(65 days)
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No
The summary describes a standard immunoassay with performance characteristics evaluated using traditional statistical methods. There is no mention of AI, ML, image processing, or any data analysis techniques indicative of AI/ML.
No
This device is an immunoassay for the quantitative determination of Digoxin, which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is an immunoassay for the quantitative determination of Digoxin in serum and plasma, which is a diagnostic act used to measure the levels of a substance in the body for the purpose of diagnosis or monitoring.
No
The device description clearly indicates it is a "Homogeneous enzyme immunoassay," which is a laboratory-based test involving chemical reagents and physical processes, not solely software. The performance studies also describe laboratory-based testing methods and metrics.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of Digoman serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description mentions a "Homogeneous enzyme immunoassay for the determination of Digoxin." Immunoassays are a common type of test performed in vitro to detect or measure substances in biological samples.
- Performance Studies: The description of performance studies details tests performed on samples (serum and plasma) to evaluate the device's performance, which is typical for IVDs.
The information provided clearly indicates that this device is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of Digoman serum and plasma.
Product codes
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Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Precision:
CEDIA Digoxin (Modified NCCLS (ng/mL)):
Level 1: N=120, Within run=1.0, %CV=4.25, Total=1.0, %CV=6.71
Level 2: N=120, Within run=1.7, %CV=3.45, Total=1.7, %CV=4.17
Level 3: N=120, Within run=3.8, %CV=1.45, Total=3.8, %CV=2.01
TDx Digoxin II (NCCLS (ng/mL)):
Low: N=50, Within run=0.70, %CV=5.75, Total=0.70, %CV=7.67
Mid: N=50, Within run=1.44, %CV=3.15, Total=1.44, %CV=3.98
High: N=50, Within run=3.66, %CV=1.87, Total=3.66, %CV=1.91
Lower Detection Limit:
CEDIA Digoxin: 0.15 ng/mL
TDx Digoxin II: 0.2 ng/mL
Linearity:
CEDIA Digoxin: 0.15 - 4 ng/mL
TDx Digoxin II: 0.0 - 4.0 ng/mL
Method Comparison:
CEDIA Digoxin Vs Abbott TDx Digoxin:
Least Squares: y = 0.97x - 0.17, r=0.9667, N=99
Deming's: y = 1.00x - 0.22, r=0.9667, N=99
TDx Digoxin II Vs Baxter Dade Stratus:
y = 0.94x + 0.08, r=0.962, N=200
Interfering substances for CEDIA Digoxin:
Bilirubin at 66 mg/dL, Hemoglobin at 1000 mg/dL, Triglyceride Lipemia at 100 mg/dL, Total Protein at 10 g/dL, and Rheumatoid Factor at 100 IU/mL shown in table to have no interference.
Interfering substances for TDx Digoxin II:
No interference at: 20 mg/dL Bilirubin, 1000 mg/dL Hemoglobin, 2500 mg/dL Triglyceride Lipemia, and other specified substances.
Specificity (% cross-reactivity) for CEDIA Digoxin:
Digoxigenin: 59.3, B-Acetyldigoxin: 71.3, a-Acetyldigoxin: 67.5, Gitalin: 3.7, Digoxingenin-Mono-Digitoxiside: 100.5, Digitoxin-Bis-Digitoxiside: 77.3, Digitoxin: 17.6, B-Methyldigoxin: 71.3, 3-Epe-Digoxigenin: 37.5, 3-Dehydrodigoxigenin: 47.4, and Epi-Digoxigenin-Glucuronide: 40.5.
Specificity (% cross-reactivity) for TDx Digoxin II:
4.8 for Gitalin; others indicated as N/A or not tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
MAY | 4 1997
Image /page/0/Picture/1 description: The image contains a handwritten sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '97088'. The numbers are written in a bold, cursive style, and they appear to be part of a code or identification number.
510(k) Summary
BOEHRINGER
MANNHEIM
CORPORATIONtroduction
According to the requirements of 21 CFR 807.92, the followingmion 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 8240
Fax: (510) 687-1850
Contact Person: Yvette Lloyd
Date Prepared: March 6, 1997 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.
Device name | Proprietary name: CEDIA® Digoxin Assay
Common name: Homogeneous enzyme immunoassay for the determination of Digoxin.
Classification name: Enzyme immunoassay, Digoxin |
| 3.
Predicate
device | The Boehringer Mannheim CEDIA® 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). |
1
formed.
