BICARBONATE CALIBRATOR

K141374 · Beckman Coulter Ireland, Inc. · JIT · Jun 30, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141374
• Device Name: BICARBONATE CALIBRATOR
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 30, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyzers. For in vitro diagnostic use only.

Device Story

Bicarbonate Calibrator is a two-level aqueous sodium carbonate solution; used to calibrate bicarbonate reagent (OSR6x37) on Beckman Coulter AU clinical chemistry analyzers. Device provides reference values for instrument calibration; ensures accuracy of bicarbonate measurements in patient samples. Used in clinical laboratory settings by trained laboratory personnel. Output is a calibration curve or factor used by the analyzer to calculate bicarbonate concentrations in patient specimens. Benefits include standardized, accurate diagnostic testing for bicarbonate levels, aiding in clinical assessment of acid-base balance.

Clinical Evidence

Bench testing only. Stability studies (shelf life 13 months, open vial 30 days) performed per CLSI EP25A. Value assignment and traceability verified against NIST SRM351 standard. Precision and recovery met acceptance criteria (≤ 3% or SD ≤ 1mEq/L; ±5% deviation from target).

Technological Characteristics

Aqueous solution of sodium carbonate; contains sodium o-phenylphenate tetrahydrate as preservative. Two-level configuration. Traceable to NIST SRM351. Designed for use on Beckman Coulter AU series analyzers. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use as a calibrator for bicarbonate assays on Beckman Coulter AU clinical chemistry analyzers.

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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## JUN 3 0 2014

## 510k Summary Bicarbonate Calibrator

1.0

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

### SubmitterContact:

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

#### 2.0 Dateofpreparation:

May 230 2014

#### 3.0 Deviceldentification:

Proprietary Names: Bicarbonate Calibrator Common Name: Bicarbonate calibrator Classification: 862.1150 Product Code: JIT

#### 4.0 PredicateDevice:

| Candidate(s) | Predicate | Manufacturer | Docket Number |
|------------------------|--------------------------------------------|-----------------|---------------|
| Bicarbonate Calibrator | DR0070 Lyophilized<br>Chemistry calibrator | Beckman Coulter | K043460 |

The Bicarbonate Calibrator is substantially equivalent to the product listed above currently in commercial distribution

#### 5.0 Description:

The Bicarbonate Calibrator kit is a two level aqueous preparation of sodium carbonate intended to provide calibration for the Bicarbonate reagent for the calibration of bicarbonate on Beckman AU Coulter analyzers. This is available in the following configurations Cat # OSR6137, OSR6237 and OSR6537. For convenience this is often referred to internally and externally as OSR6x37.

The following is the kit configuration for the Bicarbonate Calibrator:

ODC0019 has 3 vials with 25ml contents for Level 1 and 3 vials with 25ml for Level 2.

The Bicarbonate Calibrator is designed for optimal performance on Beckman Coulter AU analyzers.

The calibrator contains sodium o-phenylphenate tetrahydrate which acts as a preservative. This ingredient is classified as a potential carcinogen and may cause irritation of the eyes, skin and mucous membranes. Product labeling carries the appropriate hazards and warnings.

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#### 6.0 IntendedUse:

The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyzers.

For in vitro diagnostic use only.

#### 7.0 ComparisontoPredicate(s):

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

| | Similarities | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature<br>Intended Use | Bicarbonate Calibrator ODC0019<br>The Bicarbonate calibrator is an<br>aqueous preparation of sodium<br>carbonate intended to be used<br>with the Bicarbonate reagent<br>OSR6x37 for the calibration of<br>bicarbonate on Beckman Coulter<br>AU analyzers. | Lyophilized Chemistry Calibrator<br>DR0070<br>Beckman Coulter Chemistry<br>Calibrators are intended for use<br>when calibrating methods run on<br>the Beckman Coulter AU series of<br>chemistry analyzers. |
| Levels | 2 Levels | 2 Levels |
| Traceability | The Bicarbonate calibrator<br>values are traceable to NIST<br>SRM351 | The assigned values for the<br>constituents are traceable to<br>reference materials from NIST. |

