(19 days)
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No
The summary describes a standard enzyme immunoassay for quantitative determination of a drug metabolite. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an immunoassay for in vitro diagnostic use, meaning it measures substances in human samples to aid in diagnosis or monitoring, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma." This indicates its purpose is to aid in diagnosis or monitoring of a medical condition.
No
The device is an in vitro diagnostic (IVD) assay, which is a chemical or biological test performed on a sample (serum or plasma) and requires physical reagents and laboratory equipment, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide. Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore, simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving optimal procainamide therapy.
Product codes
LAN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
NOV 1 6 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, California 94086
Re: K983812
Trade Name: N-Acetylprocainamide (NAPA)Enzyme Immunoassay Requlatory Class: II Product Code: LAN Dated: October 26, 1998 Received: October 28, 1998
Dear Dr. Tsay:
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 Requlations, 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 requlation (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, "Misbrandinq by reference to premarket notification" (21 CFR 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 Putman
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
2
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
N-ACETYLPROCAINAMIDE ENZTME IMMUNOASSAY Device Name:
Indications For Use:
The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide. Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore, simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving optimal procainamide therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) '
1 Prescription Use -(Per 21 CFR 801.109)
OR
Over-The-Counter Use -
(Optional Format 1-2-96)
ision Sign-Off)
sion of Clinical Laborato
(k) Number K983812