(144 days)
Not Found
No
The summary describes a reagent and calibrators for a clinical chemistry analyzer, focusing on quantitative measurements and performance characteristics like precision and method comparison. There is no mention of AI or ML.
No
The device is an in vitro diagnostic reagent intended for the quantitative determination of total carbon dioxide in human serum and plasma, which is used for diagnostic purposes rather than therapy.
Yes
The document explicitly states that the CO2 reagent is "intended for the quantitative determination of total carbon dioxide in human serum and plasma" and that "Bicarbonate measurements... are used in the assessment of disturbances of acid base balance." This indicates its use in diagnosing medical conditions. Additionally, the sCal, Nortrol, and Abtrol products are stated to be "For in vitro diagnostic use."
No
The device described is a reagent for use on a specific analyzer (T60). Reagents are chemical substances, not software. The summary also describes performance studies related to the chemical analysis, not software performance.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma. This analysis is performed in vitro (outside the body) on biological samples.
- Clinical Purpose: The intended use also mentions that these measurements are used in the assessment of disturbances of acid-base balance, which is a clinical diagnostic purpose.
- Calibrators and Controls: The descriptions for sCal, Nortrol, and Abtrol all explicitly state "For in vitro diagnostic use". These are essential components used in the process of performing the diagnostic test.
- Performance Data: The inclusion of performance data like precision and method comparison, along with limitations, is typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K032377; Roche Diagnostics Corporation item: CO2-L (Bicarbonate Liquid)) which is also a CO2 reagent, strongly suggests that this device is intended for the same diagnostic purpose and regulatory pathway as its predicate, which is an IVD.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
KHS, JIX, JJY
Device Description
Not Found
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)
Method Comparison
Serum and plasma (Li-heparin) :
y = 0.978x + 1.23
R = 0.983
Range 9.1 to 49.5 mmol/L
N = 100
Serum:
y = 0.972x + 1.40
R = 0.9835
Range 9.1 to 49.5 mmol/L
N = 71
Plasma (Li-heparin):
y = 1.046x - 0.24
R = 0.9816
Range 11.4 to 45.2 mmol/L
N = 29
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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 |
| P.O. Box 100 | |
| FIN-01621 Vantaa | |
| Finland | |
| 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:
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
+358 (9) 329 100 tel +358 (9) 3291 0500 fax
Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki
1
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.
2
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
3
| 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 | |
| quantitative determionation of the | ||
| bicarbonate (CO2) concentration in | ||
| human serum or plasma (Li-heparin) | ||
| on T60 instrument. | In vitro test for the quantitative | |
| determination of bicarbonate in | ||
| human serum and plasma on | ||
| Roche automated clinical | ||
| chemistry analyzers. | ||
| Indication 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. | 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 | |
| stable at 2...8 °C until the expiry | ||
| date printed on the label. | Shelf life at 2 to 8 °C until the | |
| 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 | ||
| SD= 0.3 | ||
| CV(%)= 1.9 | Level 20.5 mmol/L | |
| SD = 0.18 | ||
| CV(%)= 0.9 | ||
| Level 25.2 mmol/L | ||
| SD=0.4 | ||
| CV(%)= 1.6 | Level 34.4 mmol/L | |
| SD = 0.19 | ||
| CV(%)= 0.6 | ||
| Level 34.3 mmol/L | ||
| SD= 0.4 | ||
| CV(%)= 1.3 | Between run | |
| Between run | Level 17.8 mmol/L | |
| SD = 0.4 | ||
| CV(%)= 2.5 | ||
| Level 15.7 mmol/L | ||
| SD= 0.8 | ||
| CV(%)= 5.3 | Level 29.8 mmol/L | |
| SD = 0.5 | ||
| CV(%)= 1.8 | ||
| Level 25.2 mmol/L | ||
| SD= 1.0 | ||
| CV(%)= 3.9 | ||
| Level 34.3 mmol/L | ||
| SD= 1.5 | ||
| CV(%)= 4.5 | ||
| Total | ||
| Level 15.7 mmol/L | ||
| SD= 1.0 | ||
| CV(%)= 6.1 | ||
| Level 25.2 mmol/L | ||
| SD= 1.2 | ||
| CV(%)= 4.9 | ||
| Level 34.3 mmol/L | ||
| SD= 1.6 | ||
| CV(%)= 4.7 | ||
| Method Comparison | Serum and plasma (Li-heparin) : | |
| $y = 0.978x + 1.23$ | ||
| R = 0.983 | ||
| Range 9.1 to 49.5 mmol/L | ||
| N = 100 | $Y=1.01 x - 0.89$ | |
| R = 0.998 | ||
| Range 0.67 to 46 mmol/L | ||
| N = 59 | ||
| Serum: | ||
| $y = 0.972x + 1.40$ | ||
| R = 0.9835 | ||
| Range 9.1 to 49.5 mmol/L | ||
| N = 71 | ||
| Plasma (Li-heparin): | ||
| $y = 1.046x - 0.24$ | ||
| R = 0.9816 | ||
| Range 11.4 to 45.2 mmol/L | ||
| N = 29 | ||
| Attribute | New device #1 | Predicate device #1 |
| Limitations | Lipemia: | |
| No interference found up to 2000 | ||
| mg/dL (20 g/l) of Intralipid. |
Hemoglobin:
No interference found up to 1000
mg/dL (10 g/l) of hemoglobin.
Hemolysate:
No interference found up to 400
mg/dL (4 g/l) of hemoglobin in
hemolysate
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. | Lipemia (Intralipid):
No significant interference up to
an L index of 2000.
Hemolysate:
No significant interference up to
an H index of 1000 (approximate
hemoglobin concentration: 1000
mg/dL or 621 µmol/L).
Bilirubin, conjugated /
unconjugated:
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). |
·
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
4
1
5
+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0
VAT No FI09215470 Domicile Helsinki
6
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.
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