(155 days)
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No
The summary describes a reagent for a quantitative immunoassay system, focusing on standard analytical performance metrics and comparisons to a predicate device. There is no mention of AI or ML.
No
The device is a reagent for quantitative determination of Immunoglobulin G in urine, serving as a diagnostic tool rather than a therapeutic intervention.
Yes
The device is intended for the "quantitative determination of Immunoglobulin G in urine," which is a measurement used to aid in diagnosis or prognosis.
No
The device is described as a reagent used with an immunochemistry system, indicating it is a chemical substance and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the quantitative determination of Immunoglobulin G in urine". This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description reinforces this by stating it's for "quantitative determination of Immunoglobulin G in human urine samples".
- Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments, which are typical evaluations for IVD devices.
- Predicate Device: The predicate device listed (K951635 Beckman Immunoglobulin G (IGG) Test System (Urine application)) is also an IVD, indicating that this device falls within the same regulatory category.
The core function of the device is to analyze a biological sample (urine) to provide diagnostic information (quantitative determination of Immunoglobulin G), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quartitative determination of Immunoglobulin G in urine by rate nephelometry.
Product codes
21 CFR § 866.5510
Device Description
The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.
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
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 Immunoglobulin G Test System Reagent to the IMMAGE IGU Reagent.
Method Comparison Study Results:
Analyte: IMMAGE IGU Reagent
Slope: 1.00
Intercept: 0.00
r: 0.998
n: 115
Predicate: Beckman (IGG) Test System
Stability Study Results:
Product Claim for IMMAGE IGU: 24 month shelf-life, 14 day open container stability, 14 day calibration stability.
Estimated Within-Run Imprecision:
Level 1: Mean = 0.38, SD = 0.038, %CV = 10.2, Number of Results = 80
Level 2: Mean = 2.66, SD = 0.071, %CV = 2.7, Number of Results = 80
Level 3: Mean = 5.20, SD = 0.140, %CV = 2.7, Number of Results = 80
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
BECKMAN
MAR - 6 1997
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent
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
Date Submitted: 2.0
30 September 1996
3.0 Device Name(s):
3.1 Proprietary Name
IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent
3.2 Classification Name
Immunoglobulins A, G, M, D, and E immunological test system (21 CFR § 866.5510)
Predicate Device(s): 4.0
Beckman Immunoglobulin G (IGG) Test System (Urine application) K951635
5.0 Description:
The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.
6.0 Intended Use:
The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quartitative determination of Immunoglobulin G in urine by rate nephelometry.
1
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 | ||
| IGU Reagent | Analytic Range | Same as |
| Beckman IGG Test System | ||
| reagent | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| IGU Reagent | Antigen excess testing | IMMAGE IGU has antigen |
| excess testing solution | ||
| included in the reagent | ||
| cartridge, while the Beckman | ||
| IGG Test System requires off- | ||
| line preparation of the | ||
| solution. | ||
| Antibody concentration | IMMAGE IGU has a higher | |
| antibody concentration than | ||
| the Beckman IGG Test | ||
| System |
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent Summary of Safety & Effectiveness
Summary of Performance Data: 8.0
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 Immunoglobulin G Test System Reagent to the IMMAGE IGU Reagent.
Method Comparison Study Results IMMAGE IGU Reagent vs. Beckman Immunoglobulin G Kit Reagent
| Analyte | Slope | Intercept | r | n | Predicate |
|---|---|---|---|---|---|
| IMMAGE IGU | |||||
| Reagent | 1.00 | 0.00 | 0.998 | 115 | Beckman |
| (IGG) Test | |||||
| System |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE IGU | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Within-Run Imprecision
| MATERIAL | | | %CV | Number of
Results |
|----------|------|-------|------|----------------------|
| | | | | |
| Level 1 | 0.38 | 0.038 | 10.2 | 80 |
| Level 2 | 2.66 | 0.071 | 2.7 | 80 |
| Level 3 | 5.20 | 0.140 | 2.7 | 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.