S-MONOVETTE EDTA K2-GEL

K031359 · Sarstedt, Inc. · PJE · Sep 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031359
• Device Name: S-MONOVETTE EDTA K2-GEL
• Applicant: Sarstedt, Inc.
• Product Code: PJE · Clinical Chemistry
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The S-Monovette® EDTA K₂-Gel tube 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 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 other procedures where the laboratory has determined that a plasma specimen is appropriate.

Device Story

S-Monovette EDTA K2-Gel is a closed-system blood collection device. It consists of a tube containing EDTA anticoagulant and a separation gel. During phlebotomy, blood is drawn directly into the tube. Post-collection, the device is centrifuged; the gel migrates to form a physical barrier between plasma and cellular components. This barrier allows for stable transport and storage of the plasma specimen, preventing re-mixing. The device is used in clinical or laboratory settings by healthcare professionals. The resulting plasma is suitable for downstream diagnostic applications, specifically Nucleic Acid Testing (NAT) and PCR, facilitating accurate clinical decision-making by ensuring specimen integrity during transport and processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic construction; EDTA K2 anticoagulant; acrylic/silicon gel separator. Available in 4.9 mL and 9.0 mL volumes. Vacuum or aspiration collection principle. Sterilization per ANSI/AAMI/ISO 11137. Complies with ISO 6710.

Indications for Use

Indicated for the collection, processing, and transport of human blood specimens to obtain plasma for laboratory testing, including Nucleic Acid Testing (NAT) and PCR-based procedures.

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.

Submission Summary (Full Text)

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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).

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