(127 days)
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No
The summary describes a standard immunoassay system for drug concentration measurement and does not mention any AI or ML components.
No
The device is described as a reagent system for the quantitative determination of certain drugs in human serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as reagents and a calibrator system for the quantitative determination of specific drug concentrations (gentamicin and tobramycin) in human serum or plasma. This type of quantitative measurement of substances in biological samples is characteristic of an in vitro diagnostic (IVD) device, which is used to diagnose or monitor medical conditions.
No
The device description clearly states it is a reagent and calibrator system intended for use with a specific hardware system (Beckman IMMAGE™ Immunochemistry Systems), indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the reagents are for the "quantitative determination of gentamicin in human serum or plasma" and "quantitative determination of tobramycin in human serum or plasma". This involves testing samples taken from the human body in vitro (outside the body) to provide information about a person's health status (in this case, drug levels).
- Device Description: The description reinforces the intended use by stating the reagents are for "quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples".
- Method: The method used is "rate nephelometric inhibition immunoassay", which is a common technique used in in vitro diagnostic testing.
- Predicate Devices: The predicate devices listed (TDx Gentamicin Reagent and TDx Tobramycin Reagent) are also IVD devices, indicating the regulatory pathway for this type of product.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in coniunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.
Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 companson, stability, and imprecision experiments that relate results obtained from the Abbott TDx Reagents to the IMMAGE System Reagents.
Method Comparison Study Results:
Analyte: Gentamicin, Slope: 0.994, Intercept: -0.05, r: 0.998, n: 135, Predicate Method: Abbott TDx Gentamicin
Analyte: Tobramycin, Slope: 1.009, Intercept: -0.12, r: 0.996, n: 94, Predicate Method: Abbott TDx Tobramycin
Stability Study Results: Not legible content beyond table title.
Estimated Within-Run Imprecision: Not legible content beyond table title.
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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§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "BECKMAN" in bold, black letters. The letters are large and fill the frame. The font is sans-serif and appears to be a standard typeface.
FEB | | 1997
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents [Gentamicin (GEN) and Tobramycin (TOB)]
1.0 Submitted By:
Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
03 October 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Gentamicin (GEN) Reagent IMMAGE™ Immunochemistry System Tobramycin (TOB) Reagent Beckman Drug Calibrator 3 Plus
3.2 Classification Names
Gentamicin Test System (21 CFR §862.3450) Tobramycin Test System (21 CFR §862.3900) Calibrator (21 CFR §862.1150)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|-----------------------------|-------------------------------------------------------------|-------------------------------|------------------|
| Gentamicin (GEN)
Reagent | TDx ® ** Gentamicin
Reagent | Abbott* Laboratories,
Inc. | K904226 |
| Tobramycin (TOB)
Reagent | TDx Tobramycin
Reagent | Abbott Laboratories,
Inc. | K904226 |
*Abbott Laboratories, Abbott Park, IL 60064
** Trademark of Abbott Laboratories
Beckman Instruments, Inc.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System TDM (GEN & TOB) Reagents Summary of Safety & Effectiveness
5.0 Description:
The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in coniunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.
Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System | ||
| (GEN & TOB) | ||
| Reagents | Intended use. | Same as Abbott TDx |
| Reagents | ||
| Liquid stable reagents. | ||
| IMMAGE System | ||
| (GEN & TOB) | ||
| Reagents | IMMAGE utilizes nephelometric | |
| inhibition immunoassay | Abbott TDx reagents utilize | |
| fluorescence polarization | ||
| immunoassay | ||
| IMMAGE System | ||
| (GEN & TOB) | ||
| Reagents | Antibody source for IMMAGE GEN | |
| & TOB reagents is mouse. | Antisera source for TDx | |
| Gentamicin and Tobramycin | ||
| is sheep. |
2
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 companson, stability, and imprecision experiments that relate results obtained from the Abbott TDx Reagents to the IMMAGE System Reagents.
Method Comparison* Study Results IMMAGE System GEN, TOB, PHY, and THE Redgents
| Analyte | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|
| Gentamicin | 0.994 | -0.05 | 0.998 | 135 | Abbott TDx |
| Gentamicin | |||||
| Tobramycin | 1.009 | -0.12 | 0.996 | 94 | Abbott TDx |
| Tobramycin |
- Deming Regression statistics used
Stability Study Results
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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.
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