(11 days)
K98280
Not Found
No
The device description details a standard immunoassay method based on chemical reactions and turbidimetric measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is used to measure valproic acid levels in serum or plasma, which aids in diagnosis and monitoring, but it does not directly treat or provide therapy to a patient.
Yes
The description explicitly states, "VALP test results may be used in the diagnosis and treatment of valproic acid overdose." This indicates its role in identifying a medical condition.
No
The device description clearly outlines a chemical assay method involving reagents (latex particles, monoclonal antibody) and measurement using bichromatic turbidimetric readings, indicating a hardware component (the Dimension® clinical chemistry system) is required for its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure valproic acid... in serum or plasma." Serum and plasma are biological specimens taken from the human body.
- Purpose: The results are used "in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy." This indicates the device is used for medical purposes related to a patient's health status.
- Method: The device uses a "particle enhanced turbidimetric inhibition immunoassay," which is a laboratory technique performed on biological samples.
These characteristics align directly 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 VALP method for the Dimension® clinical chemistry system is a device used to quantitatively measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
Product codes
LEG
Device Description
The VALP method for the Dimension® clinical chemistry system is a particle enhanced turbidimetric inhibition immunoassay which uses a latex particle-valproic acid conjugate and valproic-acid specific monoclonal antibody (Ab). Valproic acid present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. The rate of aggregation is inversely proportional to the concentration of valproic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340nm and 700nm
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
Split sample comparison between the VALP method for the Dimension® system and the Abbott AxSYM® Valproic Acid assay gave a correlation coefficient of 0.995, slope of 1.10, and an intercept of -2.82 µg/mL when tested with 158 clinical patient samples ranging from 11 - 147.7 ug/mL.
Key Metrics
Correlation coefficient of 0.995, slope of 1.10, and an intercept of -2.82 µg/mL.
Predicate Device(s)
K98280, Abbott AxSYM® Valproic Acid Assay
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
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
DADE BEHRING K98280
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: | Rebecca S. Ayash
Dade Behring Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 8/13/98 |
| Device Name: | Valproic Acid Method |
| Classification Name: | Enzyme Immunoassay, Valproic Acid |
| Predicate Device: | Abbott AxSYM® Valproic Acid Assay |
Device Description: The VALP method for the Dimension® clinical chemistry system is a particle enhanced turbidimetric inhibition immunoassay which uses a latex particle-valproic acid conjugate and valproic-acid specific monoclonal antibody (Ab). Valproic acid present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. The rate of aggregation is inversely proportional to the concentration of valproic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340nm and 700nm
Valproic acid + PR + Ab ------------------------------------------------------------------------------------------------------------------------------------------------------(scatters light at 340nm)
Intended Use: The VALP method for the Dimension® clinical chemistry system is a device used to quantitatively measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
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Comparison to Predicate Device:
| Item | Dimension® VALP
Method | Abbott AxSYM® Valproic
Acid |
|--------------|--------------------------------------------------------------|---------------------------------------------------------|
| Technology | Particle Enhanced
Turbidimetric Inhibition
Immunoassay | Fluorescence
Polarization
Immunoassay |
| Detection | Rate turbidimetric
absorption | Fluorometric endpoint
measurement |
| Sample Size | 3μL | 150μL |
| Sample Type | Serum or plasma | serum or plasma |
| Intended Use | For the quantitative
measurement of valproic
acid | For the quantitative
measurement of valproic
acid |
Comments on Substantial
Equivalence: Split sample comparison between the VALP method for the Dimension® system and the Abbott AxSYM® Valproic Acid assay gave a correlation coefficient of 0.995, slope of 1.10, and an intercept of -2.82 µg/mL when tested with 158 clinical patient samples ranging from 11 - 147.7 ug/mL.
Conclusion: The VALP Method for the Dimension® clinical chemistry system is substantially equivalent in principle and performance to the Abbott AxSYM® Valproic Acid Assay based on the split sample comparison summarized above.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/13/98
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Image /page/2/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 three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 25 1998
Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re : K982880 Valproic Acid Method Regulatory Class: II Product Code: LEG Dated: Auqust 13, 1998 Received: August 14, 1998
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of l
Indications Statement
Device Name: Valproic Acid (VALP) Method
Indications for Use: The VALP method for the Dimension® RxL clinical chemistry system is a device used to measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
Rebecca S. Ayresk
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/13/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K982880
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use