VACUTAINER BRAND PPT PLASMA PREPARATION TUBE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a graphic with the number 100 in a stylized font, partially obscured by a globe illustration. Above the number, the text "K972075" is visible, stamped across the top of the image. Additionally, the date "FEB 24 1998" is stamped above the text "K972075". The overall impression is that of an official document or record with a combination of numerical and textual elements. CELEBRATING THE FIRST ONE HUNDRED: 1897-1997 Image /page/0/Picture/2 description: The image shows the logo for Becton Dickinson. The logo is in a bold, sans-serif font. The words "BECTON" and "DICKINSON" are stacked on top of each other. The logo is in black and white. Becton Dickinson and Company 1 Becton Drive Franklin Lakes, New Jersey 07417 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS. 800 ## General Information ﻨﺴ l. General Information This Summary of 510(k) Safety and Effectiveness information is being submitted This Summary of STO(K) Salety and Lifestivents of 1990 and 21 CFR 807.92 ## Establishment: - · Address: Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885 - · Registration Number: - 2243072 - · Contact Person: John A. Schalago Regulatory Affairs Specialist Telephone no .: 201 - 847 - 6280 Facsimile no .: 201 - 847 - 4858 · Date of Summary: December 4, 1997 Device Name: - VACUTAINER® Brand PPT™-Plasma Preparation Tube · Trade Name: - · Classification Name : Blood Specimen Collection Device - Class II · Classification: - None Established under 514 of · Performance Standards: the Food, Drug and Cosmetic Act - Safety and Effectiveness Information Supporting the Substantial 0 Equivalence Determination The term, "Substantial Equivalence" 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 approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution {1}------------------------------------------------ of patent infringement suits or any other patent matters. No statements related of patent ininingement outle of any othere herein shall be construed as an to of in Support of Substantial OquivalUnce Horsin Swent Laws or their application by the courts. - · Device Description The VACUTAINER® Brand PPT™-Plasma Preparation Tube (blood collection The VACOTAINER® Brand Property is an evacuated plastic tube containing EDTA Antiocagana, processing and transporting blood in a blood obliobiler Rabe for Selleum NER® Brand PPT™ consists of a Closed plastic tube. The VAOS v. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (dipotassium or tripotassium) and a polymeric gel barrier material. - · Intended Use ar The VACUTAINER® Brand PPT™ Plasma Preparation Tube with EDTA The VACUTAINER® Diana . . . anticoagulant and a gel barrier material are evacuated blood collection tubest in a anticoagulant and a gol banner ting, processing and transporting blood in a which provide a mound of other is used together with VACUTAINER® Closed plastic tube. "There it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing EDTA anticoagulant and gel barrier material is used primarily to provide undiluted plasma for use in molecular material is used primarily to proving but not limited to PCR (Polymerase Chain diagnostic tool morrous included DNA). The specimen may also be used for reaction) and bDNA (Dranches an undiluted plasma sample as determined by the laboratory. • Synopsis of Test Methods and Results Six studies were conducted to evaluate the use of the VACUTAINER® Brand On cludios for molecular diagnostic viral load determinations. Study I evaluated the clinical functional performance of the PPT™ tube as compared evaluatou the chillion franco Venoject KsEDTA). Studies II, III, IV, V, and VI were conducted to demonstrate substantial equivalence to the predicate device (PLUS K2 EDTA). Studies I, III, and IV compared HIV viral loads obtained with the principal device to viral loads obtained with either control or predicate (non-gel separator EDTA) devices. Studies II, V, and VI compared products (non-gol open in the principal device to those obtained in the predicate device. {2}------------------------------------------------ The clinical functional performance of the VACUTAINER® PPT™ Tube was The cilineal functional portenments on INV RT PCR Monitor™ Kit. (Study I) evaluation compared the VACUTAINER® PPT™ Tube, principal The Clinical Gvaluation Compared the 1.00 to 56 HIV-Positive patients. Paired aliquots of undiluted plasma produced in the VACUTAINER® PPT™ tube and aliquots of unundiou processor for HIV viral load. The PPT™ tube Terumb vollojoo. IS LD Projected performance compared to the samples produced in the EDTA control tube. Substantial equivalence between the principal device and the predicate Substantial equivalories Brand PLUS EDTA) was demonstrated for the device (9758 17 ... .