Search Results

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(%) = 0.9
Level 34.4 mmol/L: SD = 0.19, CV(%) = 0.6	Level 15.7 mmol/L: SD = 0.3, CV(%) = 1.9
Level 25.2 mmol/L: SD = 0.4, CV(%) = 1.6
Level 34.3 mmol/L: SD = 0.4, CV(%) = 1.3
Precision (Between run)	Level 17.8 mmol/L: SD = 0.4, CV(%) = 2.5
Level 29.8 mmol/L: SD = 0.5, CV(%) = 1.8	Level 15.7 mmol/L: SD = 0.8, CV(%) = 5.3
Level 25.2 mmol/L: SD = 1.0, CV(%) = 3.9
Level 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(%) = 6.1
Level 25.2 mmol/L: SD = 1.2, CV(%) = 4.9
Level 34.3 mmol/L: SD = 1.6, CV(%) = 4.7
Method Comparison (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 = 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
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.

Ask a Question

Ask a specific question about this device

Page 1 of 1