(121 days)
Not Found
No
The device description details a standard immunoassay technique with magnetic separation and spectrophotometric detection. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section of the summary.
No
This device is an in vitro diagnostic test designed to measure Sirolimus levels in human whole blood, aiding in the management of sirolimus therapy. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood..." and "The Sirolimus Calibrator is an in vitro diagnostic product...".
No
The device description clearly outlines a hardware-based in vitro diagnostic system (Dimension® clinical chemistry system) that uses physical reagents, magnetic particles, and optical measurements to perform the assay. While software is undoubtedly involved in controlling the system and processing data, the core functionality and components are hardware-based.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The text explicitly states "The SIRO method is an in vitro diagnostic test..." and "The Sirolimus Calibrator is an in vitro diagnostic product...".
- Device Description: The description details a laboratory test performed on a human whole blood sample using reagents and a clinical chemistry system. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The inclusion of method comparison and reproducibility studies, common for IVD devices to demonstrate performance characteristics.
- Predicate Device: The mention of a predicate device (K042411 Abbott IMx Sirolimus Microparticle Enzyme Immunoassay and IMx Sirolimus Calibrator) which is also an IVD, further supports the classification of this device as an IVD.
Therefore, all the provided information points to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of Sirolimus are used as an aid in the management of sirolimus therapy in renal transplant patients.
The Sirolimus Calibrator is an in vitro diagnostic product for the calibration of Sirolimus (SIRO) on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
NRP, DLJ
Device Description
The automated Dimension® SIRO method uses an immunoassay technique in which free and sirolimus-bound antibody-enzyme conjugates are separated using magnetic particles. The assay is performed using a method specific Flex® reagent cartridge. The Flex® cartridge contains a pretreatment reagent, antibody-B-galactosidase conjugate, sirolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets.
To perform the SIRO assay, a sample cup (or SSC) containing the whole blood sample to be analyzed and a SIRO Flex® reagent cartridge are placed appropriately on the Dimension® system. The Dimension® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody enzyme conjugate. The sirolimus present in the sample is bound by the sirolimus antibody conjugate reagent. Magnetic particles coated with sirolimus are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the sirolimus-antibody-enzyme complex is transferred to another cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d-galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of sirolimus in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.
The Dimension® Sirolimus Calibrator (DC306) is an in-vitro diagnostic product intended to be used to calibrate the Dimension® Sirolimus method. It is a frozon liquid product packaged as a single vial for each of five levels. The matrix is human whole blood hemolysate with preservatives. Levels 2, 3, 4, and 5 contain sirolimus drug at target values of 5, 10, 20, and 31.5 ng/mL, respectively. Level 1 is a human whole blood hemolysate that does not contain sirolimus drug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison: A split patient sample (EDTA whole blood) method comparison demonstrated good agreement between the Siemens Dimension® SIRO method and HPLC/MS, the reference method.
Results:
HPLC/MS Sample Range: 2.8 - 23.7 ng/mL
Dimension® Sample Range: 2.4 - 25.6 ng/mL
n: 119
Slope: 1.2
Intercept: -0.7 ng/mL
Correlation Coefficient: 0.95
The model equation for the Linear regression statistics is: [results for Dimension® Siro] = slope x [comparative method results] + intercept.
Reproducibility: Typical precision observed for the Dimension SIRO method is summarized below:
Sample: Level 1 Whole Blood Pool, Mean (ng/mL): 4.41, Repeatability SD (ng/mL): 0.35, %CV: 8.0, Within Lab SD (ng/mL): 0.38, %CV: 8.61
Sample: Level 2 Whole Blood Pool, Mean (ng/mL): 12.55, Repeatability SD (ng/mL): 0.72, %CV: 5.73, Within Lab SD (ng/mL): 0.72, %CV: 5.77
Sample: Level 3 Whole Blood Pool, Mean (ng/mL): 25.35, Repeatability SD (ng/mL): 1.69, %CV: 6.67, Within Lab SD (ng/mL): 1.79, %CV: 7.07
Sample: Level 1 QC, Mean (ng/mL): 2.7, Repeatability SD (ng/mL): 0.35, %CV: 12.98, Within Lab SD (ng/mL): 0.39, %CV: 14.52
Sample: Level 2 QC, Mean (ng/mL): 10.58, Repeatability SD (ng/mL): 0.58, %CV: 5.48, Within Lab SD (ng/mL): 0.61, %CV: 5.75
The reproducibility testing was conducted in accordance with the CLSI Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day. Testing was conducted with one reagent lot across multiple instruments at one internal and two external locations. The repeatability and within-lab standard deviations were calculated by the analysis of variance method independently for each site. The data above is representative of the results obtained in the reproducibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reportable Range: 1.5 to 30 ng/mL
Functional Sensitivity:
§ 862.3840 Sirolimus test system.
(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
0
510k Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | George M. Plummer
Siemens Healthcare Diagnostics
P.O. Box 6101
Newark, DE 19714-6101 | OCT 30 2008 |
|-----------------------------|-------------------------------------------------------------------------------------------------|-------------|
| Date of Preparation: | June 26, 2008 | |
| Name of Product(s): | Dimension SIRO Flex® reagent cartridge | |
| FDA Classification Name(s): | Sirolimus Test System(862.3840)
Clinical Toxicology Calibrator(862.3200) | |
| FDA Guidance Documents: | Class II Special Controls Guidance Document: Sirolimus Test Systems | |
| Predicate Device(s): | Abbott IMx Sirolimus Microparticle Enzyme Immunoassay and IMx
Sirolimus Calibrator (K042411) | |
Device Description(s):
The automated Dimension® SIRO method uses an immunoassay technique in which free and sirolimus-bound antibody-enzyme conjugates are separated using magnetic particles. The assay is performed using a method specific Flex® reagent cartridge. The Flex® cartridge contains a pretreatment reagent, antibody-B-galactosidase conjugate, sirolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets.
To perform the SIRO assay, a sample cup (or SSC) containing the whole blood sample to be analyzed and a SIRO Flex® reagent cartridge are placed appropriately on the Dimension® system. The Dimension® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody enzyme conjugate. The sirolimus present in the sample is bound by the sirolimus antibody conjugate reagent. Magnetic particles coated with sirolimus are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the sirolimus-antibody-enzyme complex is transferred to another cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d-galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of sirolimus in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.
| Sirolimus + Ab-β-gal | → | Sirolimus-Ab-β-gal + Ab-β-gal |
|---|---|---|
| Sirolimus-Ab-β-gal + Ab-β-gal + | ||
| CrO2-Sirolimus | Magnetic separation | Sirolimus-Ab-β-gal |
| (transferred to cuvette) | ||
| CPRG | ||
| (non-absorbing at 577 nm) | CPR | |
| (absorbs at 577 nm) |
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The Dimension® Sirolimus Calibrator (DC306) is an in-vitro diagnostic product intended to be used to calibrate the Dimension® Sirolimus method. It is a frozon liquid product packaged as a single vial for each of five levels. The matrix is human whole blood hemolysate with preservatives. Levels 2, 3, 4, and 5 contain sirolimus drug at target values of 5, 10, 20, and 31.5 ng/mL, respectively. Level 1 is a human whole blood hemolysate that does not contain sirolimus drug.
Intended Use:
SIRO Flex® reagent cartridge
The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of Sirolimus are used as an aid in the management of sirolimus therapy in renal transplant patients.
Sirolimus Calibrator
The Sirolimus calibrator is an in vitro diagnostic product for the calibration of Sirolimus (SIRO) on the Dimension® clinical chemistry system.
Substantial Equivalence:
A summary of the performance attributes of the Siemens SIRO Flex® reagent cartridge/SIRO Calibrator and the predicate Abbott IMx Sirolimus Microparticle Enzyme Immunoassay (K042411)/IMx Sirolimus Calibrator is provided in the following charts.
| Item | Abbott Sirolimus | Dimension® SIRO |
|---|---|---|
| Intended | ||
| Use | The IMx® Sirolimus assay is an in vitro | |
| reagent system for the quantitative | ||
| determination of sirolimus in human | ||
| whole blood, as an aid in the | ||
| management of renal transplant patients | ||
| receiving therapy with sirolimus | The SIRO method is an in vitro diagnostic | |
| test for the quantitative measurement of | ||
| Sirolimus in human whole blood on the | ||
| Dimension® clinical chemistry system. | ||
| Measurements of Sirolimus are used as an | ||
| aid in the management of sirolimus | ||
| therapy in renal transplant patients. | ||
| Assay | ||
| Technology | Enzyme immunoassay (Microparticle) | Enzyme immunoassay (Affinity chrome |
| mediated) | ||
| Sample | ||
| Type | EDTA whole blood | EDTA whole blood |
| Expected | ||
| Values | ||
| (Reference | ||
| Interval) | Not applicable for immunosuppressive | |
| drug assays. Optimal ranges depend | ||
| upon the patient's clinical state, | ||
| individual differences in sensitivity to | ||
| immunosuppressive and nephrotoxic | ||
| effects of sirolimus, co-administration | ||
| of other immunosuppressants, time post | Not applicable for immunosuppressive | |
| drug assays. Optimal ranges depend upon | ||
| the patient's clinical state, individual | ||
| differences in sensitivity to | ||
| immunosuppressive and nephrotoxic | ||
| effects of sirolimus, co-administration of | ||
| other immunosuppressants, time post |
Table of Similarities
2
| transplant and of other factors. | transplant and of other factors. | |
|---|---|---|
| Calibrator | ||
| Matrix | human whole blood containing | |
| sirolimus | human whole blood containing sirolimus |
Table of Differences
| Item | Abbott Sirolimus | Dimension® SIRO |
|---|---|---|
| Sample Pretreatment | Required | Not required |
| Reportable Range | 0 to 30 ng/mL | 1.5 to 30 ng/mL |
| Functional Sensitivity |