(242 days)
Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode.
Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.
Diamond Diagnostics ISE Serum Standards and ISE Urine Standards are intended to serve as a direct replacement to Siemens (Bayer) Advia ISE Serum Standards and ISE Urine Standards.
Diamond Diagnostics ISE Serum Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products It is a liquid packaged in a 100mL high density polyethylene (HDPE) dropper bottle. It consists of one Serum Low Standard and one Serum High Standard sold as a set in a box.
Diamond ISE Urine Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products. It is a liquid packaged in a 100mL HDPE dropper bottle. It consists of one Urine Low Standard and one Urine High Standard sold as a set in a box.
This document describes the Diamond Diagnostics ISE Serum Standards and ISE Urine Standards, which are calibrators for medical devices. The document highlights the product's characteristics, intended use, and a comparison with a predicate device to demonstrate substantial equivalence.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the target values for each analyte in the standards, with a defined tolerance range. The "reported device performance" refers to the target values that the manufactured calibrators are designed to meet and are verified against.
Diamond Diagnostics ISE Serum Standard Low:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 130 ± 2 | 130 ± 2 |
| K+ | mmol/L | 3.5 ± 0.05 | 3.5 ± 0.05 |
| Cl- | mmol/L | 85 ± 2 | 85 ± 2 |
Diamond Diagnostics ISE Serum Standard High:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 160 ± 2 | 160 ± 2 |
| K+ | mmol/L | 6 ± 0.05 | 6 ± 0.05 |
| Cl- | mmol/L | 120 ± 2 | 120 ± 2 |
Diamond Diagnostics ISE Urine Standard Low:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 50 ± 2 | 50 ± 2 |
| K+ | mmol/L | 10 ± 0.2 | 10 ± 0.2 |
| Cl- | mmol/L | 50 ± 2 | 50 ± 2 |
Diamond Diagnostics ISE Urine Standard High:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 200 ± 3 | 200 ± 3 |
| K+ | mmol/L | 100 ± 2 | 100 ± 2 |
| Cl- | mmol/L | 180 ± 2 | 180 ± 2 |
The study demonstrates that the manufactured standards are tested to assure they meet these target values within the predetermined acceptance criteria.
2. Sample size used for the test set and the data provenance
- Test Set Description: The document refers to testing "reagents analytically prior to bottling" and "analytically during the bottling process and prior to release to stock for distribution." Additionally, "Six replicates of each sample are tested analytically for the electrolytes."
- Sample Size: Six replicates of each standard (ISE Serum Standard Low, ISE Serum Standard High, ISE Urine Standard Low, ISE Urine Standard High) were tested.
- Data Provenance: The data appears to be prospective, generated during the manufacturing and quality control process of the Diamond Diagnostics ISE Standards. The country of origin is not explicitly stated but implied to be the US given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is a calibrator, and its performance is evaluated against chemical reference standards and methods, not expert human interpretation.
4. Adjudication method for the test set
This section is not applicable. The evaluation relies on objective analytical measurements rather than subjective human assessment requiring 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
This section is not applicable. The device is a chemical calibrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a chemical calibrator. However, the performance of the calibrator itself is assessed in a "standalone" manner through analytical testing of its constituent analytes using specified reference methods.
7. The type of ground truth used
The ground truth for the test set is established by:
- Reference Standard Materials: NIST (National Institute of Standards and Technology) salts (NIST 919b for Na and Cl, NIST 918b for K) which are gravimetrically prepared.
- Reference Methods:
- IL 943 Flame Photometry for Na+ and K+.
- SAT-500 Salt Analyzer (Titrimetric method) for Cl-.
8. The sample size for the training set
This section is not applicable. The device is a calibrator, and its formulation and target values are based on established chemical principles and comparison to predicate devices, not a 'training set' in the machine learning sense. The "training" for such a device would be the formulation and manufacturing process designed to consistently achieve the specified concentrations.
9. How the ground truth for the training set was established
This section is not applicable. As explained in point 8, there isn't a "training set" in the traditional sense for this type of device. The "ground truth" for the calibrator's target values is established by:
- Gravimetric Preparation from NIST Standards: Analytes are derived from NIST certified reference materials.
- Analytical Verification using Reference Methods: The final concentrations are verified using established and accurate analytical methods (Flame Photometry and Titrimetry).
- Matching Predicate Device Values: The target values were chosen to match those of the predicate ADVIA ISE Serum Standards and ISE Urine Standards.
§ 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.