SYSTEM CALIBRATER

K141388 · Beckman Coulter Ireland, Inc. · JIX · Jul 11, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141388
• Device Name: SYSTEM CALIBRATER
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 11, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.

Device Story

System Calibrator is a lyophilized human serum-based product containing chemical additives, preservatives, and enzymes of human, animal, and plant origin. It serves as a calibration reference for specific enzyme assays (ALP, ALT, AST, Amylase, CK-NAC, GGT, LDH) on Beckman Coulter AU480, AU680, and AU5800 clinical chemistry analyzers. The device is used in clinical laboratory settings by trained laboratory personnel. The calibrator is reconstituted and loaded onto the analyzer; the system uses the assigned calibrator values to adjust the instrument's response to reagent-analyte reactions, ensuring accurate quantitative determination of patient sample enzyme levels. This calibration process is essential for the clinical utility of the enzyme assays, enabling healthcare providers to make informed diagnostic and monitoring decisions based on reliable patient test results.

Clinical Evidence

Bench testing only. Stability studies (shelf life and open-vial) were conducted per CLSI EP25A on representative AU analyzer platforms. Value assignment was performed using 80 data points per reagent (10 replicates across 8 runs) to determine set points. No clinical data was required or provided.

Technological Characteristics

Lyophilized human serum matrix; contains chemical additives, preservatives, and enzymes. Designed for use on Beckman Coulter AU480, AU680, and AU5800 analyzers. Traceability to theoretical extinction coefficients. Stability: 36 months at 2-8°C (shelf life); 8 hours at 2-8°C (open vial).

Indications for Use

Indicated for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT, and LDH enzyme assays on Beckman Coulter AU480, AU680, and AU5800 clinical chemistry analyzers. For professional in vitro diagnostic use.

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.

Submission Summary (Full Text)

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## JUL 1 1 2014

141388

## 510k Summary System Calibrator

#### 1.0

## Submitted By:

Marguerita Sweeney Regulatory Affairs Manager Beckman Coulter Ireland, Inc. Lismeehan, O'Callaghan's Mills Co. Clare, Ireland Telephone: [phone] Fax: [phone] Email: [e-mail]

## Submitter Contact:

David Davis 250 S. Kraemer Blvd. E1. SE. 01 Brea California 92821, USA Telephone: [phone] Fax: [phone] Email:[e-mail]

#### 2.0 Date of preparation:

May 23rd, 2014

#### 3.0 Device Name(s):

Proprietary Names: System Calibrator Common Name: System Calibrator Classification: 862.1150 Product Code: JIX

#### 3.2 Classification Name Calibrator (21 CFR § 862.1150)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket Number |
|-------------------------|-----------------------------------------|-----------------|---------------|
| System Calibrator 66300 | SYNCHRON®<br>Enzyme Validator<br>441350 | Beckman Coulter | K951964 |

The System calibrator is substantially equivalent to the Beckman Coulter product listed above currently in commercial distribution.

#### 5.0 Description:

The System calibrator kit is a lyophilized human serum based product intended to provide calibration for AU Enzyme reagents (ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH) for the quantitative determination of the relevant analyte on Beckman Coulter AU analyzers.

The following is the kit configuration for the system calibrator: 66300 kit has 20 vials with 5 ml contents for Level 1.

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## :

The System calibrator is designed for optimal performance on Beckman Coulter AU analyzers.

The System calibrator contains lyophilized human serum with chemical additives, preservatives, and enzymes of human, animal and plant origin.

Biological materials of human origin contained in this product were tested for Anti-HCV, HbsAg and Anti-HIV 1/2 on a single donor basis using FDA approved methods and was found to be non-reactive. As there is no known test method that can offer complete assurance that products derived from human blood will not transmit infectious agents, this product should be handled as a potentially infectious material.

#### 6.0 Intended Use:

The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers.

For In Vitro Diagnostic use only.

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

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

| Similarities | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | System Calibrator | SYNCHRON® Enzyme Validator |
| Intended Use | The System Calibrator is a<br>calibration serum intended to be<br>used for the calibration of ALP,<br>ALT, AST, Amylase, CK-NAC,<br>GGT and LDH enzymes on<br>Beckman Coulter AU480, AU680<br>and AU5800 analysers. | The SYNCHRON Enzyme Validator<br>Set, in conjunction with specified<br>enzyme assays on SYNCHRON®<br>Systems, is intended<br>to provide points of reference in the<br>measurement of selected human<br>enzymes. |
| Analyte<br>Constituents | Alkaline Phosphatase<br>Alanine Aminotransferase<br>Amylase<br>Aspartate Aminotransferase<br>Creatinine Kinase<br>Gamma glutamyl transferase<br>Lactate Dehydrogenase | Alkaline Phosphatase<br>Alanine Aminotransferase<br>Amylase<br>Aspartate Aminotransferase<br>Creatinine Kinase<br>Cholinesterase<br>Gamma glutamyl transferase<br>Lipase<br>Lactate Dehydrogenase |
| Matrix Base | Human Serum | Human Serum |

