(68 days)
None
Not Found
No
The document describes quality control materials for a coagulation analyzer and does not mention any AI or ML components.
No
The device is described as a quality control product for a blood coagulation analyzer system, designed to verify the proper functioning of the analyzer and test cards, not to treat a medical condition.
No
The device described is a quality control product for an analyzer and test cards, not a diagnostic device itself. Its purpose is to ensure the accuracy of the analyzer system, not to diagnose medical conditions in patients.
No
The device description is not found, but the intended use clearly describes physical controls ("Rapidpoint Coaq HMP controls") used with a physical analyzer ("Rapidpoint Coag Analyzer") and physical test cards. This indicates a hardware component is central to the device's function.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the 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."
- Purpose of Quality Control: The controls are used to "indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of HMT. HTT. and PRT card results." This means they are used to assess the performance of a diagnostic system that analyzes biological samples (implied by the coagulation tests).
- In Vitro: The controls themselves are not applied to a living organism. They are used in vitro (in a test tube or similar environment) to evaluate the performance of the diagnostic system.
Therefore, the Rapidpoint Coaq HMP controls fit the definition of an IVD because they are reagents or materials used in vitro to assess the performance of a diagnostic system that analyzes biological samples.
N/A
Intended Use / 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.
Product codes
GGN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: 1-919-954-9932
- Contact: Peter Scott VP of Quality Assurance and Regulatory Affairs
- Date of Summary: November, 1999
.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
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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Page 2
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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
(Optional Format 3-10-98)