AU BICARBONATE REAGENT

K131546 · Beckman Coulter Ireland, Inc. · KHS · Oct 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131546
• Device Name: AU BICARBONATE REAGENT
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Oct 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. For in vitro diagnostic use.

Device Story

Liquid, ready-to-use reagent kit for quantitative Bicarbonate measurement; utilizes enzymatic photometric method on Beckman Coulter AU5800 analyzers. Input: human serum or plasma samples. Principle: Bicarbonate and phosphoenolpyruvate (PEP) converted to oxaloacetate and malate via microbial enzymes; reaction involves oxidation of NADH, causing absorbance decrease at 380/410 nm. Output: quantitative Bicarbonate concentration (mEq/L). Used in clinical laboratory settings by trained technicians. Output assists clinicians in assessing patient acid-base status and diagnosing metabolic disorders. Benefits: provides rapid, automated diagnostic data for clinical decision-making regarding electrolyte and acid-base management.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (N=80, N=15). Linearity (r2=0.99979) and LoQ (1.95 mEq/L) established per CLSI EP06-A and EP17-A2. Method comparison with predicate (N=129) yielded r2=0.9910. Matrix comparison (N=41) confirmed performance across serum, lithium heparin, and sodium heparin plasma. Interference testing performed for lipids, hemolysis, bilirubin, and ascorbic acid.

Technological Characteristics

Liquid, ready-to-use enzymatic reagent. Principle: Enzymatic photometric (NADH oxidation). Measurement: Bichromatic absorbance at 380/410nm. Calibration: Serum-based, NIST-traceable. Designed for Beckman Coulter AU analyzers. Stability: 7 days refrigerated on-board.

Indications for Use

Indicated for quantitative determination of bicarbonate in human serum and plasma to assist in diagnosis and treatment of disorders associated with acid-base balance changes.

Regulatory Classification

Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Predicate Devices

• Trace America, Carbon Dioxide - DST (k960035)

Submission Summary (Full Text)

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# 546

OCT 0 9 2013

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved white lines inside, resembling a stylized eye. To the right of the circle are the words "BECKMAN" stacked on top of "COULTER", both in a bold, sans-serif font.

## 510k Summary AU Bicarbonate Reagent

#### 1.0 Submitted By:

David G. Davis Director Regulatory Affairs Beckman Coulter Inc. 250 S. Kraemer Boulevard Brea, CA 92821. Telephone: [phone] Fax: [phone] Email: [e-mail]

**Date Submitted:**

April 24, 2013

#### 3.0 Device Name(s):

2.0

### 3.1 Proprietary Names AU Bicarbonate Reagent

#### 3.2 Classification Name

Bicarbonate/carbon dioxide test system (21 CFR § 862.1160)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket Number |
|------------------------|----------------------|--------------|---------------|
| AU Bicarbonate Reagent | Carbon Dioxide - DST | Trace | K960035 |

#### 5.0 Description:

The AU Bicarbonate reagent kit is a liquid, ready to use and consists of four R1 reagent vials in vanous fill volumes. The calibrator is a Beckman Coulter lyophilized chemistry calibrator packaged as catalog number DR0070 and sold separately. The AU Bicarbonate reagent is an enzymatic method utilizing Bicarbonate (HCO3) and phosphoenolpyruvate (PEP), which are converted to oxaloacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). This oxidation of NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410nm proportional to the Bicarbonate content of the sample.

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

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#### 6.0 Intended Use:

AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance.

For in vitro diagnostic use.

### Clinical Significance

Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance.

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

The following tables shows similarities and differences between the predicate identified in Section 4.0 of this summary. 1 T

| | Similarities | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | AU Bicarbonate Reagent | Predicate |
| Intended Use | System reagent for the quantitative<br>determination of Bicarbonate in<br>human serum and plasma on<br>Beckman Coulter AU analyzers. | Similar<br>This reagent is intended for in vitro<br>quantitative determination of total<br>carbon dioxide in human serum on<br>both automated and manual<br>systems. |
| Measurement | Quantitative | Same |
| Reagent | Liquid, Ready for use | Same |
| Assay<br>Methodology/O<br>perating<br>Principle | Enzymatic Photometric | Same |
| Calibration | Serum based calibrator traceable to<br>NIST standard<br>(Cat #DR0070) | Similar<br>Recommended to use an aqueous<br>or serum based calibrator traceable<br>to a primary standard (e.g. NIST or<br>IRMM) |
| Linearity Range | 2.0 - 45.0 mEq/L | Similar<br>3 - 50 mEq/L |
| Expected<br>Values | 23 - 29 mEq/L | Same<br>23.0 - 29.0 mEq/L |

