(25 days)
The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea Nitrogen, Urea, Glucose Creatinine, Calcium, Carbon Dioxide, and Phosphorus.
CREm reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.
The SYNCHRON LX20 System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CREm reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON LX20 System utilizes a two level calibrator for the creatinine test. Beckman Coulter AQUA Cal is designed for optimal performance on the SYNCHRON LX20 Clinical and UniCel DxC Svstems. AQUA Cal 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.
The provided text is a 510(k) Summary for a modification to the SYNCHRON® LX20 Clinical System, specifically concerning the creatinine measurement. It describes the device, its intended use, and a comparison to a predicate device, focusing on the change to calibrator set points.
However, the summary does not contain acceptance criteria or detailed study data proving the device meets acceptance criteria. It states "Performance data from validation testing supports equivalency" but does not elaborate on what that data is, what the acceptance criteria were, or the specifics of the study design.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Not explicitly stated in the provided text, beyond "Performance data from validation testing supports equivalency."
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: Not specified. The document mentions "a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)", but the size of this set is not provided.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the ground truth was established by Isotope Dilution Mass Spectrometry (IDMS), a reference method, not by expert consensus. Even if experts were involved in the IDMS process, their number and qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth was established by IDMS, not human 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 an in vitro diagnostic (IVD) system for quantitative determination of creatinine, not an imaging device or an AI application with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance of the SYNCHRON® LX20 Clinical System is inherently standalone, as it's an automated analyzer. The "modification to the creatinine module (CREm) involves modification of the calibrator set points coded in the chemistry database." The performance evaluation would be of the instrument's accuracy and precision against the IDMS reference method. However, the details of this standalone performance data are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Ground Truth Type: Isotope Dilution Mass Spectrometry (IDMS). This is a highly accurate and precise analytical technique often used as a reference method for determining the true concentration of substances in biological samples.
8. The sample size for the training set:
- Not applicable. This device is a modification of an existing IVD system, and the change is to calibrator set points based on a "one time correlation" to IDMS. It's not a machine learning model that typically has a distinct training set. If 'training' refers to the set used to establish the new calibrator set points, its size is not provided.
9. How the ground truth for the training set was established:
- The new calibrator set points were "value assigned... to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)." This indicates IDMS was used to establish the "ground truth" (reference values) for the samples that informed the new calibrator set points.
§ 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.