-

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| Differences | | |
|---------------------------------|-------------------------------------|-------------------------------------------------------------------|
| Feature | System Calibrator | SYNCHRON® Enzyme Validator |
| Form | Lyophilized human serum | Liquid |
| Levels | 1 Level | 2 Levels |
| Volume | 20 x 5 ml | 3 x 5ml of each level/kit. |
| Storage (Closed/<br>Shelf Life) | 36 months | 16 months |
| Open Vial | 8 hours @ 2-8°C | 60 days @ -15°C - -20°C |
| Traceability | Theoretical Extinction Co-efficient | IFCC method, DGKCh method and<br>Manufacturers working calibrator |

## 8.0 Performance Characteristics summary report as per FDA guidance " Abbreviate 510 (k) submissions for In Vitro Diagnostic Calibrators"

8.1 Stability testing summary

Stability studies have been performed to determine the open vial stability and shelf life for this calibrator. For Open Vial and Shelf Life Stability studies. Beckman Coulter utilized internal test procedures from CLSI EP25A entitled "Evaluation of stability of In Vitro diagnostic reagents".

Open vial Testing was performed using 3 individual calibrator lots and multiple time points throughout the open vial stability claim period on a representative AU Clinical Chemistry analyzer platform.

At each time point the test vial was run with freshly opened calibrator vial. 2 Levels of an appropriate control material were used to control the runs. All were tested in replicated of 5 at each time point. A maximum allowable drift of ±5% was applied

Open Vial stability:

- · 8 hours @ 2-8°C
Shelf Life stability testing was carried out utilizing EP25A in order to support shelf life storage claim of 36 months when stored at 2-8℃. Shelf Life stability testing was performed on 3 individual lots of calibrator at multiple time points. All testing was conducted on a representative AU Clinical Chemistry analyzer platform with the associated reagent test system. A maximum allowable drift of ±5% was applied. To ensure robustness of the shelf life claim the shelf life period was tested for 36 months plus at least one month after expire date claim.

Shelf Life stability:

- · 36 months @ 2-8 ℃
## 7.1 Value Assignment Summary

Value assignment testing was performed utilizing internal procedures and protocols to determine values that will be used to calibrate AU enzyme reagents as per IFU on Beckman Coulter AU480/680/5800 Clinical chemistry analyzer platforms. Multiple reagent lots and calibrator vials

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were used to incorporate reagent and calibrator variation. 10 replicates from 8 runs were performed to give a total of 80 data points per each individual reagent. Distinct runs with minimum gaps of 2 hours were performed and 8 calibration events were used to incorporate variation from calibration and environmental sources. The overall mean was calculated for each individual enzyme and assigned as the calibrator set point.

#### 7.2 Traceability Summary

The System calibrator (66300) values were assigned using theoretical MB Factors. The calibration of each reagent is therefore traceable to the theoretical extinction coefficient as detailed on the individual reagent IFU's and in Table below:

| Product | Theoretical Extinction Co-efficient |
|-----------------|-------------------------------------|
| Amylase OSR6x06 | 11320 |
| ALP OSR6x04 | 17900 |
| ALT OSR6x07 | 4960 |
| AST OSR6x09 | 4960 |
| GGT OSR6x19 | 7453 |
| LDH OSR6x27 | 4960 |
| CK-NAC OSR6x79 | 6300 |

#### 8.0 Conclusion:

The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the System calibrator 66300 is as safe, as effective and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2014

## BECKMAN COULTER IRELAND INC DAVID DAVIS 250 S. KRAEMER BLVD. E1.SE.01 BREA CA 92821

Re: K141388

Trade/Device Name: System Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX Dated: May 23, 2014 Received: May 27, 2014

Dear Mr. David Davis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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-Mr. Davis

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

# Courtney H. Lias -S

Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.

510(k) Number (if known) k141388

Device Name System Calibrator

#### Indications for Use (Describe)

The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 andysers.

For In Vitro Diagnostic use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

#### FOR FDA USE ONLY

Concurrence of Carter for Devices and Radiological Haath (CDRH) (Signature)

## Yung W. Chan -S

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