an IVD test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

Product codes

PJE

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sarstedt, Inc. Mr. Peter Rumswinkel VP/General Manager P. O. Box 468 Newton, NC 28658-0468

FEB 0 6 2015

Re: K031359

Trade/Device Name: S-Monovette EDTA K2-Gel Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJE Dated: August 12, 2003 Received: August 13, 2003

Dear Mr. Rumswinkel:

This letter corrects our substantially equivalent letter of September 12, 2003.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kal Dunn

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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Sarstedt, Inc. • P.O. Box 468 • Newton, NC 28658-0468

Instruments and Disposables for Medicine and Science

Indications for Use Statement

Ko31359 510(k) Number:

Device Name: S-Monovette® EDTA K2-Gel

Indications For Use:

The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use _
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)

Division Sign-Off
for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

P.O. Box 468 Newton, NC 28658-0468

510k).

Phone [phone] Corporate
Telefax [phone] Corporate
Phone [phone] Sales
Telefax [phone] Sales