(154 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay technique and standard analytical performance metrics, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) assay used to measure procainamide levels, which aids in diagnosis and treatment monitoring. It does not directly provide therapy or interact with the body to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy." This indicates its role in supporting medical diagnosis and treatment decisions.
No
The device description clearly states it is an "assay" and a "reagent kit" used on automated clinical chemistry analyzers. This indicates it is a chemical/biological product and not solely software.
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 assay is for the quantitative determination of procainamide in human serum or plasma. It also mentions that the measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels to help ensure proper therapy. These are all hallmarks of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details a laboratory assay that analyzes a biological sample (serum or plasma) using a chemical reaction (enzyme immunoassay) to measure a substance (procainamide). This process is performed outside of the living body, which is the definition of "in vitro".
- Performance Studies: The performance studies evaluate the assay's ability to accurately and reliably measure procainamide in human samples, further supporting its use as a diagnostic tool.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to analyze human biological samples for diagnostic and therapeutic monitoring purposes, fitting the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.
Product codes (comma separated list FDA assigned to the subject device)
LAR
Device Description
The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide 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 Procainamide reagent kits.
The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of procainamide in human serum or plasma. 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 Procainamide assay was evaluated for several performance characteristics including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Procainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Procainamide assay. The following table summarizes the precision and method comparison results.
NCCLS Precision, Within run (Control 1: Mean (ug/ml) 1.7, SD (ug/ml) 0.03, CV% 1.5; Control 2: Mean (ug/ml) 7.1, SD (ug/ml) 0.07, CV% 1.0; Control 3: Mean (ug/ml) 11.6, SD (ug/ml) 0.28, CV% 2.4).
NCCLS Precision, Total (Control 1: Mean (ug/ml) 1.7, SD (ug/ml) 0.04, CV% 2.6; Control 2: Mean (ug/ml) 7.1, SD (ug/ml) 0.27, CV% 3.8; Control 3: Mean (ug/ml) 11.6, SD (ug/ml) 1.08, CV% 9.3).
Method Comparison: Linear Regression: ONLINE TDM Procainamide Vs. COBAS FP Procainamide (N=51, Range = 0.3 -10.6 ug/ml, y = 1.01 x + 0.25, r = 0.998, SD (md 95) = 0.311).
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
K 060773
AUG 2 3 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 Procainamide
Common name: Enzyme Immunoassay, Procainamide
Classification name: Enzyme Immunoassay, Procainamide |
| 3) Predicate
device | We claim substantial equivalence to the currently marketed COBAS
INTEGRA Procainamide(K951595). |
Continued on next page
.
1
510(k) Summary, Continued
| 4) Device
Description | The ONLINE TDM Procainamide assay is for the quantitative determination
of procainamide 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 Procainamide reagent kits. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assay is based on a homogeneous enzyme immunoassay technique used
for the quantitative analysis of procainamide in human serum or plasma. 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. |
| 5.) Intended
Use | The ONLINE TDM Procainamide assay is for the quantitative determination
of procainamide in human serum or plasma on Roche automated clinical
chemistry analyzers.
Measurements are used in the diagnosis and treatment of procainamide
overdose and in monitoring levels of procainamide to ensure proper therapy. |
| | Continued on next page |
:
2
510(k) Summary, Continued
6.) Comparison The Roche ONLINE TDM Procainamide assay is substantially equivalent to to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Procainamide (K951595).
The Roche ONLINE TDM Procainamide assay was evaluated for several performance characteristics including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptableresults compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Procainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Procainamideassay. The following table summarizes the precision and method comparison results.
| | | Roche ONLINE TDM N-
acetylprocainamide | | | Roche COBAS FP
Procainamide(Predicate) | | |
|----------------------|--|---------------------------------------------------------------------------------------|-----------|-----------|---------------------------------------------------------------|-----------|-----------|
| NCCLS Precision, | | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Within run | | | | | | | |
| Mean (µg/ml) | | 1.7 | 7.1 | 11.6 | 1.6 | 6.1 | 8.5 |
| SD (µg/ml) | | 0.03 | 0.07 | 0.28 | 0.05 | 0.13 | 0.21 |
| CV% | | 1.5 | 1.0 | 2.4 | 3.3 | 2.1 | 2.5 |
| NCCLS Precision, | | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Total | | | | | | | |
| Mean (µg/ml) | | 1.7 | 7.1 | 11.6 | 1.6 | 6.1 | 8.5 |
| SD (µg/ml) | | 0.04 | 0.27 | 1.08 | 0.05 | 0.15 | 0.22 |
| CV% | | 2.6 | 3.8 | 9.3 | 3.3 | 2.4 | 2.6 |
| Method
Comparison | | Linear Regression: ONLINE TDM
Procainamide Vs. COBAS FP
Procainamide | | | Linear Regression: COBAS FP
Procainamide Vs. COBAS FARA II | | |
| | | N=51, Range = 0.3 -10.6 µg/ml
y = 1.01 x + 0.25
r = 0.998
SD (md 95) = 0.311 | | | N=156, Range = 0.13 - 16 µg/ml
y=0.944x +0.20
r=0.996 | | |
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 features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG 23 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, In 46250
Re: K060773
Trade/Device Name: ONLINE TDM Procainamide Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAR Dated: July 27, 2006 Received: July 28, 2006
Dear Mr. Demirtzoglou:
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).
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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 (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 G. A.
Alberto Gutierrez, 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): K060773
Device Name: ONLINE TDM Procainamide
Indications For Use:
The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper 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)
Division S
Page 1 of
Office of In Vitro Diagnostic Device Evelur tion and Safery
KD60773