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitor™ Test Kit, (Studies III and IV), the Amplicor® HCV RT PCR Monitor - Tost Kit (Studies V and VI), and for the Chiron Quantiplex HCV-RNA (branched DNA) assay (Study II). Two HIV clinical evaluations (Study III and Study IV) compared viral load TWo first of paired PPT ™/EDTA samples from HIV positive subjects. measuremorne of pail the viral load of plasma produced from forty (40) HIV positive subjects. The samples were evaluated using the Roche Amplicor® HIV RT PCR Monitor™ Kit. The results of HIV viral load determinations demonstrated statistically and clinically equivalent results between the principal and predicate devices. The VACUTAINER® Brand PPT™ Tube was also evaluated for HCV viral load determinations, by b-DNA and PCR. For Study II, a total of forty-nine (49) paired samples were collected from twenty-four (24) HCV negative and twenty-five (25) HCV positive subjects and evaluated using the Chiron Quantiplex HCV RNA Assay. The VACUTAINER® Brand PPT™ Tube, principal device, demonstrated equivalent results to the VACUTAINER® Brand PLUS Tube with EDTA for both negative and positive HCV samples. For Studies V and VI, paired PPT™/EDTA samples were collected from a total of sixty-five (65) HCV-positive patients and were evaluated for HCV viral load using the Roche Amplicor® HCV RT PCR Monitor™ Test Kit. Viral load measurements of paired HCV samples were compared and results indicated that viral load results obtained from plasma produced in the VACUTAINER® Brand PPT™ Tube are equivalent to those obtained with the VACUTAINER® Brand PLUS Tube with EDTA. ر ۽ {3}------------------------------------------------ - · Substantial Equivalence Becton Dickinson VACUTAINER Systems believes that the VACUTAINER® Becon Dicklifson VAOOTAINER ogenivalent to two commercially available Brand PPT™ Tube is substantially equivalent to two couivalent Bland PP T --- Tube is Substantially oquitely demonstrated equivalent Diod Collection tubos: "Official tool comparisons of the Principal and penormance and ensctiveness and compulacturing process supports the Predicate device onlaracements una nee. The predicate devices, determination of oubotantial oclearance date are identified below: | Manufacturer | Predicate Device | K-Number | Clearance<br>Date | |--------------------|--------------------------------------------------------|----------|-------------------| | VACUTAINER Systems | VACUTAINER® Brand PLUS Tube with<br>EDTA Anticoagulant | K953463 | 9/20/95 | | VACUTAINER Systems | VACUTAINER™ Brand PST™ Tube | K945952 | 1/18/95 | Joska Abelaigor ohn A. Schalago Regulatory Affairs Specialist Regulatory Affairs Department December 4, 1997 Date {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Becton Dickinson Vacutainer Systems and Labware John A. Schalago Regulatory Affairs Specialist 1 Beckton Drive Franklin Lakes, NJ 07417 FEB 0 6 2015 Re: K972075 Trade/Device Name: VACUTAINER Brand PPT Plasma Preparation Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJE Dated: December 4, 1997 Received: December 5, 1997 Dear Mr. Schalago: This letter corrects our substantially equivalent letter of February 24, 1998. 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 or any Federal statutes and regulations administered by other Federal agencies. You must {5}------------------------------------------------ Page 2 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 Also, please note http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.lda.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours, 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 {6}------------------------------------------------ 510(k) Number (if known): 1972075 Device Name: VACUTAINBR® Brand PPT™ Plasma Preparation Tubes Indications for Use: The VACUTAINER® Brand PPT™ Plasma Preparation Tube with HDTA anticoagulant and a gel barrier material are evacuated blood collection which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is .. used together with VACUPAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing HDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched-DNA (bDNA). The specimen may also be used for other testing that requires an undiluted plasma sample as determined by the laboratory. | (Division Sign-Off<br>Division of Clinical Laboratory Devices | | |---------------------------------------------------------------|----------| | 510(k) Number | k9912675 | ## (PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED) :: Concurrence of CDRH, Office of Device Evaluation (ODB) Prescription Use v OR Over-the-Counter Use (Per 21 CFR 801 : 109) (Optional Format 1-2-96)