(25 days)
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.
CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX® Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.
The SYNCHRON CX Delta System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CRE3 reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON CX Delta System utilizes a two level calibrator for the creatinine test. SYNCHRON CX Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.
Here's an analysis of the provided text regarding the SYNCHRON CX Delta Clinical System, focusing on acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) summary for a modification to an already legally marketed device (SYNCHRON CX Delta Clinical System, K950958). The modification specifically involves changing the calibrator set points for the creatinine module (CRE3) based on correlation to Isotope Dilution Mass Spectrometry (IDMS). This is not an initial clearance of a novel device, so the depth of performance data might differ from a completely new product.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria values (e.g., precision limits, bias limits, linearity ranges) in the provided sections. It broadly states that "Performance data from validation testing supports equivalency."
However, based on the context of a 510(k) for a calibrator set point change, the implicit acceptance criteria would be that the modified system's performance (specifically for creatinine measurement) remains substantially equivalent to the predicate device and meets established analytical performance standards for creatinine assays. These standards would typically involve accuracy, precision, linearity, and verification of the new calibration's impact.
While specific numbers are missing, the type of performance data implied by a calibrator change would include:
| Acceptance Criteria Type (Implicit) | Reported Device Performance (Implied) |
|---|---|
| Accuracy/Bias (vs. IDMS) | Calibrator set points correlated to IDMS. |
| Equivalency to Predicate | "Performance data from validation testing supports equivalency." |
| Precision | (Not explicitly stated, but assumed to be maintained) |
| Linearity | (Not explicitly stated, but assumed to be maintained) |
| Interference | (Not explicitly stated, but assumed to be maintained) |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometry (IDMS)." It does not specify the sample size of this "sample set."
- Data Provenance: Not specified.
- Retrospective or Prospective: The "one-time correlation" suggests a retrospective analysis of an existing sample set, or a prospective collection specifically for this correlation study. The text does not definitively state.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable in the traditional sense of human readers. The "ground truth" for the new calibrator set points was established by Isotope Dilution Mass Spectrometry (IDMS). IDMS is a highly accurate and precise analytical method often used as a reference method for clinical chemistry analytes.
- Qualifications of Experts: N/A for human experts for ground truth establishment. The expertise lies in the IDMS methodology and instrument operators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. IDMS provides a direct, highly accurate measurement; there's no "adjudication" among multiple interpretations.
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 an in vitro diagnostic (IVD) for quantitative measurement of creatinine, not an imaging or AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the core of the evaluation involves the analytical performance of the SYNCHRON CX Delta Clinical System in measuring creatinine, with the new calibrator set points. This is inherently a "standalone" analytical performance assessment, as the device provides a quantitative result directly. The modification (calibrator set points) is applied to the algorithm/instrument's interpretation of the optical density readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Isotope Dilution Mass Spectrometry (IDMS) for the creatinine values used to establish the new calibrator set points. It's a gold standard reference method for creatinine determination.
8. The sample size for the training set
- Not explicitly mentioned. The modification involved "value assignment of the creatinine levels to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometery (IDMS)." This "sample set" serves as the reference for setting the new calibration but the text doesn't differentiate it as a "training set" in the machine learning sense, nor does it specify the size.
9. How the ground truth for the training set was established
- The ground truth for the "sample set" (which functions as the reference for the new calibration and thus, implicitly, a form of "training") was established by Isotope Dilution Mass Spectrometry (IDMS) measurements.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.