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 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.

AI/ML Overview

The provided text describes the acceptance criteria and the study for the Beckman Coulter Bicarbonate Calibrator.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Open Vial Stability	Support claim of 30 days @ 15-25°C. Controls within target range & precision claims (≤ 3% or SD ≤1mEq/L).	30 days @ 15-25°C. Testing performed with 3 calibrator lots, multiple time points. Controls recovered within target ranges and met precision claims (≤ 3% or SD ≤1mEq/L). (Specific numerical data not provided, but overall claim supported).
Shelf Life Stability	Support claim of 13 months @ 15-25°C. Controls within target range & precision claims (≤ 3% or SD ≤1mEq/L).	13 months @ 15-25°C. Real-time stability testing on 3 lots at multiple time points. Controls recovered within target ranges and met precision claims (≤ 3% or SD ≤1mEq/L). Tested for 13 months plus at least one month after expiration. (Specific numerical data not provided, but overall claim supported).
Value Assignment	Maximum allowable deviation of ±5% from assigned targets.	Test calibrator and NIST SRM 351 standard run (n=10). (Specific numerical deviations not provided, but the criterion was applied).
Traceability	Maximum allowable deviation of ±5% from assigned targets.	NIST351 standard and test calibrator recovered (n=10) when tested with reference calibrator. (Specific numerical deviations not provided, but the criterion was applied).

2. Sample Size and Data Provenance

Test Set Sample Size:
- Stability Studies: Open vial and shelf life stability used "3 individual calibrator lots" for testing. "Multiple time points" were used during the claim period and beyond. For each time point, controls were run in "replicates of 5" and test vials were compared with "freshly opened calibrator vial."
- Value Assignment and Traceability: "A sample from test calibrator and NIST SRM 351 standard was run (n=10)." and "NIST351 standard and test calibrator recovered (n=10)."
Data Provenance: The studies were conducted by Beckman Coulter Ireland, Inc. and Beckman Coulter in the USA. The data appears to be prospective as it involves real-time stability testing and direct experimental runs for value assignment and traceability. No specific mention of country of origin for patients or samples, as this is a calibrator, not a diagnostic device using patient samples directly.

3. Number of Experts and Qualifications

Not applicable. This device is a calibrator, not a medical imaging device or algorithm requiring expert interpretation of results. The performance is assessed against analytical standards and established methods, not human expert consensus on clinical data.

4. Adjudication Method

Not applicable. This is an analytical device for calibration, not a diagnostic device requiring adjudication of clinical interpretations. Performance is determined by quantitative analytical results meeting predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a calibrator, not a diagnostic device that humans would interpret with or without AI assistance.

6. Standalone Performance Study

Yes, the studies described above are standalone performance studies of the calibrator itself. The calibrator's performance (stability, value assignment, traceability) is assessed independently of a human operator making clinical decisions. The calibrator's function is to ensure the accuracy of the Beckman Coulter AU analyzers when running the Bicarbonate reagent.

7. Type of Ground Truth Used

Stability Studies: The ground truth is the performance of the calibrator itself over time, compared to its initial established values and against the performance of freshly opened calibrator vials or within predefined control ranges and precision claims. The "appropriate control material" with "target ranges and precision claims" serves as a reference.
Value Assignment and Traceability: The ground truth is established by the NIST (National Institute of Standards and Technology) SRM351 standard. This is a highly accurate, internationally recognized reference material for bicarbonate. The calibrator's values are directly traced to this gold standard.

8. Sample Size for the Training Set

Not applicable. This is a chemical calibrator for in vitro diagnostics, not a machine learning or AI algorithm that requires a training set. Its formulation is based on chemical principles and manufacturing processes, not data training.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is used for this type of device.

Summary

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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: +353-65-683-1495 Fax: +353-65-683-1122 Email: msweeney@beckman.com

SubmitterContact:

David Davis 250 S. Kraemer Blvd. E1. SE. 01 Brea California 92821, USA Telephone: (469) 236-8180 Fax: (714) 961-4234 Email:dgdavis@beckman.com

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 LyophilizedChemistry calibrator	Beckman Coulter	K043460

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

5.0 Description:

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
FeatureIntended Use	Bicarbonate Calibrator ODC0019The Bicarbonate calibrator is anaqueous preparation of sodiumcarbonate intended to be usedwith the Bicarbonate reagentOSR6x37 for the calibration ofbicarbonate on Beckman CoulterAU analyzers.	Lyophilized Chemistry CalibratorDR0070Beckman Coulter ChemistryCalibrators are intended for usewhen calibrating methods run onthe Beckman Coulter AU series ofchemistry analyzers.
Levels	2 Levels	2 Levels
Traceability	The Bicarbonate calibratorvalues are traceable to NISTSRM351	The assigned values for theconstituents are traceable toreference materials from NIST.

Differences
Feature	Bicarbonate CalibratorODC0019	Lyophilized Chemistry CalibratorDR0070
Matrix Base	Aqueous	Human Serum
Analyte Constituents	Sodium carbonate	AlbuminBicarbonate (C02)Direct BilirubinTotal BilirubinCalciumCholesterolCreatinineGlucoseInorganic phosphorousIron LactateMagnesiumTotal proteinTriglycerideUIBCUrea Nitrogen (BUN)Uric acid
Form	Liquid	Lyophilized human serum withdiluent mixture
Volume	3 x 25ml Level 13 x 25ml Level 2	12 x 5ml Level 112 x 6ml Diluent

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Volume	3 x 25ml Level 13 x 25ml Level 2	12 x 5ml Level 112 x 6ml Diluent12 x 5ml Level 212 x 6ml Diluent
Storage (Closed/ ShelfLife)	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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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 UseForm 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)

...

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. 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)

Yung W. Chan -S

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The burden time for this collection of information is estimated to average 79 hours par response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (1/14)

Page 1 of 1

: IC Publishing tiers and (10) 401-6740

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.