(51 days)
Not Found
No
The device description details a homogeneous immunoassay based on chemical reactions and light/absorbance measurements, with no mention of AI or ML in the technology or performance evaluation.
No
The device is an in vitro diagnostic reagent system used for quantitative determination of valproic acid in human serum or plasma. It is used to monitor drug levels, not to treat a condition.
Yes
The device is an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma, which is used to assist in the treatment of seizures. This falls under the definition of a diagnostic device as it provides information for the diagnosis or treatment of a condition.
No
The device description clearly outlines a reagent system and its interaction with automated clinical chemistry analyzers, indicating a physical, in vitro diagnostic product, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma..."
This statement clearly identifies the device as an in vitro diagnostic reagent system, which is a key characteristic of an IVD.
N/A
Intended Use / Indications for Use
For the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit mal seizures and other generalized and partial complex seizures.
Product codes
LEG
Device Description
The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with valproic acid and rapidly aggregate in the presence of a valproic acid antibody solution. When a sample containing valproic acid is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to valproic acid concentration is obtained, with the maximum rate of aggregation at the lowest valproic acid concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
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 Valproic Acid 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 Valproic Acid II Assay.
Precision and Method Comparison Results:
Versus Roche Valproic Acid II Assay (predicate device):
N = 75
Y = 0.969X + 3.003
R = 0.992
Range = 11.3 to 144.2 µg/mL
NCCLS Precision (Roche ONLINE TDM Valproic Acid):
Level 1: Mean (µg/mL) 34.8, CV% (within run) 0.8, CV% (total) 2.1
Level 2: Mean (µg/mL) 74.1, CV% (within run) 0.6, CV% (total) 2.4
Level 3: Mean (µg/mL) 118.9, CV% (within run) 0.6, CV% (total) 1.9
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 2 2 2003
Roche ONLINE Valproic Acid Assay
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) 845-2000
Contact Person: Mike Flis
Date Prepared: June 27, 2003 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Roche ONLINE TDM Valproic Acid |
| 3) Predicate device | We claim substantial equivalence to the Roche Valproic II Assay [K930734]. |
| 4) Device Description | The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with valproic acid and rapidly aggregate in the presence of a valproic acid antibody solution. When a sample containing valproic acid is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to valproic acid concentration is obtained, with the maximum rate of aggregation at the lowest valproic acid concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained. |
Continued on next page
1
510(k) Summary, Continued
- Intended use For the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. The Roche ONLINE TDM Valproic Acid was evaluated for several 6) Comparison to predicate performance characteristics, including precision, lower detection limit, device 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 Valproic Acid II Assay. The following table presents the precision and method comparison results.
| Roche ONLINE TDM Valproic Acid | Roche Valproic Acid II, (Predicate) | |||||
|---|---|---|---|---|---|---|
| Versus Roche Valproic Acid II Assay | ||||||
| (predicate device) | Versus Abbott TDx Valproic Acid Assay | |||||
| N = 75 | N= 77 | |||||
| Y = $0.969X+3.003$ | Y= $1.08X-0.61$ | |||||
| R = 0.992 | R= 0.972 | |||||
| Range = 11.3 to 144.2 µg/mL | Range = 2.6 to 119.8 µg/mL | |||||
| NCCLS | ||||||
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 34.8 | 74.1 | 118.9 | 20.6 | 65.2 | 118.5 |
| CV% (within run) | 0.8 | 0.6 | 0.6 | 2.3 | 1.5 | 1.3 |
| CV% (total) | 2.1 | 2.4 | 1.9 | 3.4 | 2.3 | 1.7 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 2 2003
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250
K032049 Re:
Trade/Device Name: Roche ONLINE TDM Valproic Acid Assay Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG Dated: June 27, 2003 Received: July 11, 2003
Dear Mr. Flis:
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 Sutman
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
Roche Diagnostics Corporation
510(k) Number (if known): Device Name: Roche ONLINE TDM Valproic Acid Assay Indications for Use:
The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit mal seizures and other generalized and partial complex seizures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alle to
Division Sign Off for Jean Cooker
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032049
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)