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.

Device Description

Not Found

AI/ML Overview

The provided text describes the 510(k) summary for a Carbon Dioxide (CO2) measurement device, along with associated calibrators and controls. The study focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested details about acceptance criteria, ground truth, and AI-specific study designs are not applicable or extractable from this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the new device must meet to demonstrate clinical effectiveness. Instead, it aims to demonstrate substantial equivalence to an existing predicate device (Roche Diagnostics Corporation, model Hitachi 911 Roche Diagnostics Corporation item: CO2-L (Bicarbonate Liquid) (K032377)). The performance characteristics of the new device are presented in comparison to this predicate.

Implicit Acceptance Criteria (for Substantial Equivalence): The implicit acceptance criteria are that the new device's performance characteristics (intended use, indications for use, assay protocol, traceability, sample type, reagent storage, expected values, instrument compatibility, measuring range, precision, method comparison, and limitations) are sufficiently similar or equivalent to those of the predicate device, and that any differences do not raise new questions of safety or effectiveness.

Attribute	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (New Device #1 - Carbon Dioxide (CO2))
Intended Use	For in vitro diagnostic use in the quantitative determination of bicarbonate in human serum and plasma on Roche automated clinical chemistry analyzers.	For in vitro diagnostic use in the quantitative determination of the bicarbonate (CO2) concentration in human serum or plasma (Li-heparin) on T60 instrument.
Indication for Use	Bicarbonate measurements used in assessment of acid-base balance.	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.
Assay Protocol	Enzymatic rate	Enzymatic rate
Traceability/Standardization	Traceable to NIST	Traceable to RCPA AQAP Cycle 71
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)
Reagent Storage	Shelf life at 2 to 8 °C until the expiration date on cassette.	Reagents in unopened vials are stable at 2...8 °C until the expiry date printed on the label.
Expected Values	Adult: 22 - 29 mmol/L	Adult: 22 - 29 mmol/L
Instrument	Hitachi 911	T60 and DPC T60i, DPC T60i Kusti
Measuring Range	1.5 - 50 mmol/L	5 - 40 mmol/L
Precision (Within run)	Level 20.5 mmol/L: SD = 0.18, CV(%) = 0.9Level 34.4 mmol/L: SD = 0.19, CV(%) = 0.6	Level 15.7 mmol/L: SD = 0.3, CV(%) = 1.9Level 25.2 mmol/L: SD = 0.4, CV(%) = 1.6Level 34.3 mmol/L: SD = 0.4, CV(%) = 1.3
Precision (Between run)	Level 17.8 mmol/L: SD = 0.4, CV(%) = 2.5Level 29.8 mmol/L: SD = 0.5, CV(%) = 1.8	Level 15.7 mmol/L: SD = 0.8, CV(%) = 5.3Level 25.2 mmol/L: SD = 1.0, CV(%) = 3.9Level 34.3 mmol/L: SD = 1.5, CV(%) = 4.5
Precision (Total)	Not explicitly stated for predicate; implied by within/between run values.	Level 15.7 mmol/L: SD = 1.0, CV(%) = 6.1Level 25.2 mmol/L: SD = 1.2, CV(%) = 4.9Level 34.3 mmol/L: SD = 1.6, CV(%) = 4.7
Method Comparison (Regression Analysis)	Y = 1.01 x - 0.89, R = 0.998, Range 0.67 to 46 mmol/L, N = 59	Serum and plasma (Li-heparin): y = 0.978x + 1.23, R = 0.983, Range 9.1 to 49.5 mmol/L, N = 100Serum: y = 0.972x + 1.40, R = 0.9835, Range 9.1 to 49.5 mmol/L, N = 71Plasma (Li-heparin): y = 1.046x - 0.24, R = 0.9816, Range 11.4 to 45.2 mmol/L, N = 29
Limitations (Interference - Lipemia)	No significant interference up to an L index of 2000.	No interference found up to 2000 mg/dL (20 g/l) of Intralipid.
Limitations (Interference - Hemoglobin)	No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).	No interference found up to 1000 mg/dL (10 g/l) of hemoglobin.No interference found up to 400 mg/dL (4 g/l) of hemoglobin in hemolysate.
Limitations (Interference - Bilirubin)	No significant interference up to an I index of 60 for conjugated bilirubin and an I index of 50 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L; approximate unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L).	Bilirubin, conjugated: No interference found up to 60 mg/dL (1000 µmol/l) of conjugated bilirubin.Bilirubin, unconjugated: No interference found up to 60 mg/dL (1000 µmol/l) of unconjugated bilirubin.

