FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Device Description

GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the GenChem Calcium, Azo Dye Reagent, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Precision	Low %CV (Coefficient of Variation) for both within-run and total imprecision, indicating consistent and reproducible results across various calcium levels. Specific targets are not explicitly stated but are implicit in good laboratory practice and NCCLS standards.	Serum 1 (7.2 mg/dL): Within-run SD 0.06, %CV 0.7; Total SD 0.10, %CV 1.4
Serum 2 (10.6 mg/dL): Within-run SD 0.05, %CV 0.5; Total SD 0.09, %CV 0.9
Serum 3 (14.0 mg/dL): Within-run SD 0.05, %CV 0.3; Total SD 0.09, %CV 0.6
Urine 1 (4.0 mg/dL): Within-run SD 0.03, %CV 0.7; Total SD 0.16, %CV 4.1
Urine 2 (12.7 mg/dL): Within-run SD 0.06, %CV 0.5; Total SD 0.13, %CV 1.0
Linearity	Strong linear relationship (R-squared close to 1.0) across the claimed analytical range, with a slope close to 1 and intercept close to 0 when compared to reference or known values.	Slope: 0.911
Intercept: 0.34
Standard error of estimate: 0.35
R-squared (r²): 1.000 (indicating excellent linearity)
Reportable Range	Defined usable range for accurate measurements.	Conventional Units: 0.1 to 15 mg/dL
SI Units: 0.5 – 3.75 mmol/L
Sensitivity	Ability to detect the lowest concentration of calcium accurately. The observed sensitivity should be at or below the claimed limit.	Claimed sensitivity: 0.1 mg/dL
Observed sensitivity (3 SD of 21 replicate within-run precision study): 0.05 mg/dL (which is below the claimed limit)
Analytical Specificity	No significant interference from common endogenous substances (hemoglobin, bilirubin, lipemia) or acceptable anticoagulants.	Hemoglobin: Up to 500 mg/dL showed no adverse effect.
Bilirubin: Up to 20 mg/dL showed no adverse effect.
Lipemia: Up to 1800 mg/dL showed no adverse effect.
Acceptable Anticoagulants: Heparin, Lithium Heparin, Ammonium Heparin, EDTA.
Method Comparison	Good correlation with a legally marketed predicate device (Predicate Device Name: HICHEM Calcium Reagent for the CX3). Indicators include R-squared close to 1.0, slope close to 1, and intercept close to 0.	Serum: Intercept -0.1, Slope 0.994, R² 0.971
Plasma: Intercept -0.1, Slope 0.973, R² 0.980
Urine: Intercept 0.1, Slope 0.999, R² 0.999
Expected Values	Provision of reference ranges for serum/plasma and urine.	Serum/Plasma: 8.4 - 10.2 mg/dL (2.10 - 2.55 mmol/L)
Urine: 100 - 300 mg/day (2.5 - 7.5 mmol/day)
(Note: Stated that "Each laboratory should establish its own normal ranges.")

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision:
  - 60 data points for each of 5 samples (3 serum controls, 2 urine pools). Total 300 measurements.
  - Data provenance: Not explicitly stated, but implies laboratory-prepared control sera and diluted urine pools, likely internal to GenChem or the testing facility.
- Linearity:
  - Commercially available linearity standards (0 to 15 mg/dL) analyzed in triplicate. Specific number of standards not given, but at least 2 points are needed to determine a slope.
  - Data provenance: Commercially available standards.
- Sensitivity:
  - 21 replicates of a diluted serum control.
  - Data provenance: Diluted serum control.
- Analytical Specificity:
  - Hemoglobin, Bilirubin, Lipemia (stock solutions tested with a base pool containing 9.4 mg/dL calcium). Number of samples not specified, but typically involves a few replicates for each interferent.
  - Data provenance: Prepared stock solutions and a base pool.
- Patient Comparison (Method Comparison):
  - Serum: N = 82 patient specimens
  - Plasma: N = 84 patient specimens
  - Urine: N = 76 patient specimens
  - Data provenance: "collected from adult patients." Country of origin is not specified, but the context implies it was likely from a clinical site in the US. The data is retrospective, as the samples were "collected" and then assayed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Precision, Linearity, Sensitivity, Analytical Specificity: Not applicable. The "ground truth" for these tests comes from known concentrations in control materials or the inherent chemical properties of analytes and interferents.
- For Method Comparison: The ground truth is established by the results obtained from the predicate device (HICHEM Calcium Reagent for the CX3) on the Beckman CX3 Synchron Analyzer. There is no mention of human experts establishing ground truth for these quantitative measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a quantitative diagnostic device, not one requiring subjective interpretation that would necessitate adjudication among human readers. The performance is assessed by comparing numerical results to expected values or a predicate device.
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:
- No. This is a chemical reagent for an automated analyzer, not an AI-assisted diagnostic imaging or interpretative device. Therefore, MRMC studies and human reader improvement with AI are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The entire performance evaluation describes the standalone performance of the GenChem Calcium Reagent on the Beckman CX3® System. The test results are generated by the algorithm (reagent and instrument's measurement process) without human interpretive input affecting the quantitative result itself (though human interaction is needed for sample loading, running the test, and interpreting the final numerical value in a clinical context).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Precision, Linearity, Sensitivity, Analytical Specificity: Known concentrations of control materials, linearity standards, or stock solutions.
- Method Comparison: Results from a legally marketed predicate device (HICHEM Calcium Reagent for the CX3), assuming the predicate device provides accurate measurements, served as the reference for comparison.
The sample size for the training set:
- Not applicable. This device is a chemical reagent and not an AI/machine learning algorithm that requires a training set in the conventional sense. The development of such reagents relies on chemical formulation, optimization, and validation studies rather than data-driven "training."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.