(38 days)
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No
The summary describes a reagent kit for a standard immunochemistry system using rate nephelometry, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for the quantitative determination of transferrin concentrations, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the quantitative determination of transferrin concentrations in human serum samples, which is a measurement used to aid in the diagnosis or monitoring of clinical conditions.
No
The device description explicitly states it is a "reagent kit" containing a cartridge of reagent, evaporation caps, and a barcode card, which are physical components, 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 concentrations in human serum samples." This involves testing biological samples (serum) outside of the body (in vitro).
- Device Description: It describes a "reagent" used in conjunction with a "system" for performing this test. Reagents used for analyzing biological samples are a core component of IVDs.
- Performance Studies: The document details performance studies like method comparison, stability, and imprecision, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: It lists a "Predicate Device" which is another "Immunochemistry Systems TRF Transferrin Reagent." Predicate devices are used in the regulatory process for IVDs to demonstrate substantial equivalence to existing legally marketed devices.
All of these points strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The IMMAGE™ Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.
Product codes
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Device Description
The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is used in the determination of transferrin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
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
human serum samples
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
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 Beckman's Immunochemistry System TRF Transferrin (on ARRAY) Reagent to the IMMAGE System TRF Reagent.
Method Comparison Study Results:
IMMAGE TRF Reagent vs. Beckman TRF Transferrin Reagent (on ARRAY)
Analyte: IMMAGE TRF, Slope: 0.990, Intercept: 0.692, r: 0.994, Predicate: Beckman's TRF Transferrin Reagent on the ARRAY® Systems
Stability Study Results:
IMMAGE TRF Reagent System: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Estimated Within-Run Imprecision:
TRF Reagent Level 1: MEAN (mg/dL) 241, SD (mg/dL) 7.4, %CV 3.1, Number of Results 80
TRF Reagent Level 2: MEAN (mg/dL) 361, SD (mg/dL) 14.0, %CV 3.9, Number of Results 80
TRF Reagent Level 3: MEAN (mg/dL) 653, SD (mg/dL) 18.9, %CV 2.9, Number of Results 80
Key Metrics
Not Found
Predicate Device(s)
Beckman Immunochemistry Systems TRF Transferrin Reagent
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT 7 1996
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent Summary of Safety & Effectiveness
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
1.0 Submitted By:
Margie George Proiect Manager, System Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759
2.0 Date Submitted:
30 August 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
3.2 Classification Names
Transferrin immunological test svstem (21 CFR 866.5880)
4.0 Predicate Device(s):
Beckman Immunochemistry Systems TRF Transferrin Reagent
5.0 Description:
The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is used in the determination of transferrin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific Calibrators and control materials are purchased bar code card. separately.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent Summary of Safety & Effectiveness
6.0 Intended Use:
:
The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.
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 |
|---|---|---|
| SIMILARITIES | ||
| IMMAGE | ||
| System (TRF) | ||
| Reagent | Assay method - rate nephelometry | Same as Beckman's |
| Immunochemistry System | ||
| Transferrin TRF Reagent | ||
| as run on the ARRAY® | ||
| System | ||
| Analytic Range 75 - 750 mg/dL | ||
| Extended Range 12.5 - 4,500 mg/dL | ||
| Sample and reagent ratios | ||
| Antibody | ||
| Shelf life of 24 months | ||
| (stored at 2 -8°C) | ||
| DIFFERENCES | ||
| IMMAGE | ||
| System (TRF) | ||
| Reagent | Reaction Temperature | IMMAGE System TRF |
| assays run at 37°C and | ||
| the predicate runs at | ||
| 26.7°C | ||
| Reagent container | IMMAGE reagent is | |
| stored in a plastic | ||
| cartridge where as the | ||
| predicate is stored in | ||
| glass |
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 comparison, stability, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRF Transferrin (on ARRAY) Reagent to the IMMAGE System TRF Reagent.
Method Comparison Study Results
IMMAGE TRF Reagent vs. Beckman TRF Transferrin Reagent (on ARRAY)
| Analyte | Slope | Intercept | r | Predicate |
|---|---|---|---|---|
| IMMAGE | ||||
| TRF | 0.990 | 0.692 | 0.994 | Beckman's TRF |
| Transferrin Reagent on | ||||
| the ARRAY® Systems |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE TRF Reagent System | 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 |
|-------------|-----------------|---------------|-----|-------------------------|
| TRF Reagent | | | | |
| Level 1 | 241 | 7.4 | 3.1 | 80 |
| Level 2 | 361 | 14.0 | 3.9 | 80 |
| Level 3 | 653 | 18.9 | 2.9 | 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.