| Differences | | |
|----------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Bicarbonate Calibrator<br>ODC0019 | Lyophilized Chemistry Calibrator<br>DR0070 |
| Matrix Base | Aqueous | Human Serum |
| Analyte Constituents | Sodium carbonate | Albumin<br>Bicarbonate (C02)<br>Direct Bilirubin<br>Total Bilirubin<br>Calcium<br>Cholesterol<br>Creatinine<br>Glucose<br>Inorganic phosphorous<br>Iron Lactate<br>Magnesium<br>Total protein<br>Triglyceride<br>UIBC<br>Urea Nitrogen (BUN)<br>Uric acid |
| Form | Liquid | Lyophilized human serum with<br>diluent mixture |
| Volume | 3 x 25ml Level 1<br>3 x 25ml Level 2 | 12 x 5ml Level 1<br>12 x 6ml Diluent |

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| Volume | 3 x 25ml Level 1<br>3 x 25ml Level 2 | 12 x 5ml Level 1<br>12 x 6ml Diluent<br><br>12 x 5ml Level 2<br>12 x 6ml Diluent |
|---------------------------------|--------------------------------------|----------------------------------------------------------------------------------|
| Storage (Closed/ Shelf<br>Life) | 13 months | 36 months |
| Open Vial | 30 days @ 15-25°C | 3 days @ 2-8°C |

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

4.1 Stability testing summary - include EP25

> Stability studies have been performed to determine the open vial stability and shelf life for this calibrator. For Open Vial stability Beckman Coulter utilized internal test procedures from CLSI EP25A entitled "Evaluation of stability of In Vitro diagnostic reagents". 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. The controls were required to recover within target ranges and meet precision claims (≤ 3% or ≤3% or SD ≤1mEq/L).

Open Vial stability:

- 30 days @ 15-25°C .
Shelf Life stability testing was carried out utilizing EP25A in order to support shelf life storage claim of 13 months when stored at 15-25°C. Real time 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. The controls were required to recover within target ranges and meet precision claims (≤ 3% or ≤3% or SD ≤1mEq/L). To ensure robustness of the shelf life claim the shelf life period was tested for 13 months plus at least one month after expire date claim.

Shelf Life stability:

- 13 months @ 15-25°C .
#### 4.2 Value Assignment Summary

Verification of target values was performed on a representative AU Clinical chemistry analyzer platform. Testing was performed using one approved lot of DR0070 calibrator with OSR6x37 Bicarbonate reagent. The run is controlled with 3 levels of appropriate control material (n=5).

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A sample from test calibrator and NIST SRM 351 standard was run (n=10). A maximum allowable deviation of ±5% from assigned targets was applied.

#### 4.3 Traceability Summary

The Bicarbonate Calibrator is manufactured so that the values for the calibrator are traceable to NIST standard reference material SRM351. 2 levels NIST351 standard were prepared stoichimetrically as per certificate of analysis with a concentration of 20mEq/l and 40mEg/L. The bicarbonate calibrator is manufactured from commercially available high purity sodium carbonate and assigned a target value of 20mEq/L and 40mEq/L. Bicarbonate test system is calibrated with reference calibrator and the NIST351 standard and test calibrator recovered (n=10). A maximum allowable deviation of ±5% from assigned targets was applied.

#### 9.0 Conclusion:

The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Bicarbonate Calibrator ODC0019 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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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

June 30, 2014

BECKMAN COULTER IRELAND, INC C/O DAVID DA VIS 250 S. KRAEMER BLVD. EI. SE. 01 BREA CA 92821

Re: K141374

Trade/Device Name: Bicarbonate Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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/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 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.

Sincerely 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 below.

510(k) Number (if known) K141374

.

Devica Name Bicarbonate Calibrator

### Indications for Use (Describe)

The Bicarbonate Calibrator is an aqueous preparation of societe intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analysers. For in vitro diagnostic use only.

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

2 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 Center for Devices and Radiclogical Health (CDRH) (Signature)

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## Yung W. Chan -S

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