(49 days)
Not Found
Not Found
No
The summary describes a standard immunoassay technique (EMIT) for measuring drug levels, with no mention of AI or ML terms, image processing, or data training/testing.
No
This device is an in vitro diagnostic procedure designed to measure drug levels, which aids in diagnosis and monitoring therapy, but it does not directly administer therapy or treat a condition itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "This in vitro diagnostic procedure is intended to quantitatively measure procainamide... Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy." This text clearly identifies the device's diagnostic purpose.
No
The device is an in vitro diagnostic procedure that uses a specific assay and system (Bayer Immuno 17M/19) to measure a substance in biological samples. This involves physical reagents and hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that it is an "in vitro diagnostic procedure" and an "in vitro method" intended to measure procainamide in human serum or plasma. This aligns directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.
This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
Product codes (comma separated list FDA assigned to the subject device)
LAR
Device Description
Not Found
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
Not Found
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)
Comparison of the performance between the Immuno 1 Procainamide assay and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Procainamide Assay, Behring Diagnostics Inc.).
- Minimum Detectable Conc.: 0.53 µg/mL
- Precision (Total): 3.1% @ 2.0 µg/mL, 4.1% @ 7.6 µg/mL, 7.0% @ 9.4 µg/mL
- Correlation: y = 0.95x + 0.24, where y = Immuno 1 Procainamide Assay, x = Syva EMIT® Procainamide Assay*, n = 99, r = 0.99, Syx = 0.27 µg/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Detectable Conc.: 0.53 µg/mL
Precision (Total): 3.1% @ 2.0 µg/mL, 4.1% @ 7.6 µg/mL, 7.0% @ 9.4 µg/mL
n = 99, r = 0.99, Syx = 0.27 µg/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains a handwritten sequence of characters that appears to be "K971716" with a line drawn underneath. The characters are written in a bold, somewhat stylized manner, with some of the numbers having a slightly rounded appearance. The line underneath the sequence emphasizes the characters.
JUN 27 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
Procainamide Assay for Bayer Immuno 1 System
Listed below is a comparison of the performance between the Immuno 1 Procainamide assay and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Procainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Procainanide Method Sheet and the Syva EMIT® Procainamide Assay Insert Sheet.
INTENDED USED
This in viro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.
| METHOD | Immuno 1 Procainamide Assay | Syva EMIT® Procainamide Assay
(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Part No. | T01-3988-51 | 4K024UL |
| Minimum Detectable Conc. | 0.53 µg/mL | 0.25 µg/mL |
| Precision | (Total)
3.1% @ 2.0 µg/mL
4.1% @ 7.6 µg/mL
7.0% @ 9.4 µg/mL | (Between-Run)
2.5% @ 2.4 µg/mL
3.0% @ 5.7 µg/mL
4.2% @ 9.7 µg/mL |
| Correlation | y = 0.95x + 0.24
where
y = Immuno 1 Procainamide Assay
x = Syva EMIT® Procainamide Assay*
n = 99
r = 0.99
Syx = 0.27 µg/mL | |
*This assay was performed on COBAS FARA II® Instrument using parameters and protocol specified in Behring Application Sheet.
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
5/7/97
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 27 1997
Gabriel J. Muraca, Jr. Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Re : K971716 Procainamide Assay for the Bayer Immuno 1™ System Requlatory Class: II Product Code: LAR 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 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 requirement, 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 requlatory In addition, FDA may publish further announcements action. 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
Page 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 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" (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 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
3
Page 1 of 1
510(k) Number (if known):
Procainamide (PROC) Device Name:
Indications For Use:
This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory | |
| 510(k) Number | K971716 |
| Prescription Use: (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |