(50 days)
Used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.
CO2 Acid Reagent, Procedure Number C7558
This document is a 510(k) Notification for a diagnostic medical device, specifically the Sigma Diagnostics CX®3 CO2 Acid Reagent. It is not based on AI/ML; it's a traditional chemical reagent for measuring carbon dioxide. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable to this type of device and study.
However, I can extract the information relevant to its performance and acceptance criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalency to predicate device | Correlation coefficient: 0.992 |
| Regression equation: y = 0.95x + 1.54 | |
| Within-run precision (Implied %CV target) | %CV < 6.5% |
| Total precision (Implied %CV target) | %CV < 6.5% |
| Linearity (Implied acceptable range) | Linear from 5.0 to 40.0 mmol/L |
| Identical reaction principles | Reaction principles are identical to predicate device |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The text mentions "serum samples" were used in comparison studies, but the exact number is not provided.
- Data provenance: "Serum samples." The country of origin is not specified, but the submission is to the FDA in the US. The study is retrospective in the sense that existing serum samples would have been used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a chemical reagent. "Ground truth" would be established by the reference method or the predicate device's accepted performance, not by expert interpretation.
4. Adjudication method for the test set
- Not applicable. This is a chemical reagent. Data comparison would involve statistical analysis against the predicate device, not expert adjudication.
5. 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 not AI-based, nor does it involve human readers interpreting images or data in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a chemical reagent, not an algorithm. Its performance is inherent in its chemical reaction.
7. The type of ground truth used
- The "ground truth" or reference for comparison was the Beckman CO2 Acid Reagent Kit, Part No. 443330. The study aimed to demonstrate substantial equivalence to this predicate device rather than an absolute biological truth established by, for example, pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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OCT 2 4 1996
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 CO, Acid Reagent Procedure Number C7558 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Carbon dioxide (CO-) in serum or plasma exists primarily as dissolved CO2 and bicarbonate anion (HCO2).1 The CO2 content is decreased in metabolic acidosis and respiratory alkalosis, whereas the level is increased in metabolic alkalosis and respiratory acidosis.2 In pathologic conditions such as in diabetes mellitus, glomerulonephritis, pyloric obstruction, or diarrhea, acidosis or alkalosis can be anticipated.3 Therefore, determination of plasma CO2 content as part of an electrolyte profile helps establish whether, and to what degree, the anticipated change has occurred in the above patients.
The safety and effectiveness of Sigma Diagnostics CO2 Acid Reagent, Procedure Number C7558, are demonstrated by its substantial equivalency to Beckman CO2 Acid Reagent Kit, Part No. 443330. Both CO2 acid reagents are used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System, and the reaction principles for both are identical. In comparison studies, a correlation coefficient of 0.992 and a regression equation of y = 0.95x + 1.54 was obtained with serum samples. With-in run precision and total precision on serum samples demonstrated %CV's of less than 6.5 %. The Sigma Diagnostics CO2 Alkaline Buffer has been determined to be linear from 5.0 to 40.0 mmol/L on the SYNCHRON CX®3 System.
REFERENCES
- Clinical Chemistry, LA Kaplan, AJ Pesce, Editors, CV Mosby Company, St. Louis (MO) 1. 1989
- Hydrogen Ion Concentration in Body Fluids. IN Contarow and Trumper Clinical 2. Biochemistry, 7 th ed., AL Latner, Editor, Saunders, Philadelphia, 1975, p 399
- Tietz, NW, Prudent EL, Siggaard-Anderson O: Electrolytes, Blood Gases, and Acid-Base 3. Balance. IN Textbook of Clinical Chemistry, NW Tietz, Editor, Saunders, Philadelphia, 1986, p 1188
§ 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.