(182 days)
The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von Willebrand's disease. "Nibeoous" reagents are used to quantitate the von Willebrand factor activity.
AggRAM Analyzer
The provided text is a 510(k) clearance letter for the HemoRam/AggRAM Analyzer System and its indications for use. It does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, body, and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Helena Laboratories c/o Ms Patricia Franks 1530 Lindbergh Dr. P.O. Box 752 Beaumont, TX 77704
JUL 1 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K050053
K030055
Trade/Device Name: HemoRam/AggRAM Analyzer System Regulation Number: 21 CFR 864.5425 Regulation Name: System, multipurpose in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: January 6, 2005 Received: January 26, 2005
Dear Ms. Franks:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premailer is substantially equivalent (for the indications for referenced above and have decemined the ace need no as marketed in interstate commerce
use stated in the enclosure) to legally marketed predicate devents, or to dovines that use stated in the enclosure) to legally many than the Medical Device Amendments, or to devices that the prior to May 28, 1976, the chacinem and of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Prod. You may have been reclassified in accordatice with the provisions of the Act. The may.
Act (Act) that do not require approval of a premarket approval application Act. The general Act (Act) that do not require approval or a promatics appearal controls provisions of the general therefore, market the device, subject to the general some in registration, list in the text on confors provisions of the Networked requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) into exas consist regulations affecting your device can be may be subject to such adultional controls. "Extrang may of the 21, 2008. In addition, FDA may publish found in the Courserning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I'DA s Issualled on a sacominal supplies with other requirement of the Act of that FDA has made a decemination that your as the veing Federal agencies. You must comply with any Federal Statures and regulations administeried by teasistation and listing (21 CFR Part 807); all the Act s requirements, incruding, but novine mactice requirements as set forth in the quality labeling (21 CFR Part 801), good manazavi.and if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your activalence of your device to legally premarket nothication. THE PDA midnig of baosantal organization for your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, If you desire specific information advactising of your device, please contact the Office of In
or questions on the promotion and advertising of your a 1944 at 1944 to the sta of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vito Diagnostic Device Draiation and saies to premarket notification" (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the Art fr You may obtain other general information on your responsibilities under the Act from the You may obtain other general informations and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PJ Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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of
Page
K050053 510(k) Number (if known):
Device Name:
AggRAM Analyzer
Indications for Use:
The AggRaM Analyzer is a 4-channel aggregometer designed to perform
and and the many al Distancing cofactor testing on patients The AggRam And Ristocetin cofactor testing on patients
platelet aggregation and Ristocetion studies are Platelet aggregation studies are for hemostasis abnormalities . performed to quantitate platele response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the platelet function. The agoniae, Risease Ristocetin Cofactor
diagnosis of von Willebrand's disease Rillebrand factor diagnosis of von Willebrand a dreader. "Nibeoous"
reagents are used to quantitate the von Willebrand factor activity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050053
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.