CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

K071340 · Thermofisher Scientific OY · KHS · Oct 5, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071340
• Device Name: CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
• Applicant: Thermofisher Scientific OY
• Product Code: KHS · Clinical Chemistry
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

Carbon dioxide (CO₂) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, potassium, and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes. sCal For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy. Nortrol For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy. Abtrol For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Device Story

Liquid, ready-to-use enzymatic reagent kit for quantitative CO2 determination; utilizes phosphoenolpyruvate (PEP) carboxylase methodology. Input: human serum or plasma samples. Process: bicarbonate ions react with PEP via PEPC to form oxaloacetate; malate dehydrogenase reduces oxaloacetate to malate, oxidizing NADH to NAD+. Output: spectrophotometric absorbance decrease at 380nm, proportional to CO2 concentration. Used in clinical chemistry laboratories on T60 analyzer; operated by trained laboratory personnel. Results assist clinicians in diagnosing and monitoring acid-base imbalances. Benefits include rapid, automated quantitative assessment of metabolic/respiratory status.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days (40 runs) using three reagent lots and three control levels; CVs ranged from 1.0% to 5.3%. Linearity established from 5.0–40.0 mmol/L. Method comparison with predicate (n=100 samples) showed correlation coefficients of 0.9825 (total) and Deming regression Y = 0.978X + 1.23. No clinical data.

Technological Characteristics

Liquid, ready-to-use enzymatic assay. Reagents: PEP (8.0 mM/L), NADH (1.6 mM/L), PEPC (>1000 U/L), MDH (>200 U/L), buffer (66 mmol/L), NaN3, stabilizers. Sensing principle: spectrophotometric absorbance at 380nm. Designed for T60 Clinical Chemistry Analyzer. Calibrators and controls are human-derived, tested negative for HIV-1/2, HBsAg, and HCV.

Indications for Use

Indicated for quantitative determination of total CO2 in human serum/plasma (Li-heparin) to assess acid-base balance disturbances (metabolic/respiratory) in conjunction with other electrolytes/metabolites.

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

• Roche Diagnostics/Hitachi Bicarbonate Liquid (k032377)

Submission Summary (Full Text)

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# OCT 5 2007

510(k) SUMMARY

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is:

is: K071340

#### A. Introduction:

According to the requirements of 21 CFR 807.92 the following information provides sufficent detail to understand the basis for a determination of substantial equivalence.

### B. Submitter's information

| Name: | Thermo Fisher Scientific Oy |
|----------------------|-----------------------------------------------------------|
| Address: | Ratastie 2<br>P.O. Box 100<br>FIN-01621 Vantaa<br>Finland |
| Phone: | [phone] tel |
| Fax: | [phone] fax |
| Contact person: | Päivi Sormunen, Vice President of QRC |
| Date of Preparation: | May 10th, 2007 |

#### ్ర Device name

| Proprietary name: | Carbon Dioxide (CO2) |
|-------------------|----------------------|
| Common name: | Carbon Dioxide (CO2) |
| Classification: | Clinical Chemistry |
| Class: | II |
| Product Code: | KHS |

Proprietary name: Common Name: Classification: Class: Product Code:

Proprietary name: Common Name: Classification: Class: Product Code:

Proprietary name: Common Name: Classification: Class: Product Code:

sCal, code 981831 Calibrator, Multi-Analyte Mixture Clinical Chemistry II JIX

Nortrol. code 981043 Multi-analyte Controls (Assayed and unassayed) Clinical Chemistry I

JJY

Abtrol, code 981044 Multi-analyte Controls (Assayed and unassayed) Clinical Chemistry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

JJY

Thermo Fisher Scientific Oy

[phone] tel [phone] fax

Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

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### D. Intended Use

Carbon Dioxide (CO2)

For in vitro diagnostic use in the quantitative determionation of the bicarbonate (CO2) concentration in human serum or plasma (Li-heparin) on T60 instrument

## sCal

For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

## Nortrol

For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

## Abtrol

For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

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#### E. Indications for use

Carbon Dioxide (CO2) Reagent is intended for the quantitative determination of total carbon dioxide in human serum. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, potassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes

For sCal Calibrator, Nortrol, Abtrol Controls see intended use

#### F. Substantial Equivalence

Roche Diagnostics Corporation, model Hitachi 911 Roche Diagnostics Corporation item: CO2-L (Bicarbonate Liquid) (K032377).

#### G. Substantial equivalence -similarities

The Carbon Dioxide (CO2) is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Roche Diagnostics Corporation CO2-L (Bicarbonate Liquid).

Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

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| The following table compares the Carbon Dioxide (CO2) with the predicate device. | | |
|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table 1 | | |
| Attribute | New device #1 | Predicate device #1 |
| Intended Use | For in vitro diagnostic use in the<br>quantitative determionation of the<br>bicarbonate (CO2) concentration in<br>human serum or plasma (Li-heparin)<br>on T60 instrument. | In vitro test for the quantitative<br>determination of bicarbonate in<br>human serum and plasma on<br>Roche automated clinical<br>chemistry analyzers. |
| Indication for Use | Carbon Dioxide (CO2) Reagent is<br>intended for the quantitative<br>determination of total carbon<br>dioxide in human serum.<br>Bicarbonate measurements, in<br>conjunction with tests such as<br>glucose, urea, sodium, potassium<br>and chloride, are used in the<br>assessment of disturbances of acid<br>base balance resulting from<br>metabolic or respiratory causes. | See intended use. |
| Assay Protocol | Enzymatic rate | Enzymatic rate |
| Traceability/Standardization | Traceable to RCPA AQAP Cycle 71 | Traceable to NIST |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin) |
| Reagent Storage | Reagents in unopened vials are<br>stable at 2...8 °C until the expiry<br>date printed on the label. | Shelf life at 2 to 8 °C until the<br>expiration date on cassette. |
| Expected Values | Adult: 22 - 29 mmol/L | 22 - 29 mmol/L |
| Instrument | T60 and DPC T60i, DPC T60i Kusti | Hitachi 911 |
| Measuring Range | 5 - 40 mmol/L | 1.5 - 50 mmol/L |
| Attribute | New device #1 | Predicate device #1 |
| Precision | | |
| | Within run | Within run |
| | Level 15.7 mmol/L<br>SD= 0.3<br>CV(%)= 1.9 | Level 20.5 mmol/L<br>SD = 0.18<br>CV(%)= 0.9 |
| | Level 25.2 mmol/L<br>SD=0.4<br>CV(%)= 1.6 | Level 34.4 mmol/L<br>SD = 0.19<br>CV(%)= 0.6 |
| | Level 34.3 mmol/L<br>SD= 0.4<br>CV(%)= 1.3 | Between run |
| | Between run | Level 17.8 mmol/L<br>SD = 0.4<br>CV(%)= 2.5 |
| | Level 15.7 mmol/L<br>SD= 0.8<br>CV(%)= 5.3 | Level 29.8 mmol/L<br>SD = 0.5<br>CV(%)= 1.8 |
| | Level 25.2 mmol/L<br>SD= 1.0<br>CV(%)= 3.9 | |
| | Level 34.3 mmol/L<br>SD= 1.5<br>CV(%)= 4.5 | |
| | Total | |
| | Level 15.7 mmol/L<br>SD= 1.0<br>CV(%)= 6.1 | |
| | Level 25.2 mmol/L<br>SD= 1.2<br>CV(%)= 4.9 | |
| | Level 34.3 mmol/L<br>SD= 1.6<br>CV(%)= 4.7 | |
| Method Comparison | Serum and plasma (Li-heparin) :<br>$y = 0.978x + 1.23$<br>R = 0.983<br>Range 9.1 to 49.5 mmol/L<br>N = 100 | $Y=1.01 x - 0.89$<br>R = 0.998<br>Range 0.67 to 46 mmol/L<br>N = 59 |
| | Serum:<br>$y = 0.972x + 1.40$<br>R = 0.9835<br>Range 9.1 to 49.5 mmol/L<br>N = 71 | |
| | Plasma (Li-heparin):<br>$y = 1.046x - 0.24$<br>R = 0.9816<br>Range 11.4 to 45.2 mmol/L<br>N = 29 | |
| Attribute | New device #1 | Predicate device #1 |
| Limitations | Lipemia:<br>No interference found up to 2000<br>mg/dL (20 g/l) of Intralipid.<br><br>Hemoglobin:<br>No interference found up to 1000<br>mg/dL (10 g/l) of hemoglobin.<br><br>Hemolysate:<br>No interference found up to 400<br>mg/dL (4 g/l) of hemoglobin in<br>hemolysate<br><br>Bilirubin, conjugated:<br>No interference found up to 60<br>mg/dL (1000 µmol/l) of conjugated<br>bilirubin.<br><br>Bilirubin, unconjugated:<br>No interference found up to 60<br>mg/dL (1000 µmol/l) of<br>unconjugated bilirubin. | Lipemia (Intralipid):<br>No significant interference up to<br>an L index of 2000.<br><br>Hemolysate:<br>No significant interference up to<br>an H index of 1000 (approximate<br>hemoglobin concentration: 1000<br>mg/dL or 621 µmol/L).<br><br>Bilirubin, conjugated /<br>unconjugated:<br>No significant interference up to<br>an I index of 60 for conjugated<br>bilirubin and an I index of 50 for<br>unconjugated bilirubin<br>(approximate conjugated bilirubin<br>concentration: 60 mg/dL or 1026<br>µmol/L; approximate<br>unconjugated bilirubin<br>concentration: 50 mg/dL or 855<br>µmol/L). |

·

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

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[phone] tel [phone] fax Y-tunnus 0921547-0
VAT No FI09215470 Domicile Helsinki

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three streams flowing from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific c/o Ms. Paivi Sormunen Vice President of Industrial Solutions and QRC Clinical Diagnostics Finland Ratastie 2, P.O. Box 100 FIN-01621 Vantaa, Finland

OCT 5 2007

k071340 Re:

> Trade Name: Carbon Dioxide (CO2), sCAL, Nortrol, Abtrol Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS, JIX, JJY Dated: September 4, 2007 Received: September 6, 2007

Dear Mr. Sormunen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permite your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 80 97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number: K071340

Device Names: Carbon Dioxide (CO2) sCal Nortrol Abtrol

## Indications for Use:

Carbon Dioxide (CO2)

Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer.

Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes

## sCal

For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Over

## Nortrol

For in vitro diagnostic use for quantitative testing on T60 analyzer.

Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

## Abtrol

For in vitro diagnostic use for quantitative testing on T60 analyzer.

Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Prescription Use X (21 CFR Part 801 Subpart D)

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

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-C Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K071340