SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

K014173 · Beckman Coulter, Inc. · DKJ · Feb 15, 2002 · Clinical Toxicology

Device Facts

• Record ID: K014173
• Device Name: SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: DKJ · Clinical Toxicology
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3830
• Device Class: Class 2

Indications for Use

Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Device Story

The SYNCHRON Systems Salicylate Reagent is an in vitro diagnostic reagent kit used on Beckman Coulter SYNCHRON CX and LX clinical chemistry systems. It utilizes a colorimetric timed-endpoint method to measure salicylate concentration in serum or plasma samples. The system processes 4 µL of patient sample; reagents are liquid-stable. The device is operated by laboratory personnel in a clinical setting. The system provides quantitative salicylate concentration results to clinicians, which are used to diagnose salicylate overdose and monitor therapeutic levels. This assists in clinical decision-making regarding patient treatment and dosage adjustments.

Clinical Evidence

Bench testing only. Method comparison study (N=75) against the Abbott TDx Salicylate Assay showed a slope of 1.096, intercept of -0.14, and r=0.989. Imprecision studies (N=80 per level) demonstrated within-run CVs of 1.0% to 3.8% and total imprecision CVs of 2.3% to 6.7% across three concentration levels (9.7, 31.7, and 82.7 mg/dL).

Technological Characteristics

Liquid-stable enzymatic colorimetric reagent kit. Designed for use on automated SYNCHRON CX and LX clinical chemistry analyzers. Reportable range: 4.0 - 100 mg/dL. Sample volume: 4 µL. Storage: +2°C to +8°C.

Indications for Use

Indicated for the quantitative determination of salicylate concentration in serum or plasma for patients requiring diagnosis and treatment of salicylate overdose or monitoring of salicylate levels for therapeutic management.

Regulatory Classification

Identification

A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Predicate Devices

• TDx® Salicylate Assay (K844070)

Submission Summary (Full Text)

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# FEB 1 5 2002

K014173

510(k) Summary SYNCHRON® Systems Salicylate Reagent

## 1.0 Submitted By:

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

# 2.0 Date Submitted:

December 19, 2001

# 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Salicylate Reagent

## 3.2 Classification Name

Salicylate test system (21 CFR § 862.3830) Clinical toxicology calibrator (21 CFR § 862.3200)

# 4.0 Predicate Device(s):

| Beckman Coulter | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------------|-----------------------|----------------------------|------------------|
| SYNCHRON® Systems<br>Salicylate (SALY) Reagent | TDx® Salicylate Assay | Abbott Laboratories, Inc.* | K844070 |

*Abbott Laboratories, Inc., Abbott Park, IL

## 5.0 Description:

The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.

## 6.0 Intended Use:

Salicylate (SALY) Reagent, when used in conjunction with the SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate concentration in serum or plasma on SYNCHRON Systems.

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

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# Comparison to Predicate(s): 7.0

| Assay | Aspect/Characteristic | Comments |
|--------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------|
| <b>SIMILARITIES</b> | | |
| SYNCHRON®<br>Systems SALY<br>Reagent | Intended use | Same as predicate |
| | Sample Type | |
| | Liquid-stable reagents and calibrators | |
| | Storage conditions (+2°C to +8°C) | |
| <b>DIFFERENCES</b> | | |
| | Methodology | SYNCHRON: Enzymatic,<br>colorimetric<br>TDx: Fluorescence Polarization<br>Immunoassay (FPIA) |
| | Formulation | Specific to methodology |
| | Reportable Range | SYNCHRON: 4.0 - 100 mg/dL<br>TDx: 0.0 - 80 mg/dL |
| | Sensitivity | SYNCHRON: 4.0 mg/dL<br>TDx: 0.5 mg/dL |
| | Sample Size | SYNCHRON: 4 µL<br>TDx: 3 µL |

# Summary of Performance Data: 8.0

Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of The data in the Premarket Notincation on Salesy and enrocks in commercial distribution.
substantial equivalence to chemistry test systems and imperising experiments that substantial equivalence to chemistry test systems and imprecision experiments that
Equivalence is demonstrated Equivalence is demonstrated through methou companson and inforcessor of any and Salicylate assay.

Method Comparison Study Results*

| Analyte | N | Slope | Intercept | r | Predicate Method |
|------------------------------|----|-------|-----------|-------|--------------------------------|
| SYNCHRON<br>Salicylate Assay | 75 | 1.096 | -0.14 | 0.989 | Abbott TDx Salicylate<br>Assay |

Salicylate Assay
*Serum patient specimens were analyzed in the range of 5.1 to 9.52 mg/d. salicylate. Data shown *Serum patient specimens were analyzed in the large of 3.1 to occ. mg of saily.
was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON CX has been
Shas collec was collected using of NON DN DN ON DV Cystems.

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 9.7 | 0.36 | 3.8 | 80 |
| Level 2 | 31.7 | 0.63 | 2.0 | 80 |
| Level 3 | 82.7 | 0.83 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 9.7 | 0.65 | 6.7 | 80 |
| Level 2 | 31.7 | 0.86 | 2.7 | 80 |
| Level 3 | 82.7 | 1.93 | 2.3 | 80 |

Estimated SYNCHRON LX Salicylate Assay Imprecision

The Summary of Safety and Effectiveness information for the SYNCHRON Systems The Summary of Saley and Ellectively and are being submitted in accordance Salicylate Reagent is found in TAB T of this notes and are beling cability of the requirementing regulation 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k014173

> Trade/Device Name: SYNCHRON® Systems Salicylate Reagent Regulation Number: 21 CFR 862.3830; 21 CFR 862.1150 Regulation Name: Salicylate test system; Calibrator Regulatory Class: Class II; Class II Product Code: DKJ; JIS Dated: December 19, 2001 Received: December 20, 2001

FEB 1 5 2002

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 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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/odrb/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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K014173

page 1 of 1

510(k) Number (if known): Not yet assigned

Device Name: SYNCHRON® Systems Salicylate Reagent

Indications for Use:

Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Jan
(Division Sign-Off)
Division of Clinical
510(k) Number K014173

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (per 21 CFR 801.109) | |

OR

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