Image /page/1/Picture/1 description: The image shows a document describing the CEDIA Digoxin Assay. The assay is based on the bacterial enzyme B-galactosidase, which has been genetically engineered into two inactive fragments. The fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, digoxin in the sample competes with analyte conjugated to one inactive fragment of B-galactosidase for antibody binding site.
2
| BOEHRINGER
MANNHEIM
CORPORATION | Intended use | Immunoassay for the in vitro quantitative determination of Digoman
serum and plasma. |
|---------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 6.
Comparison
to predicate
device | The Boehringer Mannheim CEDIA® 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 CEDIA® 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: 0.15 - 4 ng/mL |
3
Differences:
Image /page/3/Picture/1 description: The image shows the logo for Boehringer Mannheim Corporation. The text is stacked in three lines, with "BOEHRINGER" on the top line, "MANNHEIM" on the second line, and "CORPORATION" on the third line. The text is in a bold, sans-serif font.
Comparison
to predicate device cont.
| Feature | CEDIA®
Digoxin | TDx
Digoxin II |
|----------------------------|------------------------------|---------------------------|
| Reaction test
principle | Spectrophotometric
570 nm | Fluorescence Polarization |
| Instrument
required | Hitachi 911 | Abbott TDx |
Performance Characteristics:
| Feature | | CEDIA®
Digoxin | | TDx
Digoxin II | | |
|------------|---------|-------------------------|----------------|-------------------|------|------|
| Precision | | Modified NCCLS (ng/mL): | NCCLS (ng/mL): | | | |
| Level | Level 1 | Level 2 | Level 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 50 | 50 | 50 |
| Within run | 1.0 | 1.7 | 3.8 | 0.70 | 1.44 | 3.66 |
| %CV | 4.25 | 3.45 | 1.45 | 5.75 | 3.15 | 1.87 |
| Total | 1.0 | 1.7 | 3.8 | 0.70 | 1.44 | 3.66 |
| %CV | 6.71 | 4.17 | 2.01 | 7.67 | 3.98 | 1.91 |
4
Image /page/4/Picture/1 description: The image shows the logo for Boehringer Mannheim Corporation. The text is stacked on top of each other, with "Boehringer" on the top line, "Mannheim" on the second line, and "Corporation" on the third line. To the right of the logo is the text "Comparison to predicate device, (cont.)".
Performance Characteristics:
Image /page/4/Picture/8 description: The image is completely black, with no discernible features or content. It appears to be a solid black rectangle, filling the entire frame. There are no shapes, lines, or textures visible within the image. The image lacks any details or elements that could provide further information or context.
ON
Comparison
to predicate
device, (cont.)
| Feature | CEDIA®
Digoxin | TDx
Digoxin II |
|-----------------------------|--------------------------------------------------------|---------------------------------------|
| Lower
Detection
Limit | 0.15 ng/mL | 0.2 ng/mL |
| Linearity | 0.15 - 4 ng/mL | 0.0 - 4.0 ng/mL |
| Method
Comparison | Vs Abbott TDx
Digoxin | Vs Baxter Dade Stratus |
| | Least Squares
$y =0.97x - 0.17$
r=0.9667
N=99 | $y =0.94x + 0.08$
r=0.962
N=200 |
| | Deming's:
$y=1.00x - 0.22$
r=0.9667
N=99 | |
5
Image /page/5/Picture/1 description: This image shows the performance characteristics of CEDIA Digoxin. The table lists interfering substances such as Bilirubin at 66 mg/dL, Hemoglobin at 1000 mg/dL, Triglyceride Lipemia at 100 mg/dL, Total Protein at 10 g/dL, and Rheumatoid Factor at 100 IU/mL. The table also lists specificity with % cross-reactivity for Digoxigenin at 59.3, B-Acetyldigoxin at 71.3, a-Acetyldigoxin at 67.5, Gitalin at 3.7, Digoxingenin-Mono-Digitoxiside at 100.5, Digitoxin-Bis-Digitoxiside at 77.3, Digitoxin at 17.6, B-Methyldigoxin at 71.3, 3-Epe-Digoxigenin at 37.5, 3-Dehydrodigoxigenin at 47.4, and Epi-Digoxigenin-Glucuronide at 40.5.
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TDx
Digoxin II
No interference at:
% Cross-reactivity
20 mg/dL
N/A
N/A
up to 200
not tested
not tested
not tested
up to 200
up to 200
not tested
not tested
not tested
4.8
1000 mg/dL
2500 mg/dL