(166 days)
Not Found
No
The summary describes a reagent for a quantitative immunoassay system, focusing on standard analytical performance metrics and equivalence to a predicate device. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a reagent for in vitro diagnostic (IVD) use, intended for quantitative determination of transferrin in urine, which is a diagnostic purpose and not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the reagent is "intended for the quantitative determination of transferrin in urine", which is a measurement used for diagnostic purposes.
No
The device is described as a reagent kit for use with an immunochemistry system, indicating it is a physical chemical product, 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 transferrin in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (transferrin levels).
- Device Description: The description reinforces this by stating it's for the "quantitative determination of transferrin in human urine samples."
- Nature of the Test: Measuring transferrin in urine is a laboratory test performed on a biological sample.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine 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 Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Unine Protein Calibrator, is intended for the quantitative determination of transferin in urine by rate nephelometry.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of transferrin in human urine samples.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent.
Method Comparison Study Results IMMAGE TRU Reagent vs. Beckman Transferrin Kit Reagent
Data is presented in a table that is not fully parseable due to formatting issues.
Stability Study Results
IMMAGE TRU Reagent:
- 24 month shelf-life
- 14 day open container stability
- 14 day calibration stability
Estimated Within-Run Imprecision
TRU Reagent:
- Level 1: MEAN (mg/dL) 0.38, SD (mg/dL) 0.010, %CV 2.7, Number of Results 80
- Level 2: MEAN (mg/dL) 1.55, SD (mg/dL) 0.041, %CV 2.6, Number of Results 80
- Level 3: MEAN (mg/dL) 3.02, SD (mg/dL) 0.077, %CV 2.6, 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.
Beckman Transferrin Kit (Urine application) K926272
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.
Not Found
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).
Not Found
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
0
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent
MAR 1 9 1997
Submitted By: 1.0
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
Date Submitted: 2.0
30 September 1996
3.0 Device Name(s):
3.1 Proprietary Name
IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent
3.2 Classification Name
Transferrin Test System (21 CFR § 866.5880)
Predicate Device(s): 4.0
Beckman Transferrin Kit (Urine application) K926272
5.0 Description:
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of transferrin in human urine samples.
6.0 Intended Use:
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Unine Protein Calibrator, is intended for the quantitative determination of transferin in urine by rate nephelometry.
Beckman Instruments, Inc.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent Summary of Safety & Effectiveness
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| IMMAGE System | ||
| TRU Reagent | Analytic Range | Same as |
| Beckman Transfermin Kit | ||
| reagent | ||
| IMMAGE System | ||
| TRU Reagent | Nephelometric methodology | |
| IMMAGE System | ||
| TRU Reagent | Antibody source (goat) | |
| DIFFERENCES | ||
| IMMAGE System | ||
| TRU Reagent | Antigen excess testing | IMMAGE TRU has antigen |
| excess testing solution | ||
| included in the reagent | ||
| cartridge, while the Beckman | ||
| Transfermin Kit requires off-line | ||
| preparation of the solution. | ||
| IMMAGE System | ||
| TRU Reagent | Antibody concentration | IMMAGE TRU has a higher |
| antibody concentration than | ||
| the Beckman Transfermin Kit |
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 Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent.
Method Comparison Study Results IMMAGE TRU Reagent vs. Beckman Transferrin Kit Reagent
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Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE TRU | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Within-Run Imprecision
| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
|---|---|---|---|---|
| TRU Reagent | ||||
| Level 1 | 0.38 | 0.010 | 2.7 | 80 |
| Level 2 | 1.55 | 0.041 | 2.6 | 80 |
| Level 3 | 3.02 | 0.077 | 2.6 | 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.