SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

K031870 · Beckman Coulter, Inc. · LEG · Jul 15, 2003 · Clinical Toxicology

Device Facts

• Record ID: K031870
• Device Name: SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

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.

Device Story

The SYNCHRON Systems Valproic Acid Reagent is an in vitro diagnostic reagent used on Beckman Coulter SYNCHRON CX and LX clinical chemistry systems. It utilizes a particle-enhanced turbidimetric inhibition immunoassay (PETINIA) to measure valproic acid concentration in human serum or plasma samples. The device is operated by laboratory personnel in a clinical setting. The system processes the sample, and the resulting concentration measurement is provided to the healthcare provider to assist in monitoring therapeutic drug levels, adjusting dosages, and managing potential toxicity in patients treated for seizures. The modification described involves a non-reactive ingredient change to the reagent formulation and optimized operating parameters for the LX instrument platform.

Clinical Evidence

Bench testing only. Performance data provided to support equivalency, including precision and method comparison studies.

Technological Characteristics

Particle-enhanced turbidimetric inhibition immunoassay (PETINIA). Reagent kit contains two 100-test cartridges. Designed for use on automated SYNCHRON CX and LX clinical chemistry analyzer platforms.

Indications for Use

Indicated for patients undergoing valproic acid therapy for the treatment of absence (petite mal), generalized tonic-clonic, and myoclonic seizures. Used for monitoring valproic acid concentration to assess for suspected inadequate dosing or toxicity.

Regulatory Classification

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.

Predicate Devices

• SYNCHRON Systems VPA Reagent (K961256)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

# 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

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#### 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.

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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).

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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 [phone]. 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 [phone] or [phone] 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

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page 1 of 1

510(k) Number (if known): To be assigned

Made with FlippingBook

K031870

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