(23 days)
For in vitro diagnostic use only. VITROS Chemistry Products CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma on the DT60/DT60 II analyzer. 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.
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
The VITROS CRSC assay is performed using the VITROS Chemistry Products CRSC DT Slides and the VITROS Chemistry Products DT Calibrator Kit on VITROS DT60/DT60II Chemistry Systems.
The VITROS CRSC Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glvcine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product.
Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting rate of change in reflection density is proportional to the concentration of creatinine in the sample.
Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be determined using the softwareresident rate math model and the change in reflectance calculated for each unknown test slide.
VITROS DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which inorganic salts have been added. Once reconstituted, the appropriate standards are used to calibrate VITROS DT60/DT60 II Chemistry Systems for the quantitative measurement of creatinine in serum and plasma.
Calibration of the VITROS CRSC assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.
The provided document is a 510(k) summary for the VITROS Chemistry Products CRSC DT Slides and VITROS Chemistry Products DT Calibrator Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance data in the format of a clinical trial for a standalone diagnostic device.
Therefore, much of the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" cannot be found in this document.
The document details the technical characteristics and intended use of the modified device and compares them to the predicate device to establish substantial equivalence. It does not present a de novo clinical study with specific performance metrics and acceptance thresholds.
However, based on the information available, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with direct performance results for the modified device. Instead, it argues for "substantial equivalence" to a predicate device. The performance is assessed by demonstrating consistency in intended use, calibration traceability, and similar principles of operation.
| Device Characteristic | Predicate Device (Original VITROS CRSC assay - K875191) | Modified Device (VITROS CRSC assay) |
|---|---|---|
| Intended Use | For in vitro diagnostic use only. VITROS CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma. For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. | No change from predicate. For in vitro diagnostic use only. VITROS CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma. For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. |
| Calibration traceability | Traceable to Certified NIST (National Institute of Standards and Technology) Reference Material SRM® (Standard Reference Material) 914a. | The values assigned to the VITROS Chemistry Products DT Calibrator Kit for Creatinine are traceable to a Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method¹ and NIST SRM®914, creatinine standard reference material. |
| Reference Interval (Serum) | Males: 0.8 – 1.5 mg/dL; Females: 0.7 – 1.2 mg/dL | Males: 0.7 – 1.3 mg/dL; Females: 0.6 – 1.0 mg/dL |
| Reportable range (Serum) | 0.1 – 16.5 mg/dL | 0.2-11.2 mg/dL |
| Sample type | Serum and Plasma | No change from predicate. Serum and Plasma. |
| Basic principle | Colorimetric rate | No change from predicate. Colorimetric rate. |
| Instrumentation | VITROS DTSC/DTSCII Module | No change from predicate. VITROS DTSC/DTSCII Module. |
The conclusion states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples, and human serum samples with measured creatinine values spanning the assay range." This implies that the performance of the modified device, when evaluated against these samples, was found to be consistent with or equivalent to the predicate device. However, specific numerical acceptance criteria (e.g., % agreement, bias limits) are not provided.
2. Sample sized used for the test set and the data provenance:
- Sample size: The document mentions "human serum samples with measured creatinine values spanning the assay range," but it does not specify the exact number of samples used for the test set.
- Data provenance: Not explicitly stated, but it would typically be from laboratory testing using the device. No country of origin or retrospective/prospective nature is specified, but regulatory submissions like this generally involve prospective data collection for equivalence studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is an in vitro diagnostic assay, and "ground truth" for creatinine measurement is typically established through reference methods or clinical laboratory assays, not expert consensus in the way image analysis or clinical diagnosis might be. The document refers to "measured creatinine values" but doesn't detail how these were established beyond mentioning traceability to NIST SRM®914a and GC/IDMS.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of IVD device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
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 is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device (VITROS CRSC assay with VITROS Chemistry Products CRSC DT Slides) is an automated system for measuring creatinine. Its performance is inherently "standalone" in the sense that the measurement is performed by the instrument and reagents, not by human interpretation of raw data. The study mentioned to demonstrate equivalence would thus evaluate its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for creatinine measurement in the equivalence study would be established by reference methods or highly accurate laboratory measurements, as indicated by the mention of traceability to NIST SRM®914a and a Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method. These are highly precise and accurate analytical techniques considered gold standards for creatinine measurement.
8. The sample size for the training set:
Not applicable. This is a chemical assay, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no "training set."
§ 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.