HEMORAM/AGGRAM ANALYZER

K050053 · Helena Laboratories · JPA · Jul 11, 2005 · Hematology

Device Facts

• Record ID: K050053
• Device Name: HEMORAM/AGGRAM ANALYZER
• Applicant: Helena Laboratories
• Product Code: JPA · Hematology
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients. 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. Ristocetin cofactor reagents are used to quantitate the von Willebrand factor activity.

Device Story

HemoRAM/AggRAM system performs platelet aggregation and Ristocetin cofactor testing. System comprises PC-based HemoRAM software and 4-channel AggRAM analyzer module. Input: platelet-rich plasma (PRP) samples in cuvettes. Operation: laser diode (650 nm) transmits light through sample; photo detector measures light transmission proportional to platelet count; analog signal digitized and processed by CPU. Software calculates slope and maximum percent aggregation; performs curve smoothing; monitors quality control via Westgard rules; generates Levey-Jennings charts. Used in clinical laboratory settings by technicians/clinicians. Output: quantitative aggregation/agglutination results, customized reports, and diagnostic data for hemostasis abnormalities and von Willebrand's disease. Results assist clinicians in diagnosing platelet function disorders and von Willebrand disease.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance testing consistent with the predicate device.

Technological Characteristics

4-channel optical aggregometer; laser diode (650 nm) light source; photo detector sensing. PC-based architecture running Windows 2000. Connectivity via serial port for LIS integration. Software-controlled automated sequence, curve smoothing, and Westgard rule-based QC monitoring. Semi-automated operation.

Indications for Use

Indicated for patients requiring platelet aggregation and Ristocetin cofactor testing to evaluate hemostasis abnormalities, identify abnormal platelet function, and diagnose von Willebrand's disease.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Platelet Aggregation Chromogenic Kinetic System-4 (PACKS-4) (K912201 & K921465)

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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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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