(135 days)
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.
Not Found
This document is a 510(k) premarket notification for a medical device, specifically a "S-Monovette EDTA K2-Gel" blood collection tube. It outlines the FDA's decision regarding substantial equivalence to a predicate device and provides information on the intended use of the device.
However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations of AI/ML-driven or diagnostic/screening devices for which the requested information (e.g., sample size for test set, number of experts, adjudication method, AI vs. human performance) would be relevant.
This document pertains to a blood specimen collection device, which is a Class II medical device. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness through comparisons of design, materials, performance, labeling, and intended use. Performance testing for a blood collection device would typically involve demonstrating its ability to properly collect, store, and process blood specimens according to its stated indications, and to ensure the blood components (e.g., plasma) are suitable for subsequent laboratory testing. This would involve chemical stability, sterility, and physical integrity studies rather than diagnostic accuracy studies with ground truth.
Therefore, I cannot extract the requested information (Table of acceptance criteria, sample size, expert qualifications, etc.) because it is not present in this type of FDA 510(k) summary for a blood collection device. The information requested is more relevant for diagnostic devices that analyze patient data to make a clinical determination.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 (828) 465-4000 Corporate
Telefax (828) 465-0718 Corporate
Phone (800) 257-5101 Sales
Telefax (828) 465-4003 Sales
§ 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.