(51 days)
Not Found
No
The description details a standard immunoassay method based on chemical reactions and light detection, with results determined via a calibration curve. There is no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic immunoassay used to measure digoxin levels in human samples, which aids in diagnosis and monitoring, but does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "for the in vitro diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy," which indicates its purpose in identifying and evaluating a medical condition.
No
The device description clearly outlines a physical immunoassay process involving chemical reactions, incubation, magnetic capture of microparticles, and measurement of chemiluminescent emission using a photomultiplier. This involves significant hardware components and physical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma for the in vitro diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay process involving the analysis of biological samples (serum and plasma) outside of the body. This is characteristic of an IVD.
- Performance Studies: The inclusion of performance characteristics like precision, lower detection limit, linearity, method comparison, interfering substances, and specificity are standard for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (Abbott TDx® Digoxin II Assay) with a K number (K882233) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for IVDs.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of Digoxin in human serum and plasma.
Immunoassay for the in vitro quantitative determination of digoxin in human serum and minutedssar for the in Are quarthe diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy .
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
Product codes
KXT
Device Description
Competition principle. Total duration of assay: 18 minutes, 37 ℃. · 1st incubation (9 minutes): By incubating the sample (10 µL) with a digoxin-specific ruthenylated** antibody (80 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample. · 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (30 uL) and a digoxin derivative labeled with biotin (80 uL), the still-vacant sites of the ruthenylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
·The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+3)
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
Prescription Use
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)
Performance Characteristics:
Precision: Modified NCCLS (ng/mL):
Level 1, N=60, Within run: 1.34, %CV: 3.57, Total: 1.34, %CV: 5.24
Level 2, N=60, Within run: 3.08, %CV: 3.33, Total: 3.08, %CV: 4.09
Pool 1, N=60, Within run: 0.85, %CV: 5.22, Total: 0.85, %CV: 7.69
Lower Detection Limit: 0.15 ng/mL
Linearity: 0.15 - 5 ng/mL
Method Comparison: Vs Abbott TDx Digoxin
Least Squares: y =1.03X + 0.10, r=0.9847, N=357
Passing Bablock: y=1.06X + 0.06, r=0.9847, N=357
Interfering substances: No interference at: (within 0.15 ng/ml at digoxin level 1.5 ng/ml.)
Bilirubin: 65 mg/dL
Hemoglobin: 1000 mg/dL
Lipemia: 1500 mg/dL
Rheumatoid Factor: 1630 IU/mL
Biotin: 100 ng/ml
Specificity: % Cross-reactivity
Digoxigenin: 14.28
Digoxingenin-Mono-Digitoxiside: 55.31
Digitoxin-Bis-Digitoxiside: 74.64
Digitoxin: 1.13
Cortisol:
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
OCT 1997
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| 1. | |
| Submitter | |
| name, | |
| address, | |
| contact | Boehringer Mannheim Corporation |
| 2400 Bisso Lane | |
| P.O. Box 4117 | |
| Concord, CA 94524-4117 | |
| (510) 674 - 0690, extension 8413 | |
| Fax: (510) 687-1850 | |
| Contact Person: Yvette Lloyd | |
| Date Prepared: August 14, 1997 | |
| 2. | |
| Device name | Proprietary name: Elecsys® Digoxin Assay |
| Common name: Electrochemiluminescent immunoassay for the determination of Digoxin. | |
| Classification name: System, Test, Digoxin | |
| 3. | |
| Predicate | |
| device | The Boehringer Mannheim Elecsys® Digoxin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® Digoxin II Assay (K882233). |
Continued on next page
/
1
Image /page/1/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo is a black square with a white circle in the center. The word "boehringer" is written in white inside the circle. The word "mannheim" is written vertically in white on the left side of the square. The logo is simple and modern.
- Device Description
Competition principle. Total duration of assay: 18 minutes, 37 ℃. · 1st incubation (9 minutes): By incubating the sample (10 µL) with a digoxinspecific ruthenylated** antibody (80 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample. · 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (30 uL) and a digoxin derivative labeled with biotin (80 uL), the still-vacant sites of the ruthenylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
·The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+3)
2
0(k) Summary, Continued
Image /page/2/Picture/1 description: The image shows the logo for Boehringer Mannheim. The logo consists of a black square with a white circle inside. The word "boehringer" is written in white inside the circle. The word "mannheim" is written vertically in white on the left side of the square.
| 5.
