(28 days)
Not Found
No
The document describes a reagent kit for measuring valproic acid concentration using a turbidimetric immunoassay method on specific laboratory systems. There is no mention of AI or ML in the intended use, device description, or performance summary.
No.
The device is a reagent used for the quantitative determination of valproic acid concentration in human serum or plasma to monitor drug levels, not to provide therapy itself.
Yes
The device is intended for the "quantitative determination of valproic acid concentration in human serum or plasma," which provides information used to monitor drug therapy for suspected inadequate dose or toxicity, thus aiding in diagnosis or treatment decisions.
No
The device is a reagent kit intended for use with specific hardware systems (SYNCHRON Systems). It is a chemical component used in a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of valproic acid concentration in human serum or plasma." This involves testing a sample taken from the human body (in vitro) to diagnose or monitor a medical condition (valproic acid levels for therapeutic drug monitoring).
- Method: The description mentions a "particle enhanced turbidimetric inhibition immunoassay method," which is a laboratory technique used to analyze biological samples.
- Device Description: The device is a "reagent kit" designed for use on "SYNCHRON Systems," which are laboratory analyzers.
- Predicate Device: The predicate device listed is also a "SYNCHRON Systems VPA Reagent," further indicating its nature as a diagnostic reagent.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON® Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems.
Valproic Acid is an anticonvulsant drug. It is indicated for the treatment of absence (petite mal), generalized tonic-clinic and myoclonic seizures. Valproic Acid therapy is monitored for suspected inadequate dose or toxicity.
Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.
Product codes
LEG
Device Description
The SYNCHRON Systems VPA Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO. CX5/5CE/5A/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and SYNCHRON LX (LX20/PRO/LXi) Systems. The reagent kit contains two 100-test cartridges, and is packaged separately from the associated calibrators.
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
Performance data from validation testing supports equivalency.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with a white wave-like design inside, followed by the company name "BECKMAN COULTER" in bold, sans-serif font. The text is arranged in two lines, with "BECKMAN" on the top line and "COULTER" on the bottom line.
510(k) Summary
JUL 1 5 2003
1.0 Submitted By:
Mary Beth Tanq Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted
June 16, 2003
3.0 Device Name(s):
-
3.1 Proprietary Names
SYNCHRON® Systems Valproic Acid Reagent -
3.2 Classification Names
Neuroleptic drugs radioreceptor assay test system (21 CFR § 862.3645)
4.0 Legally Marketed Device
The SYNCHRON Systems Valproic Acid (VPA) Reagent claims substantial equivalence to the Beckman Coulter SYNCHRON Systems VPA Reagent currently in commercial distribution, FDA 510(k) Number K961256.
5.0 Device Description
The SYNCHRON Systems VPA Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO. CX5/5CE/5A/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and SYNCHRON LX (LX20/PRO/LXi) Systems. The reagent kit contains two 100-test cartridges, and is packaged separately from the associated calibrators.
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Valproic Acid Reagent File: VPA_s510k.doc 6/03
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
1
6.0 Intended Use
Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON® Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The modification to the SYNCHRON Systems VPA assay involves a non-reactive ingredient change to the reagent formulation, optimization of the operating parameters on the LX (LX20/PRO/LXi) instrument platform, and updated performance claims (equivalency, precision) in the product inserts.
8.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
。""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The seal is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 15 2003
Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., - M/S W-104 Box 8000 Brea, CA 92822-8000
Re: K031870
Trade/Device Name: SYNCHRON® Systems Valproic Acid Reagent Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG Dated: June 16, 2003 Received: June 17, 2003
Dear Ms. Tang:
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 i 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
page 1 of 1
510(k) Number (if known): To be assigned
Made with FlippingBook
SYNCHRON® Systems Valproic Acid Reagent Device Name:
Indications for Use:
Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON® Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems.
Valproic Acid is an anticonvulsant drug. It is indicated for the treatment of absence (petite mal), generalized tonic-clinic and myoclonic seizures. Valproic Acid therapy is monitored for suspected inadequate dose or toxicity.
Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.
(b) Classification. Class II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use __
Optional Format 1-2-96
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031870
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Valproic Acid Reagent File: VPA s510k.doc 6/03