SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT

K971505 · Beckman Instruments, Inc. · CHH · Jun 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971505
• Device Name: SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Device Story

The SYNCHRON Systems Cholesterol (CHOL) Reagent is an in vitro diagnostic reagent kit used with Beckman clinical chemistry analyzers (e.g., SYNCHRON LX20). It utilizes an enzymatic cholesterol oxidase reaction to measure cholesterol concentration in human serum or plasma samples. The system performs an endpoint measurement at 520 nm. The device is operated by laboratory personnel in a clinical setting. The output is a quantitative cholesterol concentration value, which assists clinicians in diagnosing and managing lipid and lipoprotein metabolism disorders. The system supports both a default measurement range (5-750 mg/dL) and an expanded range (600-1000 mg/dL) for the LX systems.

Clinical Evidence

Bench testing only. Method comparison studies (n=79 vs. predicate; n=39 vs. Abell-Kendall reference method) showed high correlation (r=0.9996 and r=0.9961 respectively). Within-run imprecision was evaluated across default (98.7-213.2 mg/dL) and extended (716.2-876.25 mg/dL) ranges, with %C.V. values ranging from 0.98% to 2.28%.

Technological Characteristics

Enzymatic cholesterol oxidase reaction; endpoint spectrophotometric measurement at 520 nm; two-cartridge reagent kit; single-level serum-based calibration; compatible with SYNCHRON clinical chemistry analyzers; supports expanded measurement range up to 1000 mg/dL.

Indications for Use

Indicated for the quantitative determination of human cholesterol in serum or plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• SYNCHRON CX Systems Cholesterol (CHOL) Reagent (K934046)
• ASTRA & SYNCHRON CX3 (K881498, K881495)
• SYNCHRON CX4/CX5 Systems (K926060, K904220, K904219, K950958)
• SYNCHRON CX7 DELTA System (K965240)

Submission Summary (Full Text)

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Kanisos

June 11, 1997

# Summary of Safety & Effectiveness SYNCHRON® Systems Cholesterol (CHOL) Reagent

## 1.0 Submitted By:

Maria Zeballos Scientist II, Chemistry Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-150 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

### 2.0 Date Submitted:

18 April 1997

### 3.0 Device Name(s):

## 3.1 Proprietary Names

SYNCHRON® Systems Cholesterol (CHOL) Reagent

## 3.2 Classification Names

Cholesterol (Total) Test system (21 CFR 862.1175)

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## Predicate Device(s): 4.0

| SYNCHRON<br>Reagent | Predicate | Predicate<br>Company | Docket<br>Number |
|---------------------------------------------------|------------------------------------------------------|------------------------------|--------------------|
| SYNCHRON Systems<br>Cholesterol (CHOL)<br>Reagent | SYNCHRON CX<br>Systems Cholesterol<br>(CHOL) Reagent | Beckman<br>Instruments, Inc. | K934046 |
| SYNCHRON<br>CX4/CX5 Systems | ASTRA &<br>SYNCHRON CX3 | Beckman<br>Instruments, Inc | K881498<br>K881495 |
| SYNCHRON CX5CE<br>System | SYNCHRON<br>CX4/CX5 Systems | Beckman<br>Instruments, Inc | K926060 |
| SYNCHRON<br>CX4CE/CX7 System | SYNCHRON<br>CX4/CX5 Systems | Beckman<br>Instruments, Inc | K904220<br>K904219 |
| SYNCHRON Systems<br>CX4/CX5 Systems | SYNCHRON Systems<br>CX4/CX5 Systems | Beckman<br>Instruments, Inc | K950958 |
| SYNCHRON LX 20<br>System | SYNCHRON CX7<br>DELTA System | Beckman<br>Instruments, Inc. | K965240 |

### 5.0 Description:

The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.

### 6.0 Intended Use:

The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

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## 7.0 Comparison to Predicate(s):

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

| Reagent | Aspect/<br>Characteristic | Comments |
|---------------------------------------------------------|---------------------------|---------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON<br>Systems<br>Cholesterol<br>(CHOL)<br>Reagent | Intended use | Same; determination of<br>cholesterol concentration in<br>serum or plasma |
| | Chemical reaction | Same; enzymatic, Cholesterol<br>Oxidase reaction |
| | Measurement<br>method | Same; endpoint measurement at<br>520 nm |
| | Packaging | Same; a two cartridge reagent kit |
| | Reaction time | Same; 32 seconds |
| | Calibration | Same; single level serum base<br>calibrator |

| Reagent | Aspect/<br>Characteristic | Comments |
|---------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| SYNCHRON<br>Systems<br>Cholesterol<br>(CHOL)<br>Reagent | Range expansion | The SYNCHRON CX Systems<br>measures cholesterol<br>concentrations at the initial range<br>of 5 -750 mg/dL; while the<br>SYNCHRON LX Systems<br>measures cholesterol<br>concentrations at the initial range<br>of 5-750 mg/dL and expanded<br>range of 600 - 1000 mg/dL |

10_sse, 04/97

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#### Summary of Performance Data: 8.0

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 studies and imprecision experiments that relate results obtained from SYNCHRON Systems Cholesterol Reagent.

| Reagent<br>(Analyte) | Slope | Intercept<br>(mg/dL) | r | n | Predicate Method |
|---------------------------------------------------------|-------|----------------------|--------|----|---------------------------------------------------------|
| SYNCHRON<br>Systems<br>Cholesterol<br>(CHOL)<br>Reagent | 0.983 | 2.41 | 0.9996 | 79 | SYNCHRON<br>Systems<br>Cholesterol<br>(CHOL)<br>Reagent |
| SYNCHRON<br>Systems<br>Cholesterol<br>(CHOL)<br>Reagent | 1.002 | -2.07 | 0.9961 | 39 | Abell-Kendall<br>Reference<br>Method |

# Method Comparison Study Results SYNCHRON Systems Cholesterol (CHOL) Reagent

Estimated Within-Run Imprecision Cholesterol Reagent

| Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N | |
|---------------------------------------|-----------------|-----------------|-------|----|--|
| Within-Run Imprecision Default Range | | | | | |
| Level 1 | 98.7 | 1.08 | 1.09 | 80 | |
| Level 2 | 155.4 | 1.65 | 1.06 | 80 | |
| Level 3 | 213.2 | 20.8 | 0.98 | 80 | |
| Within-Run Imprecision Extended Range | | | | | |
| Level 1 | 716.2 | 12.53 | 2.28 | 20 | |
| Level 2 | 876.25 | 19.94 | 1.74 | 20 | |

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.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 1 1997

Sheri Hall Manager, Premarket Regulatory Beckman_Instruments _ Inc ... . 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000 48 Re : K971505 SYNCHRON® Systems Cholesterol (CHOL) Reagent Regulatory Class: I Product Code: CHH Dated: April 18, 1997 Received: April 25, 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 reqistration, 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. ਕੇ 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 requlation (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 requlation 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 Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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of page -

510(k) Number (if known):

Device Name:

Indications for Use:

The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

21 CFR 862.1175 Cholesterol (total) test system

(a) Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorder involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
K947555

510(k) Number

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96