(33 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring drug levels and does not mention any AI/ML components or methodologies.
No
This device is an in vitro diagnostic (IVD) method used to measure levels of n-acetylprocainamide in human serum or plasma to aid in diagnosis and treatment monitoring, not to provide therapy itself.
Yes
The intended use explicitly states that "Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose." This indicates a diagnostic purpose.
No
The device is an in vitro diagnostic assay intended for use on a specific hardware system (Bayer Immuno-1 system), indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that this is an "in vitro method" intended to measure a substance (n-acetylprocainamide) in human serum or plasma. This is a key characteristic of an IVD, as it involves testing samples taken from the human body outside of the body.
- Purpose: The intended use also describes how the measurements are used: "in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions, which is the core function of an IVD.
- Sample Type: The device analyzes "human serum or plasma," which are biological samples commonly used in IVD testing.
- Method: It uses the "Syva EMIT® N-Acetylprocainamide Assay," which is a type of immunoassay, a common method employed in IVD testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.
This in vitro diagnostic procedure is intended to quantitatively measure N-acetylprocainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno I™ system. Measurements of N-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of N-acetylprocainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
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
Not Found
Anatomical Site
human serum or plasma (lithium heparin)
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the performance between the Immuno 1 N-Acetylprocainamide (NAPA) assay and a Elsstor of a confed is a confed clearance of substantial equivalence (Syva EMIT® N-Acetylprocainamide Assay, Behring Diagnostics Inc.).
Key Results:
Minimum Detectable Conc. (Immuno 1 NAPA Assay): 0.11 µg/mL
Minimum Detectable Conc. (Syva EMIT® NAPA Assay): 0.25 µg/mL
Precision (Immuno 1 NAPA Assay) (Total): 5.5% @ 1.7 µg/mL; 4.3% @ 4.2 µg/mL; 6.5% @ 8.7 µg/mL
Precision (Syva EMIT® NAPA Assay) (Between-Run): 3.9% @ 1.7 µg/mL; 4.5% @ 4.5 µg/mL; 4.5% @ 10.8 µg/mL
Correlation (Immuno 1 NAPA Assay vs. Syva EMIT® NAPA Assay): y = 0.99x - 0.03 where y = Immuno 1 N-Acetylprocainamide Assay, x = Syva EMIT® N-Acetylprocainamide Assay*, n = 99, r = 0.99, Syx = 0.29 µg/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Detectable Conc., Precision, Correlation
Predicate Device(s)
Syva EMIT® N-Acetylprocainamide Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SUMMARY OF SAFETY AND EFFECTIVENESS
N-Acetylprocainamide Assay for Bayer Immuno 1° System
Listed below is a comparison of the performance between the Immuno 1 N-Acetylprocainamide (NAPA) assay and a Elsstor of a confed is a confed clearance of substantial equivalence (Syva EMIT® N-Acetylprocainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno I N-Acetylorocainamide Method Sheet and the Syva EMIT® N-Acetylprocainamide Assay Insert Sheet.
INTENDED USED
This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.
| METHOD | Immuno 1 NAPA Assay | Syva EMIT® NAPA Assay
(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Part No. | T01-3990-51 | 4N024UL |
| Minimum Detectable Conc. | 0.11 µg/mL | 0.25 µg/mL |
| Precision | (Total)
5.5% @ 1.7 µg/mL
4.3% @ 4.2 µg/mL
6.5% @ 8.7 µg/mL | (Between-Run)
3.9% @ 1.7 µg/mL
4.5% @ 4.5 µg/mL
4.5% @ 10.8 µg/mL |
| Correlation | y = 0.99x - 0.03
where
y = Immuno 1 N-Acetylprocainamide Assay
x = Syva EMIT® N-Acetylprocainamide Assay*
n = 99
r = 0.99
Syx = 0.29 µg/mL | |
*This assay was performed on COBAS FARA II" Instrument using parameters and protocol specified in Behring Application Sheet.
Gabriel J. Murray, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
ﺳﮯ
5/7/97
Date
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting a sense of movement and connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 111 1997
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
K971713 Re :
N-Acetylprocainamide Assay for the Bayer Immuno 1™ System 发 Regulatory Class: II Product Code: LAN Dated: May 7, 1997 Received: May 9, 1997
Dear Mr. Muraca:
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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.
2
Paqe 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 diaqnostic 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" (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/dsmamain.html".
Sincerely yours,
Steven Sitman
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
3
Page 1 of 1
510(k) Number (if known):
N-Acetylprocainamide (NAPA) Device Name:_
Indications For Use:
This in vitro diagnostic procedure is intended to quantitatively measure N-acetylprocainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno I™ system. Measurements of N-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of N-acetylprocainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
T WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K171713 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |