(149 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay technique and standard statistical analysis, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used to measure the concentration of N-acetylprocainamide in human serum or plasma. It provides information for diagnosis and monitoring, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained from this device are used in the diagnosis and treatement of N-acetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy." This directly indicates its role in diagnosis.
No
The device description clearly states it is an "assay" and a "reagent kit" used on automated clinical chemistry analyzers, indicating it is a chemical/biological product and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "quantitative determination of N-acetylprocainamide in human serum or plasma". It also mentions that the measurements are used "in the diagnosis and treatment of N-acetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy." This clearly indicates that the device is used to examine specimens derived from the human body (serum or plasma) to provide information for diagnostic and therapeutic purposes.
- Device Description: The description details a "homogeneous enzyme immunoassay technique used for the quantitative analysis of N-acetylprocainamide in human serum or plasma." This further confirms that the device is designed to perform tests on human biological samples.
- Performance Studies: The performance studies evaluate the device's ability to accurately measure N-acetylprocainamide in human samples, comparing it to a predicate device that is also an IVD (K951595; COBAS INTEGRA N-acetylprocainamide).
Based on 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 determine the safety and compatibility of any tissue or organ for transplantation, or to monitor therapeutic measures, this device fits the criteria.
N/A
Intended Use / Indications for Use
The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of Nacetylprocainamide in human serum or plasma on Roche automated clinical chemistry I nalyzers. Measurements obtained from this device are used in the diagnosis and treatement of Nacetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.
Product codes
LAN
Device Description
The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of N-acetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM N-acetylprocainamide reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of N-acetylprocainamide in human serum or plasma.[6,7] The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.
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)
The Roche ONLINE TDM N-acetylprocainamide assay was evaluated for several performance characteristics including precision, lower detection limit, specificity, and interfering substances. All of the method comparisons, and acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM N-acetylprocainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA N-acetylprocainamide assay.
NCCLS Precision, Within run:
Control 1: Mean (ug/ml) = 1.7, SD (ug/ml) = 0.07, CV% = 3.9
Control 2: Mean (ug/ml) = 4.0, SD (ug/ml) = 0.08, CV% = 2.0
Control 3: Mean (ug/ml) = 8.2, SD (ug/ml) = 0.17, CV% = 2.1
NCCLS Precision, Total:
Control 1: Mean (ug/ml) = 1.7, SD (ug/ml) = 0.08, CV% = 5.0
Control 2: Mean (ug/ml) = 4.0, SD (ug/ml) = 0.16, CV% = 4.0
Control 3: Mean (ug/ml) = 8.2, SD (ug/ml) = 0.26, CV% = 3.2
Method Comparison: Linear Regression: ONLINE TDM N-acetylprocainamide Vs. COBAS FP N-acetylprocainamide
N=54, Range = 0.5 -16.3 ug/ml
y = 1.03 x + 0.09
r = 0.995
SD (md 95) = 0.389
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
AUG 16 2006
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information |
| provides sufficient detail to understand the basis for a determination of | |
| substantial equivalence. | |
| 1) Submitter | |
| name, address, | |
| contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7688 | |
| Contact Person: Dimitris Demirtzoglou | |
| 2) Device name | Proprietary name: ONLINE TDM N-acetylprocainamide |
| Common name: Enzyme Immunoassay, N-acetylprocainamide | |
| Classification name: Enzyme Immunoassay, N-acetylprocainamide | |
| 3) Predicate | |
| device | We claim substantial equivalence to the currently marketed COBAS |
| INTEGRA N-acetylprocainamide (K951595). | |
| Continued on next page |
1
510(k) Summary, Continued
The ONLINE TDM N-acetylprocainamide assay is for the quantitative 4) Device determination of N-acetylprocainamide in human serum or plasma on Description Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM N-acetylprocainamide reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of N-acetylprocainamide in human serum or plasma.6,7 The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay. The ONLINE TDM N-acetylprocainamide assay is for the quantitative 5.) Intended determination of N-acetylprocainamide in human serum or plasma on Use Roche automated clinical chemistry analyzers. N-acetylprocainamide measurements are used in monitoring levels of N-acetylprocainamide to ensure procainamide therapy. Continued on next page
R
2
510(k) Summary, Continued
The Roche ONLINE TDM N-acetylprocainamide assay is substantially 6.) Comparison equivalent to other products in commercial distribution intended for similar to the Predicate equivalent to other products is substantially equivalent to the currently marketed Device Roche COBAS INTEGRA N-acetylprocainamide (K951595).
