(72 days)
Not Found
No
The description details a standard immunoassay method based on turbidimetry and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test for quantitative determination of N-acetylprocainamide, used in therapeutic drug monitoring, not for direct therapeutic intervention.
Yes
The device is explicitly stated to be an "in vitro diagnostic test" in the device description section and is used for "quantitative determination" in therapeutic drug monitoring, indicating its role in diagnosis.
No
The device description clearly states it is an in vitro diagnostic test consisting of prepackaged reagents in a flexible plastic cartridge for use on a clinical chemistry system. This involves physical components (reagents, cartridge) and a hardware system (Dimension® clinical chemistry system), making it a hardware-based device with associated software for operation and analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the method is used for the "quantitative determination of N-acetylprocainamide in serum or plasma." This is a test performed on biological samples taken from the body.
- Device Description: The "Device Description" section clearly states that the method is an "in vitro diagnostic test."
- Mechanism: The description of the method (homogenous particle-enhanced turbidimetric inhibition immunoassay) involves analyzing the properties of the sample outside of the body.
These points all align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used for the quantitative determination of N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.
Product codes (comma separated list FDA assigned to the subject device)
LAN
Device Description
The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® NAPA Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle N-acetylprocainamide conjugate and monoclonal N-acetylprocainamide specific antibody. Nacetylprocainamide present in the sample competes with N-acetylprocainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentrtion of N-acetyl procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
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)
Split-sample comparative performance was evaluated between the Dade Behring Dimension® NAPA Flex® method and the predicate aca® NAPA method.
Comparative Method: Dade Behring aca® NAPA test pack
Slope: 0.96
Intercept (ug/mL): -0.03
Correlation Coefficient: 0.993
n: 73
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.993
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.
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
OCT 3 1 2003
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 21 CFR 807.92.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | August 19, 2003 |
| Name of Product: | Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge
method |
| FDA Classification Name: | N-acetylprocainamide test system (21CFR§862.3320; 91LAR) |
| Predicate Device: | Dade Behring aca® NAPA analytical test pack (K833378) |
Device Description:
The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® NAPA Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle N-acetylprocainamide conjugate and monoclonal N-acetylprocainamide specific antibody. Nacetylprocainamide present in the sample competes with N-acetylprocainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentrtion of N-acetyl procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
Intended Use:
The Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used for the quantitative determination of N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.
Comparison to Predicate Device:
A summary of the features of the Dade Behring Dimension® NAPA Flex® reagent cartridge method and the predicate device, the Dade Behring aca® NAPA analytical test pack (K833378) is provided in the following chart:
1
| Dimension® NAPA Flex® cartridge | aca® NAPA analytical test pack | |
|---|---|---|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Assay Range | 0.5 - 30.0 ug/mL | 1.0 - 16.0 ug/mL |
| Sample size | 2 uL | 40 uL |
| Measurement | PETINIA turbidimetric rate 340 nm and 700nm | EMIT®1 colorimetric rate 340 nm |
1 Registered trademark of Syva Company, Dade Behring Inc.
Split-sample comparative performance was evaluated between the Dade Behring Dimension® NAPA Flex® method and the predicate aca® NAPA method and the results are summarized below:
| Comparative
Method | Slope | Intercept
(ug/mL) | Correlation
Coefficient | n |
|-------------------------------------|-------|----------------------|----------------------------|----|
| Dade Behring
aca® NAPA test pack | 0.96 | -0.03 | 0.993 | 73 |
Comments on Substantial Equivalence:
Both the Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method and the aca® NAPA analytical test pack method are homogenous immunoassays intended for the quantitative determination of N-acetylprocainamide in serum or plasma. Split-sample comparative data demonstrated good agreement (correlation) between the methods.
Conclusion:
The Dade Behring Dimension® N-acety|procainamide (NAPA) Flex® reagent cartridge method and the predicate Dade Behring aca® NAPA analytical test pack method (K833378) are substantially equivalent based on their intended use, design and comparison performance characteristics as described above.
Richard M. Vaught Regulatory Affairs and Compliance Manager August 19, 2003
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
OCT 3 1 2003
- boc and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community Bldg. 500. M.S. 514 P.O. Box 6101 Newark. DE 19714-6101
Re: K032564
Trade/Device Name: Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAN Dated: August 19, 2003 Received: August 20, 2003
Dear Mr. Vaught:
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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Device Name:
Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method
Indications for Use:
The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used to measure N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.
Rm Naught
Richard M. Vaught Regulatory Affairs and Compliance Manager
August 19, 2003
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alets
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K03 2564
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)