SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT

K970919 · Beckman Instruments, Inc. · KNK · May 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970919
• Device Name: SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: May 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Indications for Use

The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

Device Story

Reagent kit for quantitative uric acid measurement in serum, plasma, and urine; used with Beckman SYNCHRON CX and LX clinical chemistry analyzers. Operates via timed endpoint methodology at 37°C with absorbance reading at 520 nm. System performs automated calibration and, on LX systems, automated sample dilution for urine. Used in clinical laboratory settings by trained personnel. Output provides uric acid concentration values to assist clinicians in diagnosing and monitoring renal and metabolic conditions. Benefits include standardized, automated testing workflow and expanded measuring range capabilities on newer analyzer platforms.

Clinical Evidence

Bench testing only. Method comparison study (n=79 serum/plasma, n=78 urine) between SYNCHRON LX and CX systems showed high correlation (r=0.9985 for serum/plasma; r=0.9990 for urine). Linearity confirmed across default and ORDAC ranges. Imprecision studies (n=80) demonstrated low variability, with total imprecision %C.V. ranging from 0.8% to 1.9%.

Technological Characteristics

In vitro diagnostic reagent for clinical chemistry analyzers. Employs timed endpoint spectrophotometric measurement at 520 nm. Supports automated calibration and onboard dilution. Measuring range: 0.5–12.0 mg/dL (default), 5.0–120 mg/dL (urine/ORDAC), and 9.0–21.0 mg/dL (ORDAC serum/plasma).

Indications for Use

Indicated for the quantitative determination of uric acid in serum, plasma, and urine samples to aid in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, and for patients receiving cytotoxic drugs.

Regulatory Classification

Identification

A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Predicate Devices

• Beckman Dri-STAT® Uric Acid Trinder Reagent (K881498)
• SYNCHRON CX Clinical Systems (K965240)

Submission Summary (Full Text)

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Uric Acid Reagent
Summary of Safety & Effectiveness
K970919
MAY 21, 1997

Summary of Safety & Effectiveness
SYNCHRON ® Systems Uric Acid (URIC) Reagent

## 1.0 Submitted By:

Sheri Hall
Product Submissions Manager
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

## 2.0 Date Submitted:

3 March 1997

## 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON® Systems Uric Acid (URIC) Reagent

### 3.2 Classification Name

Uric Acid test system. (21 CFR § 862.1775)

## 4.0 Predicate Device(s):

| Product | Predicate | Predicate Company | Docket Number |
| --- | --- | --- | --- |
| Beckman SYNCHRON Systems Uric Acid (URIC) Reagent as used on the SYNCHRON CX Systems | Beckman Dri-STAT® Uric Acid Trinder Reagent | Beckman Instruments, Inc | K881498 |
| SYNCHRON LX Clinical System | SYNCHRON CX Clinical Systems | Beckman Instruments, Inc. | **K965240 |

**K965240 for the LX SYNCHRON System is currently under review.

file: UA510KS.DOC

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Uric Acid Reagent
Summary of Safety & Effectiveness

# 5.0 Description:

The SYNCHRON Systems Uric Acid (URIC) reagent is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. When used in conjunction with SYNCHRON MULTI™ Calibrator, it is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and urine samples. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

# 6.0 Intended Use:

The SYNCHRON Systems Uric Acid (URIC) reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

# 7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.

## Similarities

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON Systems (URIC) Reagent | intended use | same: quantitative determination of uric acid in human serum, plasma, and urine |
| | chemical reaction | same: a timed endpoint methodology |
| | reagent components and packaging | same: same reagent formulation and packaging materials |
| | measurement method | same: runs the reaction at 37°C and reads an endpoint at 520 nm |
| | measuring range
default range: serum/plasma
urine range (with on-line or off-line dilution) | same: (0.5 - 12.0 mg/dL)
(5 - 120 mg/dL) |
| | calibration | same: single point update |

file: UA510KS.DOC

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Uric Acid Reagent
Summary of Safety & Effectiveness
3

## Differences

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON Systems (URIC) Reagents | Measuring range expansion | The LX System may utilize ORDAC serum and plasma samples to expand the measuring range to 9.0 mg/dL to 21.0 mg/dL |
| | Urine application | the LX System performs the 1:10 sample dilution onboard, where the CX System must have the dilution prepared off-line |

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments that relate results obtained from the SYNCHRON Systems Uric Acid Reagent run on the SYNCHRON CX Systems to the SYNCHRON Systems Uric Acid Reagent run on the SYNCHRON Systems LX.

### Method Comparison Study Results

| Reagent (Analyte) | Slope | Intercept (mg/dL) | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| Serum/Plasma
SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON LX System | 0.977 | -0.020 | 0.9985 | 79 | Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System |
| Urine
SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON LX System | 0.995 | 0.116 | 0.9990 | 78 | Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System |

file: UA510KS.DOC
22

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Uric Acid Reagent
Summary of Safety & Effectiveness

## Linearity Study Results

| Analyte | Sample Type | Option | Measuring Range | Assessment |
| --- | --- | --- | --- | --- |
| SYNCHRON Systems | serum | default | 0.5 - 12.0 mg/dL | linear |
| URIC | | ORDAC | 5.0 - 120 mg/dL | linear |
| Reagent | urine | default | 5.0 - 120 mg/dL | linear |

## Estimated Imprecision

| SAMPLE | Mean (mg/dL) | SD (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 2.42 | 0.03 | 1.1% | 80 |
| Level 2 | 10.48 | 0.05 | 0.5% | 80 |
| Total Imprecision | | | | |
| Level 1 | 2.42 | 0.05 | 1.9% | 80 |
| Level 2 | 10.48 | 0.08 | 0.8% | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

file: UA510KS.DOC
21

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 21 1997
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Sheri Hall
Manager, Premarket Regulatory
Beckman Instruments, Inc.
200 S. Kraemer Boulevard, M/S W-337
P.O. Box 8000
Brea, California 92822-8000

Re: K970919
SYNCHRON® Systems Uric Acid (URIC) Reagent
Regulatory Class: I
Product Code: KNK
Dated: March 5, 1997
Received: March 12, 1997

Dear Ms. Hall:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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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Page 2

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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K970919
page 1 of 1

510(k) Number (if known):

Device Name: SYNCHRON® Systems Uric Acid (URIC) Reagent

Indications for Use:

The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

21 CFR § 862.1775 Uric acid Test System

(a) Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
(b) Classification. Class I.

(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