(128 days)
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No
The summary describes a turbidimetric immunoassay reagent and system for quantitative determination of digoxin, which is a standard laboratory chemistry technique and does not mention any AI/ML components.
No.
This device is intended for the quantitative determination of digoxin in human serum and plasma samples, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is intended for the quantitative determination of digoxin in human serum and plasma samples, which is a diagnostic measurement used to assess drug levels in the body for patient management.
No
The device is a reagent intended for use with a specific immunochemistry system, indicating it is a chemical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of digoxin in human serum and plasma samples by turbidimetric immunoassay." This involves testing biological samples in vitro (outside the body) to provide information about a person's health status (in this case, the level of digoxin in their blood).
- Device Description: The description reinforces that it's for "quantitative determination of digoxin concentrations in human serum and plasma samples," again highlighting the in vitro testing of biological samples.
- Method of Analysis: The method used is "turbidimetric immunoassay," which is a common technique used in in vitro diagnostic testing.
- Predicate Devices: The predicate devices listed (Behring Diagnostics N Latex RF and Abbott TDx Digoxin II Reagent) are also IVD devices, indicating that this device falls within the same regulatory category.
Therefore, based on the provided information, the IMMAGE Immunochemistry System Digoxin (DIG) Reagent is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plaama samples by turbidimetric immunossay. This assay is designed for use with the IMMAGE Immunochemistry System.
Product codes
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Device Description
The IMMAGE System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of digoxin concentrations in human serum and plasma semples.
Mentions image processing
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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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Abbott Digoxin II Reagent to the IMMAGE DIG Reagent.
Method Comparison Study Results: IMMAGE DiG Reagent vs. Abbott Digoxin II Reagent using Deming regression analysis.
Stability Study Results:
IMMAGE DIG: 18 months shelf-life, 14-day on board.
Drug Calibrator 2: 24 months sholf-life, 14-day calibration.
Estimated Within-Run Improcision:
Level 1: MEAN (U/mL) 0.87, SD (U/mL) 0.042, MCV 4.8, Number of Results 15
Level 1: MEAN (U/mL) 1.32, SD (U/mL) 0.068, MCV 5.1, Number of Results 80
Level 2: MEAN (U/mL) 2.63, SD (U/mL) 0.079, MCV 3.0, Number of Results 80
Level 3: MEAN (U/mL) 4.19, SD (U/mL) 0.095, MCV 2.3, Number of Results 80
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
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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
200 South Kraemer Boulevard, Box 8000, Brea, CA 92622-8000 • (714) 993-5321
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent
Sybmitted By: 1.0
K96 3062
Sheri Hall Manager, Premarket Regulatory Margie George Project Manager, Systems Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92622-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759
DEC 13 1996
2.0 Date Submitted:
04 Decamber 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Digoxin Reagent Beckman Drug Calibrator 2
3.2 Classification Names
Digoxin immunological test system (21 CFR 866.5775) Clinical toxicology calibrator (21 CFR 862.3200)
4.0 Predicate Device(s):
Behring Diagnostics N Latex RF. K942328 Abbott TDx Digoxin II Reagent, K882233
5.0 Description:
The IMMAGE System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of digoxin concentrations in human serum and plasma semples.
6.0 Intended Use:
The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plaama samples by turbidimetric immunossay. This assay is designed for use with the IMMAGE Immunochemistry System.
1
. '
Comparison to Prodicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Specific Characteristics | Comments |
|---|---|---|
| DIG Reagent | Intended use for the | |
| measurement of digoxin at 37°C | Same as TDx | |
| Digoxin II Reagent | ||
| Reagent measures digoxin in | ||
| both human plasma and serum | ||
| samples | Same as TDx | |
| Digoxin II Reagent | ||
| Analytic Range of 0.2 to 5 | ||
| ng/mL | Same as TDx | |
| Digoxin II Reagent | ||
| DIG Reagent | Assay Type | IMMAGE System DIG Reagent uses |
| turbidimetric inhibition immunoassay | ||
| technology while the predicate uses | ||
| fluorescence polarization | ||
| immunoassay technology | ||
| Sample Pretreatment | IMMAGE System DIG Reagent does | |
| not require sample pretreatment | ||
| while the predicate requires sample | ||
| pretreatment |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Abbott Digoxin II Reagent to the IMMAGE DIG Reagent.
Method Comparison Study Results® IMMAGE DiG Reagent vs. Abbott Digoxin II Reagent
| MARKET STATE STATE CONTRACT COLLECTION CONTROLLERS CARAL CARADHAN CARADHING CONTROLLER | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
|---|---|---|---|---|
| IMMAGE | ||||
| DIG | 1.011 + 0.037 | 0.047 + 0.0016 | DISTE | 001 DX |
| Digoxin | ||||
| . |
· Deming regression analysis
Stability Study Results
| ababa ( bone angena 1 ( 1 ( 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = | |
|---|---|
| IMMAGE DIG | 18 months shelf-life |
| 14-day on board | |
| Drug Calibrator 2 | 24 months sholf-life |
| 14-day calibration |
2
Estimated Within-Run Improcision
| MEAN (U/mL) | SD (U/mL) | MCV | Number of Results | |
|---|---|---|---|---|
| Level 1 | 0.87 | 0.042 | 4.8 | 15 |
| Level 1 | 1.32 | 0.068 | 5.1 | 80 |
| Level 2 | 2.63 | 0.079 | 3.0 | 80 |
| Level 3 | 4.19 | 0.095 | 2.3 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.