SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

K013076 · Beckman Coulter, Inc. · LEH · Dec 12, 2001 · Clinical Toxicology

Device Facts

• Record ID: K013076
• Device Name: SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Dec 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

The SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay. The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with THE OTHON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fof the calibration of Yancomycin.

Device Story

The SYNCHRON Systems Vancomycin Reagent and Calibrator are in vitro diagnostic reagents used on Beckman Coulter SYNCHRON CX and LX clinical chemistry systems. The device utilizes a turbidimetric inhibition immunoassay to measure vancomycin concentration in human serum or plasma samples. The system processes the sample, performs the assay, and provides a quantitative concentration result. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is used by clinicians to monitor vancomycin levels in patients, facilitating therapeutic drug management and dosage adjustments to optimize efficacy and minimize toxicity.

Clinical Evidence

Bench testing only. Method comparison study (N=100) comparing SYNCHRON Vancomycin Assay to Abbott AxSYM Vancomycin Assay yielded a slope of 1.096, intercept of -2.63, and r=0.983. Imprecision studies (N=80 per level) showed within-run %C.V. ranging from 1.7% to 5.3% and total imprecision %C.V. ranging from 2.2% to 7.0% across three concentration levels.

Technological Characteristics

Turbidimetric inhibition immunoassay; mouse monoclonal antibody-based; liquid-stable reagents and calibrators; storage at +2°C to +8°C; designed for integration with SYNCHRON CX and LX automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of vancomycin concentration in human serum or plasma for patients requiring therapeutic drug monitoring of vancomycin.

Regulatory Classification

Identification

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Predicate Devices

• AxSYM® Vancomycin II Assay (K955851)

Submission Summary (Full Text)

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510(k) Summary SYNCHRON® Systems Vancomycin Reagent and Calibrator

KD13076

## 1.0 Submitted By:

Mary Beth Tang Mary Begulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] Fax: [phone]

## Date Submitted: 2.0

September 12, 2001

### Device Name(s): 3.0

- Proprietary Names: 3.1 Prophetary Names.
SYNCHRON® Systems Vancomycin Reagent and Calibrator
- Classification Name: 3.2 Classmeations (21 CFR \$ 862.3950) Vancomycin toxicology calibrator (21 CFR § 862.3200)

## Predicate Device(s): 4.0

| Beckman Coulter | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------------------------------|-------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems<br>Vancomycin (VANC)<br>Reagent and Calibrator | AxSYM® Vancomycin II<br>Assay | Abbott Laboratories,<br>Inc.* | K955851 |

*Abbott Laboratories, Inc., Abbott Park, IL

#### Description: 5.0

The SYNCHRON System Vancomycin (VANC) Reagent and Calibrator are designed for The SYNCHRON System valioning in (VANCHRON CX (CX440CF/404PRO, CX5/6CE/5/5PRO, C CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems.
CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems.
CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) and expre The assay is CX7/7RTS/7/7PRO, CX9ALXJPPRO} and LX (EXEAN RO) of vancomycin concentration in human intended for use in the qualitians wo 100-test cartidges and is packaged separately from the six-level calibrator set.

#### Intended Use: 6.0

The SYNCHRON Systems Vancomycin (VANC) Reagent, in conjunction with the The SYNCHRON Systems Vancomyon Calibrator set, is intented for the quantititive SYNCHRON Systems Vancomycin concentration in human serum or plasma on SYNCHRON Systems.

The SYNCHRON Systems Vancomycin Calibrator, used in onlynntion with SYNCHRON Systems for the calibration of The SYNCHRON Systems Vancomych Calibrator, used in Only Children for the Californial of Vancomycin.

Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: [phone] Facsimile: [phone] www.beckmancoulter.com Internet:

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## 7.0 Comparison to Predicate(s):

| Assay | Aspect/Characteristic | Comments |
|-----------------------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON® Systems<br>VANC Reagent and<br>Calibrator | Intended use | Same as predicate |
| | Sample Type | |
| | Antibody source (mouse monoclonal) | |
| | Liquid-stable reagents and calibrators | |
| | Storage conditions (+2°C to +8°C) | |
| DIFFERENCES | | |
| | Methodology | SYNCHRON: Turbidimetric<br>Inhibition Immunoassay<br>AxSYM: Fluorescence<br>Polarization Immunoassay<br>(FPIA) |
| | Formulation | Specific to methodology |
| | Reportable Range | SYNCHRON:<br>CX: 3.5 - 50 $\mu$ g/mL<br>LX: 3.5 - 40 $\mu$ g/mL<br>LX: ORDAC* 30-60 $\mu$ g/mL<br>AxSYM: 2 - 100 $\mu$ g/mL |
| | Sensitivity | SYNCHRON: 3.5 $\mu$ g/mL<br>AxSYM: 2 $\mu$ g/mL |
| | Sample Size | SYNCHRON:<br>3 $\mu$ L, 2 $\mu$ L (LX ORDAC)<br>AxSYM: 150 $\mu$ L, 94 $\mu$ L (STAT) |

*ORDAC = Over Range Detection and Correction

#### 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 companson and imprecision experiments that relate results obtained from the SYNCHRON Vancomycin Assay to the Abbott AxSYM Vancomycin assay.

| Method Comparison Study Results* | |
|----------------------------------|--|
|----------------------------------|--|

| Analyte | N | Slope | Intercept | r | Predicate Method |
|------------------------------|-----|-------|-----------|-------|----------------------------------|
| SYNCHRON<br>Vancomycin Assay | 100 | 1.096 | -2.63 | 0.983 | Abbott AxSYM<br>Vancomycin Assay |

*Serum patient specimens were analyzed in the range of 3.6 to 51.6 µg/mL vancomyucin. Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON LX and SYNCHRON CX Systems has been established by correlation analysis.

| Sample | Mean (µg/mL) | S.D. (%) | %C.V. | N |
|------------------------|--------------|----------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 8.2 | 0.44 | 5.3 | 80 |
| Level 2 | 21.6 | 0.37 | 1.7 | 80 |
| Level 3 | 36.2 | 0.69 | 1.9 | 80 |
| Total Imprecision | | | | |
| Level 1 | 8.2 | 0.58 | 7.0 | 80 |
| Level 2 | 21.6 | 0.48 | 2.2 | 80 |
| Level 3 | 36.2 | 0.89 | 2.5 | 80 |

# Estimated SYNCHRON LX Vancomvoin Assay Imprecision

The Summary of Safety and Effectiveness information for the SYNCHRON Systems Vancomycin Reagent and Calibrator are found in TAB 1 of this notice and are being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and implementing regulation 21 CFR 807.92.

Beckman Coulter, Inc., Section 510(k) Notification

SYNCHRON® Systems Vancomycin (VANC) Reagent and Calibrator 510(K) Summary

2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2001

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92822-8000

Re: k013076

Trade/Device Name: SYNCHRON® Systems Vancomycin Reagent and Calibrator Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: November 28, 2001 Received: November 29, 2001

Dear Ms. Tangl:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and in you substantial equivalence of your device to a legally marketed nonification. "The Dir 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 Iditionally, for questions on the promotion and advertising of your device, (2017) 594-4565. Traditional [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on Jour responser Assistance at its toll-free number [phone] or Manufactor Internation internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): K013076

Device Name: SYNCHRON® Systems Vancomycin Reagent and Calibrator

Indications for Use:

The SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay.

The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with THE OTHON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fof the calibration of Yancomycin.

| (Division Sign-Off) | |
|-----------------------------------------|-----------------------------------------|
| Division of Clinical Laboratory Devices | Division of Clinical Laboratory Devices |
| 510(k) Number | K613076 |
| | (Division Sign-Off) |
| | 510(k) Number |

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Prescription Use
(per 21 CFR 801.109)

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