(133 days)
Not Found
No
The device description details a standard enzymatic chemical reaction for measuring bicarbonate, and the performance studies focus on traditional analytical chemistry metrics like method comparison and precision. There is no mention of AI, ML, or any computational analysis beyond basic data processing of absorbance measurements.
No.
The device is for in vitro diagnostic use, specifically for quantitative determination of Bicarbonate in human serum and plasma to aid in diagnosis, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative determination of Bicarbonate in human serum and plasma" and that "Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This indicates its role in providing diagnostic information.
No
The device is a reagent kit for in vitro diagnostic use, which is a chemical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for the quantitative determination of Bicarbonate in human serum and plasma. This is a test performed on biological samples outside of the body to provide information for diagnosis and treatment.
- Device Description: The description details a reagent kit used in a laboratory setting on an analyzer to perform a chemical reaction on a sample.
- Performance Studies: The document describes performance studies like Method Comparison and Precision, which are standard for validating IVD devices.
- Predicate Device: A predicate device (K960035; Carbon Dioxide - DST) is listed, which is another IVD device.
All of these points strongly indicate that the AU Bicarbonate reagent is an In Vitro Diagnostic device.
N/A
Intended Use / 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 acidbase balance.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
KHS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Method Comparison Study Results:
Reference: Thermo Scientific (TR28321)
Test: AU Bicarbonate (USR6x37)
Sample Range: Ref: 5.63 mEq/L - 45.44 mEq/L, Test: 4.69 mEq/L - 41.85 mEq/L
Specifications: Slope: 0.900-1.100, Intercept: +/-2.0mEq/L, r: >= 0.95, N: >100
Results: Slope: 0.922, Intercept: 1.148mEq/L, r: 0.9909, N: 133
Pass/Fail: Pass, Pass, Pass, Pass
Precision Study Results:
Sample: Low pool
Concentration mEq/L: 12.3
Within run precision %CV: 2.5
Within run precision SD: 0.30
Within run precision Specification:
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
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.(b)
Classification. Class II.
0
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: (469) 236-8180 Fax: (714) 961-4234 Email: dgdavis@beckman.com
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.
1
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 | |
| determination of Bicarbonate in | ||
| human serum and plasma on | ||
| Beckman Coulter AU analyzers. | Similar | |
| This reagent is intended for in vitro | ||
| quantitative determination of total | ||
| carbon dioxide in human serum on | ||
| both automated and manual | ||
| systems. | ||
| Measurement | Quantitative | Same |
| Reagent | Liquid, Ready for use | Same |
| Assay | ||
| Methodology/O | ||
| perating | ||
| Principle | Enzymatic Photometric | Same |
| Calibration | Serum based calibrator traceable to | |
| NIST standard | ||
| (Cat #DR0070) | Similar | |
| Recommended to use an aqueous | ||
| or serum based calibrator traceable | ||
| to a primary standard (e.g. NIST or | ||
| IRMM) | ||
| Linearity Range | 2.0 - 45.0 mEq/L | Similar |
| 3 - 50 mEq/L | ||
| Expected | ||
| Values | 23 - 29 mEq/L | Same |
| 23.0 - 29.0 mEq/L |
2
| Differences | ||
|---|---|---|
| Feature | AU Bicarbonate Reagent | Predicate |
| Instrumentation | Beckman Coulter AU Analyzers | Automated and manual systems |
| Specimen Type | Serum and Plasma | |
| (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 | |
| LoD = 1.95 mEq/L | Analytical 0.01 ΔA per mEq/L | |
| Interfering Substances | Unconjugated Bilirubin: | |
| No significant interference up to 40 mg/dL | Unconjugated Bilirubin: | |
| No interference up to 18.6 mg/dL | ||
| Conjugated Bilirubin: | ||
| No significant interference up to 20 mg/dL | Conjugated Bilirubin: | |
| No interference up to 18.7 mg/dL | ||
| Hemolysis: | ||
| No significant interference up to 500 mg/dL | Haemoglobin: | |
| No interference up to 520 mg/dL | ||
| Lipemia: | ||
| No significant interference up to 1000 mg/dL Intralipid | Lipemia: | |
| 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
Range: | Specifications | Results | Pass/
Fail |
|-----------------------------------|-----------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------|
| Thermo
Scientific
(TR28321) | AU Bicarbonate
(OSR6x37) | Ref:
5.63 mEq/L -
45.44 mEq/L
Test:
4.69 mEq/L -
41.85 mEq/L | Slope:
0.900-1.100
Intercept:
±2.0mEq/L
r: ≥ 0.95
N: >100 | Slope: 0.922
Intercept:
1.148mEq/L
r: 0.9909
N: 133 | Pass
Pass
Pass
Pass |
Method Comparison Study Results
3
| Sample | Concentration
mEq/L | Within run precision | | Total precision | | | Pass/
Fail | |
|--------------|------------------------|----------------------|------|------------------|-----|------|--------------------------|------|
| | | %CV | SD | Specification | %CV | SD | Specification | |
| Low
pool | 12.3 | 2.5 | 0.30 | ≤3%CV
or SD≤1 | 7.5 | 0.92 | ≤7%CV or SD
≤1.5mEq/L | Pass |
| Med
pool | 31.0 | 1.1 | 0.35 | ≤3%CV
or SD≤1 | 4.0 | 1.23 | ≤7%CV or SD
≤1.5mEq/L | Pass |
| High
pool | 40.3 | 0.8 | 0.34 | ≤3%CV
or SD≤1 | 3.6 | 1.47 | ≤7%CV or SD
≤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.
Section 5 - Page 4 of 4
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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.
5
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
6
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
510(k) and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the first of t