(49 days)
The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.
The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.
The provided text is a 510(k) Summary for the Bayer Healthcare CO2 Calibrator/Diluent, which is a diagnostic device used to calibrate CO2 measurements. The nature of this device means that the "acceptance criteria" and "study" described are focused on its performance as a calibrator, primarily its stability and similarity to a predicate device, rather than a clinical study evaluating diagnostic accuracy in patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" or a direct study comparing the device against such criteria in the way one might expect for a diagnostic or imaging algorithm. Instead, it focuses on demonstrating that the device's performance is "similar to other products in commercial distribution intended for similar use" and that its stability meets Bayer's internal procedures.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Stability of CO2 Calibrator/Diluent value | Validated according to Bayer procedures based on results of three separate lots. Stable at 2-8°C until expiration date. Stable for 2 days when opened, reconstituted, stoppered, protected from light, and stored at 2-8°C (similar to predicate's 30-day post-reconstitution stability, but for a different format). |
| Performance vs. Predicate Device | "The performance of the calibrator is similar to other products in commercial distribution intended for similar use." (Comparison to Roche Diagnostics Corp. Calibrator for automated systems, K990460). |
| Intended Use | Meets the specified intended use: "to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments." |
| Format | Aqueous liquid solution containing bicarbonate at a defined concentration (differs from predicate's lyophilized pooled human serum). |
| Level | Single level (matches predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The stability validation was based on "three separate lots of calibrator material." This refers to manufacturing lots, not patient samples or a traditional 'test set' for diagnostic accuracy.
- Data Provenance: The data comes from internal validation procedures conducted by Bayer Healthcare Diagnostics Division. No mention of geographical origin (country) or retrospective/prospective nature other than it being an internal validation of product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of device (a calibrator) does not involve expert interpretation or ground truth establishment in the manner of diagnostic image analysis or clinical data. Its "truth" is its certified concentration and stability, which would be determined through analytical chemistry methods and quality control, not expert consensus.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling differences in expert opinions, which is not applicable to a calibrator device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating human reader performance with medical images or clinical data, often with and without AI assistance. This calibrator device does not involve human readers interpreting clinical cases, nor does it involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This device is a chemical calibrator, not an algorithm. Its performance is inherent to its chemical composition and manufacturing quality.
7. The Type of Ground Truth Used
The "ground truth" for this device would be the analytically verified concentration of bicarbonate and its stability over time and under specified conditions. This is established through accredited laboratory methods and quality control, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
N/A. This device is a calibrator, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this question is not applicable.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.