SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT

K961256 · Beckman Instruments, Inc. · LEG · May 15, 1996 · Clinical Toxicology

Device Facts

• Record ID: K961256
• Device Name: SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: LEG · Clinical Toxicology
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Device Story

The SYNCHRON Systems Valproic Acid (VPA) test system is an in vitro diagnostic reagent kit used with SYNCHRON clinical analyzers (CX4/CX5/CX7 series). It measures valproic acid concentrations in human serum or plasma samples. The system utilizes the SYNCHRON Drug Calibrator 1 for calibration. Operated by laboratory technicians in clinical settings, the device provides quantitative results to healthcare providers. These results assist in therapeutic drug monitoring, allowing clinicians to adjust valproic acid dosages to maintain therapeutic levels and optimize patient outcomes.

Clinical Evidence

Bench testing only. Precision studies (n=80 per level) demonstrated within-run imprecision (%CV) of 2.0-3.1% and total imprecision of 2.7-4.6% across low, mid, and high ranges. Method comparison against predicate (n=104) yielded r=0.9857. Analytical measuring range established at 10-150 μg/mL.

Technological Characteristics

In vitro diagnostic reagent system for quantitative immunoassay. Designed for use on Beckman SYNCHRON CX series clinical analyzers. Measuring range 10-150 μg/mL. Stability of 24 months for both reagent and calibrator.

Indications for Use

Indicated for the quantitative measurement of valproic acid in human serum and plasma for patients requiring therapeutic drug monitoring.

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

• TDxFLx® Valproic Acid Reagent (K904226)

Submission Summary (Full Text)

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200 South Kraemer Boulevard, Box 8000, Brea, CA 92621-8000 • [phone]
11

# BECKMAN
Summary of Safety and Effectiveness
Beckman Instruments, Inc.
SYNCHRON Systems Valproic Acid (VPA) Reagent
Section 510(k) Notification

MAY 15 1996
K961256

## 1.0 Submitted By:
K961256

Paul Trujillo
Sr. Regulatory Specialist
Beckman Instruments, Inc.
200 S. Kraemer Blvd. MS W337
Brea CA 92622-8000
Telephone: [phone]
FAX: [phone]

## 2.0 Date Submitted:
March 29, 1996

## 3.0 Device Name:
### 3.1 Proprietary Names:
SYNCHRON® Systems Valproic Acid (VPA) Reagent
SYNCHRON® Systems Drug Calibrator 1

### 3.2 Classification Names:
Valproic Acid Test System (Not Classified)
Calibrator (21 CFR §862.1150)

## 4.0 Predicate Devices:

### PREDICATE DEVICE SELECTION

| SYNCHRON Systems Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| Valproic Acid Reagent | TDxFLx®** Valproic Acid Reagent | Abbott* Laboratories, Inc. | K904226 |

*Abbott Laboratories, Abbott Park, IL 60064
** Trademark of Abbott Laboratories, Inc.

## 5.0 Description:
The Beckman SYNCHRON Systems Valproic Acid (VPA) test system used in conjunction with the SYNCHRON Systems Drug Calibrator 1 is designed for optimal performance on the Beckman SYNCHRON family of clinical analyzers for the quantitative measurement of valproic acid in serum and plasma. The SYNCHRON family of clinical analyzers include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Beckman Instruments, Inc.
fax: [phone] • telex 31-78413

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6.0

**Intended Use:**

The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

7.0

**Comparison to Predicate:**

**Method Comparison**

| Analyte | Slope | Intercept | r | n | Predicate |
| --- | --- | --- | --- | --- | --- |
| Valproic Acid | 1.0443 | 2.00 | 0.9857 | 104 | Abbott TDxFLx Valproic Acid Reagent |

8.0

**Precision:**

**Valproic Acid (VPA) Imprecision Study Results Within Run Imprecision**

| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Low | 34.5 | 1.1 | 3.1 | 80 |
| Mid-Range | 83.3 | 1.6 | 2.0 | 80 |
| High | 131.3 | 3.1 | 2.4 | 80 |

**Valproic Acid (VPA) Imprecision Study Results Total Imprecision**

| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Low | 34.5 | 1.6 | 4.6 | 80 |
| Mid-Range | 83.3 | 3.1 | 3.8 | 80 |
| High | 131.3 | 3.6 | 2.7 | 80 |

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9.0
**Analytic Range:**

| Analyte | Sample Type | Measuring Range (μg/mL) | Assessment |
| --- | --- | --- | --- |
| Valproic Acid | Serum/Plasma | 10-150 | Linear |

10.0
**Summary of Stability Data:**

| Reagent and Calibrator | Findings |
| --- | --- |
| Valproic Acid (VPA) Reagent | 24 Months (Reagent) |
| Valproic Acid Calibrator (Drug Cal 1) | 24 Months (Calibrator) |

This summary of safety and effectiveness is being submitted in compliance to the requirements of the Safe Medical Device Act and the implementing regulation 21 CFR §807.92.