SYNCHRON MULTI CALIBRATOR

K110251 · Beckman Coulter, Inc. · JIX · May 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110251
• Device Name: SYNCHRON MULTI CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. Prescription use.

Device Story

SYNCHRON MULTI CALIBRATOR is a liquid, ready-to-use, multi-analyte in vitro diagnostic calibrator; matrix consists of human serum stabilized with ethylene glycol. Device used on Beckman Coulter SYNCHRON CX, LX, and UniCel DxC family of analyzers. Calibrator provides known concentration values for specific analytes (Albumin, BUN, Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, Uric Acid) to calibrate clinical chemistry assays. Healthcare providers use the resulting assay measurements to aid in clinical decision-making. Product is handled by laboratory technicians; requires storage at -15 to -20°C.

Clinical Evidence

No clinical data. Bench testing only. Value assignment for Lactate and Magnesium was validated through multiple runs across multiple SYNCHRON analyzer platforms (CX5 CE, CX9 Pro, LX20 Pro, DxC800) using multiple reagent lots. Traceability established via NIST SRM 929 for Magnesium and manufacturer working calibrators for Lactate.

Technological Characteristics

Liquid, ready-to-use, human serum matrix stabilized with ethylene glycol. Multi-analyte mixture. Traceable to NIST SRM 927a, 915, 911b, 917a, 929, 3139a, 912a, 913b. Storage: -15°C to -20°C. Open vial stability: 20 days at 2°C to 8°C. Packaging: 6 x 20 mL bottles.

Indications for Use

Indicated for use as a calibrator for clinical chemistry assays on Beckman Coulter SYNCHRON systems. No specific patient population or disease state is defined as this is a laboratory calibration product.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• SYNCHRON Multi Calibrator (K883181)

Submission Summary (Full Text)

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K 110251

MAY 2 5 2011

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic to the left of the company name. The graphic contains two curved lines that are parallel to each other. The text "BECKMAN COULTER" is to the right of the graphic, with "BECKMAN" on the top line and "COULTER" on the bottom line.

Summary of Safety & Effectiveness SYNCHRON® Systems SYNCHRON Multi Calibrator

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.

# 1.0 Submitted By:

Yvette Lloyd, JD Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E2.SE.08 Brea, CA 92821 Phone: [phone] FAX: [phone] email: [e-mail]

## 2.0 Date Submitted:

January 26, 2011 and May 5, 2011

# 3.0 Device Name(s):

- 3.1 Proprietary Names SYNCHRON Multi Calibrator
## 3.2 Classification Name

Calibrator, Secondary or Multi-Analyte Mixture (Product Code - JIT/JIX), 21 CFR.1150, Class II, (75)

## 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|---------------------------|------------------------------|--------------|------------------|
| SYNCHRON Multi Calibrator | SYNCHRON Multi<br>Calibrator | Beckman | K883181 |

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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## 5.0 Description:

This is a liquid, ready-to-use, multi analyte, IVD calibrator. The SYNCHRON Multi Calibrator is prepared in a human serum matrix which is stabilized by the use of ethylene glycol. During manufacture, the multiple constituents are spiked into the matrix at the desired concentration levels. The analyte(s) in this calibrator is traceable using prEN ISO 17511 to the reference materials listed below.

| Measurand | Traceable To |
|-----------|-----------------------------------|
| ALB | NIST 927a' |
| CA | NIST SRM 915 |
| CHOL | NIST 911b |
| GLU | NIST SRM 917a |
| Lactate | Manufacturer's working calibrator |
| MG | NIST SRM 929 |
| PHOS | NIST SRM 3139a |
| PHS | NIST SRM 3139a |
| PO4 | NIST SRM 3139a |
| TP | NIST SRM 927a |
| TG, TG-B | Manufacturer's working calibrator |
| UREA | NIST SRM 912a |
| BUN | NIST SRM 912a |
| URIC | NIST SRM 913b |

Value assignment and stability data is available with Beckman Coulter.