The Roche ONLINE TDM N-acetylprocainamide assay was evaluated for The Roone Order Order istics including precision, lower detection limit, several performance onarecificity, and interfering substances. All of the mentod comparisons, and acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM N-These "experiments" provise "ubstantially equivalent to the currently marketed Roche COBAS INTEGRA N-acetylprocainamide assay. The following table summarizes the precision and method comparison results.
| | Roche ONLINE TDM N-
acetylprocainamide | | | Roche COBAS FP N-
acetylprocainamide (Predicate) | | |
|--------------------------------|----------------------------------------------------------------------------------------------|-----------|-----------|------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,
Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 1.7 | 4.0 | 8.2 | 5.4 | 11.5 | 20.9 |
| SD (µg/ml) | 0.07 | 0.08 | 0.17 | 0.09 | 0.18 | 0.60 |
| CV% | 3.9 | 2.0 | 2.1 | 1.6 | 1.6 | 2.9 |
| NCCLS Precision,
Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 1.7 | 4.0 | 8.2 | 5.4 | 11.5 | 20.9 |
| SD (µg/ml) | 0.08 | 0.16 | 0.26 | 0.15 | 0.27 | 0.68 |
| CV% | 5.0 | 4.0 | 3.2 | 2.8 | 2.3 | 3.2 |
| Method
Comparison | Linear Regression: ONLINE TDM N-
acetylprocainamide Vs. COBAS FP N-
acetylprocainamide | | | Linear Regression: COBAS FP N-
acetylprocainamide Vs. COBAS FARA II | | |
| | N=54, Range = 0.5 -16.3 µg/ml
y = $1.03 x + 0.09$
r = 0.995
SD (md 95) = 0.389 | | | N=153, Range = 0.5 - 29 µg/ml
y= $0.978x +0.059$
r=0.997 | | |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2006
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Operations, Inc. 9115 Hague Road Indianapolis, IN 46250
K060738 Re:
K000738
Trade/Device Name: ONLINE TDM N-acetylprocainamide Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAN Dated: July 20, 2006 Received: July 24, 2006
Dear: Mr. Demirtzoglou
We have reviewed your Section 510(k) premarket not intent to market the device We have reviewed your Section 510(x) promution is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to tegally manced te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Regisions of the Federal Fo commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, lighten of You may, therefore, market the ucvice, subject to the gents for annual registration, listing of
general controls provisions of the Act include requires withings apping misbra general controls provisions of the Act mende requirements of the security misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (see adove) into enter regulations affecting your device
it may be subject to such additional controls. it may be subject to such additional comions. Existing mayor regals 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Farse Register can be found in Title 21, Couc of I ederal regarations (1 - 177)
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 Please be advised that FDA s issualited of a substition with other requirements of the Act
that FDA has made a determination that your device address . You must that FDA has made a delemination that your derres sompler Federal agencies. You must or any Federal statures and regulations administers of existiration and listing (21
comply with all the Act's requirements, including, but not most consection comply with an the Act s requirements, moraaling, or and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 800 CFR Part 807), labeling (21 CFR Parts 60 Parts (QS) regulation (21 CFR Part 820).
4
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, nr questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: ONLINE TDM N-acetylprocainamide
Indications For Use:
The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of Nacetylprocainamide in human serum or plasma on Roche automated clinical chemistry I nalyzers. Measurements obtained from this device are used in the diagnosis and treatement of Nacetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jivision Sign-Off
Office of In Vita Diagnostic Device Evaluation and Safety
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