PRENVAL I
Device Facts
| Record ID | K953652 |
|---|---|
| Device Name | PRENVAL I |
| Applicant | Base Ten Systems, Inc. |
| Product Code | JQP · Clinical Chemistry |
| Decision Date | Sep 15, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2100 |
| Device Class | Class 1 |
Device Story
The PRENVAL™ I is a calculator/data processing module for clinical use. It functions as a computational tool for processing clinical data. The device is intended for use by healthcare professionals in clinical settings to assist in data management and calculation tasks. It operates by receiving clinical inputs and performing programmed calculations to provide outputs that support clinical decision-making.
Clinical Evidence
No clinical data provided; device is a Class I calculator/data processing module.
Technological Characteristics
Calculator/data processing module for clinical use; Class I; Product Code JQP; 21 CFR 862.2100.
Regulatory Classification
Identification
A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
Submission Summary (Full Text)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
APR 23 2009
Mr. Richard J. Farrelly
Vice President
Base Ten Systems, Inc.
One Electronics Drive
P.O. Box 3151
Trenton, NJ 08619
Re: k953652
Trade/Device Name: PRENVAL™ I
Regulation Number: 21 CFR 862.2100
Regulation Name: Calculator/data processing module for clinical use
Regulatory Class: I
Product Code: JQP
Dated: April 27, 1993
Received: April 28, 1993
Dear Mr. Farrelly:
This letter corrects our substantially equivalent letter of September 15, 1995.
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 (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.
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
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Page 2 – Mr. Richard J. Farrelly
requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 Part 801), please contact the Division of Immunology and Hematology Devices at 240-276-0493. Also, please note 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Chan
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