Study Details:

Sample sizes used for the test set and the data provenance:
- Method Comparison Test Set:
  - Total samples: 100 (Serum and plasma (Li-heparin))
  - Sub-sets:
    - Serum: 71 samples
    - Plasma (Li-heparin): 29 samples
  - Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This information is typically not included in a 510(k) summary for in-vitro diagnostic devices unless specific clinical trials were performed in particular regions. It's likely from an in-house evaluation setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of IVD device. The "ground truth" for chemical analyzers is established through reference methods or highly calibrated instruments, not by expert interpretation. The performance is assessed by comparing results to a predicate device or by established analytical methods for precision and linearity.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), not for objective chemical measurements where results are quantitative values.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic measurement device. Its performance, as described in precision and method comparison, represents its "standalone" analytical capability. It does not involve an "algorithm" in the AI sense, but rather a chemical reaction and measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference for the method comparison was the predicate device (Roche Diagnostics Corporation CO2-L (Bicarbonate Liquid) on a Hitachi 911). Precision was evaluated using control materials. Traceability for the new device is to "RCPA AQAP Cycle 71" and for the predicate to "NIST," indicating standardized external reference materials or accreditation schemes.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. Its development involves chemical and engineering principles validated through analytical studies.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI-driven device.

Summary

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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 2P.O. Box 100FIN-01621 VantaaFinland
Phone:	+358 (9) 329 100 tel
Fax:	+358 (9) 3291 0300 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:

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

+358 (9) 329 100 tel +358 (9) 3291 0500 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 thequantitative determionation of thebicarbonate (CO2) concentration inhuman serum or plasma (Li-heparin)on T60 instrument.	In vitro test for the quantitativedetermination of bicarbonate inhuman serum and plasma onRoche automated clinicalchemistry analyzers.
Indication for Use	Carbon Dioxide (CO2) Reagent isintended for the quantitativedetermination of total carbondioxide in human serum.Bicarbonate measurements, inconjunction with tests such asglucose, urea, sodium, potassiumand chloride, are used in theassessment of disturbances of acidbase balance resulting frommetabolic 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 arestable at 2...8 °C until the expirydate printed on the label.	Shelf life at 2 to 8 °C until theexpiration 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/LSD= 0.3CV(%)= 1.9	Level 20.5 mmol/LSD = 0.18CV(%)= 0.9
	Level 25.2 mmol/LSD=0.4CV(%)= 1.6	Level 34.4 mmol/LSD = 0.19CV(%)= 0.6
	Level 34.3 mmol/LSD= 0.4CV(%)= 1.3	Between run
	Between run	Level 17.8 mmol/LSD = 0.4CV(%)= 2.5
	Level 15.7 mmol/LSD= 0.8CV(%)= 5.3	Level 29.8 mmol/LSD = 0.5CV(%)= 1.8
	Level 25.2 mmol/LSD= 1.0CV(%)= 3.9
	Level 34.3 mmol/LSD= 1.5CV(%)= 4.5
	Total
	Level 15.7 mmol/LSD= 1.0CV(%)= 6.1
	Level 25.2 mmol/LSD= 1.2CV(%)= 4.9
	Level 34.3 mmol/LSD= 1.6CV(%)= 4.7
Method Comparison	Serum and plasma (Li-heparin) :$y = 0.978x + 1.23$R = 0.983Range 9.1 to 49.5 mmol/LN = 100	$Y=1.01 x - 0.89$R = 0.998Range 0.67 to 46 mmol/LN = 59
	Serum:$y = 0.972x + 1.40$R = 0.9835Range 9.1 to 49.5 mmol/LN = 71
	Plasma (Li-heparin):$y = 1.046x - 0.24$R = 0.9816Range 11.4 to 45.2 mmol/LN = 29
Attribute	New device #1	Predicate device #1
Limitations	Lipemia:No interference found up to 2000mg/dL (20 g/l) of Intralipid.Hemoglobin:No interference found up to 1000mg/dL (10 g/l) of hemoglobin.Hemolysate:No interference found up to 400mg/dL (4 g/l) of hemoglobin inhemolysateBilirubin, conjugated:No interference found up to 60mg/dL (1000 µmol/l) of conjugatedbilirubin.Bilirubin, unconjugated:No interference found up to 60mg/dL (1000 µmol/l) ofunconjugated bilirubin.	Lipemia (Intralipid):No significant interference up toan L index of 2000.Hemolysate:No significant interference up toan H index of 1000 (approximatehemoglobin concentration: 1000mg/dL or 621 µmol/L).Bilirubin, conjugated /unconjugated:No significant interference up toan I index of 60 for conjugatedbilirubin and an I index of 50 forunconjugated bilirubin(approximate conjugated bilirubinconcentration: 60 mg/dL or 1026µmol/L; approximateunconjugated bilirubinconcentration: 50 mg/dL or 855µmol/L).

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

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+358 (9) 329 100 tel +358 (9) 3291 0500 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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.

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

Regulation Number and Section

§ 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.