HMP CONTROLS (TAS) RAPIDPOINT

K994159 · Cardiovascular Diagnostics, Inc. · GGN · Feb 15, 2000 · Hematology

Device Facts

• Record ID: K994159
• Device Name: HMP CONTROLS (TAS) RAPIDPOINT
• Applicant: Cardiovascular Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: Feb 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The new Rapidpoint Coaq HMP controls are intended to be used exclusively with the Rapidpoint Coag Analyzer and the Rapidpoint Coag Heparin Management Test (HMT), Heparin Titration Test (HTT), and Protamine Response Test (PRT) cards to provide a method for quality control of the system. The controls produce clotting times that must be within accepted, standard ranges, when tested at CVDI before release of product for sale, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results.

Device Story

Rapidpoint Coag HMP Controls are quality control materials used with the Rapidpoint Coag Analyzer and associated test cards (HMT, HTT, PRT). The controls consist of samples with known clotting time ranges; they are processed by the analyzer to verify system performance. By confirming that the analyzer and test cards produce results within established standard ranges, the controls ensure the accuracy of clinical coagulation testing. Used in clinical settings by laboratory professionals to validate system integrity before patient testing. The device provides a mechanism for routine quality assurance, reducing the risk of erroneous clinical decisions based on inaccurate coagulation measurements.

Clinical Evidence

No clinical data. Bench testing only; controls are validated by comparing measured clotting times against established standard ranges to ensure system performance.

Technological Characteristics

In vitro diagnostic quality control material. Liquid or lyophilized control samples designed for use with the Rapidpoint Coag Analyzer. Operates as a reference standard to verify system calibration and functionality. No electronic components or software algorithms; purely a chemical/biological control reagent.

Indications for Use

Indicated for quality control of the Rapidpoint Coag Analyzer system, including Heparin Management Test (HMT), Heparin Titration Test (HTT), and Protamine Response Test (PRT) cards. Used by clinical laboratory personnel to verify proper system function and ensure accuracy of coagulation test results.

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.

Submission Summary (Full Text)

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Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 November 1999

## 510(k) Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

The assigned 510(k) number is 1994159

- Cynthia Pritchard, Ph.D. Submitted by: Executive Director of Test Development
- Cardiovascular Diagnostic, Inc. Address: 5301 Departure Drive Raleigh, NC 27616

1-800-247-4234 Phone:

Fax: [phone]

- Contact: Peter Scott VP of Quality Assurance and Regulatory Affairs
- Date of Summary: November, 1999

.

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FEB 1 5 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Peter Scott Vice President, Ouality Assurance and Regulatory Affairs Cardiovascular Diagnostic, Inc. 5301 Departure Drive Raleigh, North Carolina 27616

Re: K994159

Trade Name: Rapidpoint™ Coag Heparin Management Panel Controls (HMP Controls) Regulatory Class: II Product Code: GGN Dated: February 2, 2000 Received: February 8, 2000

Dear Mr. Scott:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K9941159

Device Name: Rapidpoint™ Coag Heparin Management Panel (HMP) Controls

Indications For Use:

The new Rapidpoint Coaq HMP controls are intended to be used exclusively with the Rapidpoint Coag Analyzer and the Rapidpoint Coag Heparin Management Test (HMT), Heparin Titration Test (HTT), and Protamine Response Test (PRT) cards to provide a method for quality control of the system. The controls produce clotting times that must be within accepted, standard ranges, when tested at CVDI before release of product for sale, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Letle Mayhem
(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K094159

Prescription Y

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