(146 days)
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No
The description details a standard enzyme immunoassay for quantitative determination of valproic acid. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for spectrophotometric measurements.
No.
The device is an in-vitro diagnostic assay for measuring valproic acid levels, not a device for treating a condition or disease.
Yes
The device quantitatively determines valproic acid levels in human serum or plasma, and these measurements are explicitly stated to be "used in the diagnosis and treatment of valproic acid overdose and in monitoring the levels of valproic acid to help ensure appropriate therapy," which are clear diagnostic applications.
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 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 valproic acid in human serum or plasma. It also mentions that these measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels to help ensure appropriate therapy. These are all hallmarks of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or monitoring.
- Device Description: The description details a laboratory test based on a homogeneous enzyme immunoassay technique performed on automated clinical chemistry analyzers. This further confirms that it is a test performed on biological samples outside of the body.
- Performance Studies: The performance studies evaluate characteristics relevant to the accuracy and reliability of a laboratory test, such as precision, lower detection limit, and method comparison.
Therefore, based on the provided information, the ONLINE TDM Valproic Acid assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements were used in the diagnosis and treatment of valproic acid overdose and in monitoring the levels of valproic acid to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LEG
Device Description
The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid 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 Valproic Acid reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of valproic acid (free and protein-bound) 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
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Input Imaging Modality
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Anatomical Site
Not Found
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
Not Found
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)
The Roche ONLINE TDM Valproic Acid 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 Valproic Acid assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Valproic Acid assay. The following table summarizes the precision and method comparison results.
NCCLS Precision, Within run:
Control 1: Mean (ug/ml) 33.3, SD (ug/ml) 0.69, CV% 2.1
Control 2: Mean (ug/ml) 74.9, SD (ug/ml) 1.42, CV% 1.9
Control 3: Mean (ug/ml) 107.8, SD (ug/ml) 2.11, CV% 2.0
NCCLS Precision, Total:
Control 1: Mean (ug/ml) 33.3, SD (ug/ml) 2.07, CV% 6.2
Control 2: Mean (ug/ml) 74.9, SD (ug/ml) 3.75, CV% 5.0
Control 3: Mean (ug/ml) 107.8, SD (ug/ml) 5.02, CV% 4.7
Method Comparison:
Linear Regression: ONLINE TDM Valproic acid Vs. COBAS FP Valproic acid
N=54, Range = 15.0 -132.1 ug/ml
y = 1.017 x - 0.053
r = 0.995
SD (md 95) = 4.801
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See summary of performance studies for precision (SD, CV%) and method comparison (N, Range, y=mx+b, r, SD (md 95)).
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
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
AUG – 8 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
Date Prepared: March 10, 2006 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ONLINE TDM Valproic Acid
Common name: Enzyme Immunoassay, Valproic acid
Classification name: Enzyme Immunoassay, Valproic acid |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Valproic Acid (K951595). |
Continued on next page
1
510(k) Summary, Continued
| 4) Device Description | The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid 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 Valproic Acid reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of valproic acid (free and protein-bound) 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 Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. |
Continued on next page
2
510(k) Summary, Continued
The Roche ONLINE TDM Valproic Acid assay is substantially equivalent to 6.) Comparison other products in commercial distribution intended for similar use. Most to the Predicate notably, it is substantially equivalent to the currently marketed Roche Device COBAS INTEGRA Valproic Acid (K951595).
The Roche ONLINE TDM Valproic Acid 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 Valproic Acid assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Valproic Acid assay. The following table summarizes the precision and method comparison results.
| Roche ONLINE TDM Valproic Acid | | | Roche COBAS FP Valproic Acid
(Predicate) | | | |
|--------------------------------|-------------------------------------------------------------------------------------------|-----------|---------------------------------------------|----------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,
Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 33.3 | 74.9 | 107.8 | 26.2 | 60.1 | 102.0 |
| SD (µg/ml) | 0.69 | 1.42 | 2.11 | 0.46 | 1.05 | 2.46 |
| CV% | 2.1 | 1.9 | 2.0 | 1.7 | 1.7 | 2.4 |
| NCCLS Precision,
Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 33.3 | 74.9 | 107.8 | 26.2 | 60.1 | 102.0 |
| SD (µg/ml) | 2.07 | 3.75 | 5.02 | 0.61 | 1.26 | 2.46 |
| CV% | 6.2 | 5.0 | 4.7 | 2.3 | 2.1 | 2.4 |
| Method
Comparison | Linear Regression: ONLINE TDM
Valproic acid Vs. COBAS FP Valproic acid | | | Linear Regression: COBAS FP Valproic
acid Vs. COBAS FARA II | | |
| | N=54, Range = 15.0 -132.1 µg/ml
y = 1.017 x - 0.053
r = 0.995
SD (md 95) = 4.801 | | | N=207, Range = 3.2 - =150 µg/ml
y=1.041x - 1.365
r=0.998 | | |
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics, Inc. 9115 Hague Road Indianapolis, IN 46250-0457
AUG - 8 2006
K060690 Trade/Device Name: ONLINE TDM Valproic Acid Regulation Number: 21 CFR§ 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG Dated: July 19, 2006 Received: July 20, 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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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
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
KOGGG 510(k) Number (if known):
Device Name: ONLINE TDM Valproic Acid
Indications For Use:
The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements muman serain of paintine were used in the diagnosis and treatement of valproic acid overdose and in monitoring the levels of valproic acid 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)
AC
Jivision Sign-Oil
Office of the Vitro Diagnostic Device Evaluation and Safety
060690
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