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| Differences | | |
|----------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Feature | AU Bicarbonate Reagent | Predicate |
| Instrumentation | Beckman Coulter AU Analyzers | Automated and manual systems |
| Specimen Type | Serum and Plasma<br>(Sodium Heparin and Lithium Heparin) | Serum |
| Reagent On Board Stability | Opened reagents are stable for seven days when stored in the refrigerated compartment of the analyzer | Not specified |
| Calibration Frequency | Daily | Not specified |
| Sensitivity | LoB = 1.20 mEq/L<br>LoD = 1.95 mEq/L | Analytical 0.01 ΔA per mEq/L |
| Interfering Substances | Unconjugated Bilirubin:<br>No significant interference up to 40 mg/dL | Unconjugated Bilirubin:<br>No interference up to 18.6 mg/dL |
| | Conjugated Bilirubin:<br>No significant interference up to 20 mg/dL | Conjugated Bilirubin:<br>No interference up to 18.7 mg/dL |
| | Hemolysis:<br>No significant interference up to 500 mg/dL | Haemoglobin:<br>No interference up to 520 mg/dL |
| | Lipemia:<br>No significant interference up to 1000 mg/dL Intralipid | Lipemia:<br>No interference measured at absorbance 630 nm, up to 1.77 AU |
| | No significant interference is recovery within 10% of initial value | |

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to a predicate chemistry test systems already in commercial distribution. Equivalence is demonstrated through performance characteristics testing. Experiments included: Method Comparison, Precision, Linearity, Sensitivity, Interferences, Stability and Expected Values, as outlined in FDA's guidance entitled "In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System."

Performance on method comparison and precision are summarized below:

| Reference | Test | Sample<br>Range: | Specifications | Results | Pass/<br>Fail |
|-----------------------------------|-----------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------|
| Thermo<br>Scientific<br>(TR28321) | AU Bicarbonate<br>(OSR6x37) | Ref:<br>5.63 mEq/L -<br>45.44 mEq/L<br>Test:<br>4.69 mEq/L -<br>41.85 mEq/L | Slope:<br>0.900-1.100<br>Intercept:<br>±2.0mEq/L<br>r: ≥ 0.95<br>N: >100 | Slope: 0.922<br>Intercept:<br>1.148mEq/L<br>r: 0.9909<br>N: 133 | Pass<br>Pass<br>Pass<br>Pass |

Method Comparison Study Results

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| Sample | Concentration<br>mEq/L | Within run precision | | Total precision | | | Pass/<br>Fail | |
|--------------|------------------------|----------------------|------|------------------|-----|------|--------------------------|------|
| | | %CV | SD | Specification | %CV | SD | Specification | |
| Low<br>pool | 12.3 | 2.5 | 0.30 | ≤3%CV<br>or SD≤1 | 7.5 | 0.92 | ≤7%CV or SD<br>≤1.5mEq/L | Pass |
| Med<br>pool | 31.0 | 1.1 | 0.35 | ≤3%CV<br>or SD≤1 | 4.0 | 1.23 | ≤7%CV or SD<br>≤1.5mEq/L | Pass |
| High<br>pool | 40.3 | 0.8 | 0.34 | ≤3%CV<br>or SD≤1 | 3.6 | 1.47 | ≤7%CV or SD<br>≤1.5mEq/L | Pass |

Precision Study Results

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

October 9, 2013

Beckman Coulter Ireland, Inc. c/o David G. Davis 250 S. Kraemer Blvd. BREA CA 92821

Re: K131546

Trade/Device Name: AU Bicarbonate Reagent Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: II Product Code: KHS Dated: August 21, 2013 Received: August 29, 2013

Dear Mr. 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 conceming 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 Small Manufacturers, International and Construction Assistance 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" (21CFR 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -S for

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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## Indications for Use

510(k) Number: k131546

Device Name: AU Bicarbonate Reagent

Indications for Use: AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

For In Vitro Diagnostic Use

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Yung ADAhan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

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