Intended use | Immunoassay for the in vitro quantitative determination of Digoxin in human
serum and plasma. |
| -------------------- | -------------------------------------------------------------------------------------------------- |
|---|
- Comparison to predicate device
The Boehringer Mannheim Elecsys® Digoxin Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® Digoxin II Assay (K882233).
The following table compares the Elecsys® Digoxin Assay with the predicate device, Abbott TDx® Digoxin II Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.
Similarities:
·Intended Use: Immunoassay for the in vitro quantitative determination of Digoxin
·Sample type: Serum and plasma
•Assay range: 0 - 5 ng/mL
3
BOEHRINGENO(k) Summary, Continued MANNHEIM CORPORATION
Image /page/3/Picture/1 description: The image shows a logo with the text "mannheim" vertically aligned on the left side. To the right of this text is a black square containing a white circle. Inside the circle is the text "boehringer" in a stylized font. The logo appears to be for a company named Boehringer Mannheim.
- Comparison
to predicate device cont.
Differences:
| Feature | Elecsys®
Digoxin | TDx
Digoxin II |
|----------------------------|--------------------------|---------------------------|
| Reaction test
principle | Electrochemiluminescence | Fluorescence Polarization |
| Instrument
required | Elecsys® 2010 | Abbott TDx |
Performance Characteristics:
| Feature | Elecsys®
Digoxin | | | TDx
Digoxin II | | |
|------------|-------------------------|---------|--------|-------------------|------|------|
| Precision | Modified NCCLS (ng/mL): | | | NCCLS (ng/mL): | | |
| Level | Level 1 | Level 2 | Pool 1 | Low | Mid | High |
| N | 60 | 60 | 60 | 50 | 50 | 50 |
| Within run | 1.34 | 3.08 | 0.85 | 0.70 | 1.44 | 3.66 |
| %CV | 3.57 | 3.33 | 5.22 | 5.75 | 3.15 | 1.87 |
| Total | 1.34 | 3.08 | 0.85 | 0.70 | 1.44 | 3.66 |
| %CV | 5.24 | 4.09 | 7.69 | 7.67 | 3.98 | 1.91 |
4
BOEHRINGEA 0(k) Summary, Continued MANNHEIM CORPORATION
Image /page/4/Picture/1 description: The image shows a logo with the word "boehringer" inside of a circle. To the left of the circle is the word "mannheim" written vertically. The logo is black and white and has a horizontal line underneath it.
- Comparison to predicate device, (cont.)
·
Performance Characteristics:
| Feature | Elecsys®
Digoxin | TDx
Digoxin II |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Lower
Detection
Limit | 0.15 ng/mL | 0.2 ng/mL |
| Linearity | 0.15 - 5 ng/mL | 0.0 - 5.0 ng/mL |
| Method
Comparison | Vs Abbott TDx
Digoxin | Vs Baxter Dade Stratus |
| | Least Squares:
$y =1.03X + 0.10$
r=0.9847
N=357 | $y =0.94x + 0.08$
r=0.962
N=200 |
| | Passing Bablock:
$y=1.06X + 0.06$
r=0.9847
N=357 | |
| Feature | Elecsys®
Digoxin | TDx
Digoxin II |
| Interfering substances | No interference at:
(within 0.15 ng/ml at
digoxin level 1.5 ng/ml.) | No interference at: |
| Bilirubin | | |
| Hemoglobin | 65 mg/dL | 20 mg/dL |
| Lipemia | 1000 mg/dL | 1000 mg/dL |
| Rheumatoid Factor | 1500 mg/dL | 2500 mg/dL |
| Biotin | 1630 IU/mL | N/A |
| | 100 ng/ml | N/A |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| Digoxigenin | 14.28 | up to 200 |
| Digoxingenin-Mono-
Digitoxiside | 55.31 | up to 200 |
| Digitoxin-Bis-
Digitoxiside | 74.64 | up to 200 |
| Digitoxin | 1.13 | 4.8 |
| Cortisol |