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510(k) Data Aggregation
(216 days)
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
For the quantitative measurement of OC 125 defined antigen concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System. The VITROS CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The VITROS Immunodiagnostic Products CA 125 II Reagent Pack (test) is performed using the VITROS CA 125 II Reagent Pack and VITROS CA 125 II Calibrators on the VITROS 5600 System. An immunometric immunoassay technique is used, which involves the reaction of OC 125 present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-OC 125) bound to Streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (Mouse monoclonal anti- OC 125). Unbound (HRP)-labeled anti-OC 125 antibody conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of conjugate bound is directly proportional to the concentration of OC 125 present in the sample.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the VITROS Immunodiagnostic Products CA 125 II Reagent Pack:
This document is a 510(k) summary for a medical device ([K221355](https://510k.innolitics.com/search/K221355)) and primarily focuses on demonstrating substantial equivalence to a predicate device. As such, it reports on various analytical performance studies rather than user studies or comparative effectiveness studies involving human readers or AI.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Precision | % CV for various CA 125 concentrations (implied to be within acceptable clinical limits) | For Sample 1 (9.09 U/mL): Total SD=0.21, %CV=2.4 |
| For Sample 2 (29.5 U/mL): Total SD=0.55, %CV=1.9 | ||
| For Sample 3 (105 U/mL): Total SD=2.04, %CV=1.9 | ||
| For Sample 4 (268 U/mL): Total SD=4.70, %CV=1.8 | ||
| For Sample 5 (401 U/mL): Total SD=7.35, %CV=1.8 | ||
| For Sample 6 (767 U/mL): Total SD=11.74, %CV=1.5 | ||
| Detection Capability | Limit of Detection (LoD) $\ge$ 5.5 U/mL, Limit of Quantitation (LoQ) $\le$ 5.5 U/mL at 20% CV (designed) | LoD: 5.5 U/mL |
| LoQ (observed): 0.8 U/mL at 20% CV | ||
| Claimed LoQ: 5.5 U/mL | ||
| Linearity | Linear over the measuring range (e.g., 80.0% to 101% recovery, R$^2$ close to 1) | Linearity Range: 3.6 to 1288 U/mL |
| % Recovery: 80.0% to 101% | ||
| Slope: 0.992 (95% CI: 0.985 to 0.999) | ||
| Intercept: -0.932 (95% CI: -1.075 to -0.788) | ||
| R$^2$: 1.000 | ||
| Matrix Comparison | Serum and plasma (Li-Hep, EDTA) deemed equivalent (implied by "Pass" status based on Deming regression results) | Li-Hep vs. Serum: Slope=0.984, Intercept=0.160, Correlation=1.000 (Pass) |
| EDTA vs. Serum: Slope=0.990, Intercept=0.162, Correlation=1.000 (Pass) | ||
| Analytical Specificity (Interference) | Observed bias $\ge$ 10% for specific interferents should be identified. Substances not interfering should have bias $ 35 U/mL) for Lot 9991 on VITROS 5600. (1/60 = 1.67% |
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