#### 6.0 Intended Use:

The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.

#### 7.0 Comparison to Predicate(s):

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

| | Predicate Device: SYNCHRON Multi Calibrator | Proposed Device: SYNCHRON Multi Calibrator |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Beckman CX MULTI CALIBRATOR, in<br>conjunction with SYNCHRON CX reagents, is<br>intended for use on SYNCHRON CX4 and CX5<br>Systems for the calibration of Albumin, Blood Urea<br>Nitrogen (Urea), Calcium, Cholesterol, Creatinine,<br>Glucose, Inorganic Phosphorus, Total Protein,<br>Triglycerides, and Uric Acid. | The SYNCHRON MULTI CALIBRATOR, used in<br>conjunction with SYNCHRON reagents, is intended for<br>use on SYNCHRON Systems for the calibration of<br>Albumin, Blood Urea Nitrogen (Urea), Calcium,<br>Cholesterol, Glucose, Inorganic Phosphorus, Lactate,<br>Magnesium, Total Protein, Triglycerides, and Uric Acid. |
| Matrix base | The calibrator is prepared from human serum and<br>stabilized by the use of ethylene glycol. | The calibrator is prepared from human serum and<br>stabilized by the use of ethylene glycol. |
| Levels | 1 | 1 |
| Form | Liquid, ready to use | Liquid, ready to use |
| Open vial stability | 20 days at +2°C to +8°C | 20 days at +2°C to +8°C |
| Storage | -15°C to -20°C | -15°C to -20°C |
| Packaging | 6 X 20 mL bottles | 6 X 20 mL bottles |
| Real time stability | 24 months | 24 months |

List of design inputs that are the same between the two devices

Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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

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| Differences | Predicate Device: SYNCHRON Multi<br>Calibrator | Proposed Device: SYNCHRON Multi<br>Calibrator |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Value assigned<br>analytes | Albumin, Blood Urea Nitrogen (Urea), Calcium,<br>Cholesterol, Creatinine, Glucose, Inorganic<br>Phosphorus, Total Protein, Triglycerides, and<br>Uric Acid. | Albumin, Blood Urea Nitrogen (Urea), Calcium,<br>Cholesterol, Glucose, Inorganic Phosphorus,<br>Lactate, Magnesium, Total Protein,<br>Triglycerides, and Uric Acid. |
| Formulation:<br>Multiple<br>constituents | Albumin, Blood Urea Nitrogen (Urea), Calcium,<br>Cholesterol, Creatinine, Glucose, Inorganic<br>Phosphorus, Lactate, Magnesium, Total<br>Protein, Triglycerides, Uric Acid and Iron (not<br>value assigned). | Albumin, Blood Urea Nitrogen (Urea), Calcium,<br>Cholesterol, Glucose, Inorganic Phosphorus,<br>Lactate, Magnesium, Total Protein,<br>Triglycerides, and Uric Acid; Includes also,<br>Creatinine, Iron, Salicylate and Alkaline<br>Phosphatase (not value assigned analytes). |

# List of design inputs that are different between the two devices

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the predicate which is an existing multi calibrator already in commercial distribution with well established use and robustness. Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments.

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.

Public Health Service

Beckman Coulter, Inc. c/o Yvette Lloyd 250 S. Kraemer Blvd., Mail Stop: E2.SE.08 Brea, CA 92821

Re: k110251

Trade/Device Name: SYNCHRON Systems SYNCHRON Multi Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: Class II Product Code: JIX MAY 2 5 2011 Dated: 13 Apr 2011 Received: 15 Apr 2011

Dear: Ms. Lloyd,

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CPN Paul Sull [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

:沙

Enclosure

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Attachment A:

# Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ SYNCHRON® Systems SYNCHRON MULTI CALIBRATOR

Indications for Use:

The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Qus

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) ie 11025

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SYNCHRON Multi Calibrator Section 510(k) Supplemental Information, K110251 (Supp1)_04132011 11