(121 days)
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No
The summary describes a reagent kit for a laboratory immunoassay system, focusing on chemical reactions and quantitative determination of a substance. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is used for quantitative determination of albumin in urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use" states that the reagent is for the "quantitative determination of micro quantities of albumin in urine," which is a measurement used to aid in the diagnosis or monitoring of a disease.
No
The device is a reagent kit intended for use with a specific hardware system (Beckman IMMAGE™ Immunochemistry Systems) to perform a quantitative determination. It is a consumable chemical product, not a software-only device.
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 micro quantities of albumin 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 micro quantities of micro albumin in human urine samples."
- Method: It uses "rate nephelometry," which is a laboratory technique for measuring the concentration of substances in a solution.
- System: It's used on the "Beckman IMMAGE™ Immunochemistry Systems," which are laboratory instruments designed for performing diagnostic tests.
- Reagent and Calibrator: It requires a specific reagent and calibrator, which are components typically used in IVD tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin 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 MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro albumin in in human urine samples on Beckman's IMMAGE™ quantities of Immunochemistry System.
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)
Method Comparison Study Results:
Analyte: IMMAGE MA Reagent
Sample Type: urine
Slope: 0.957
Intercept: -0.03
r: 0.991
n: 109
Predicate Method: Beckman MA Reagent
Stability Study Results:
IMMAGE MA: month shelf-life, 14 day open container stability, day calibration stability
Estimated Imprecision:
Within-Run Imprecision:
Level 1: Mean (mg/dL) 0.56, S.D. (mg/dL) 0.042, %C.V. 7.5, N 80
Level 2: Mean (mg/dL) 2.25, S.D. (mg/dL) 0.107, %C.V. 4.7, N 80
Level 3: Mean (mg/dL) 3.19, S.D. (mg/dL) 0.063, %C.V. 2.0, N 80
Total Imprecision:
Level 1: Mean (mg/dL) 0.56, S.D. (mg/dL) 0.055, %C.V. 9.8, N 80
Level 2: Mean (mg/dL) 2.25, S.D. (mg/dL) 0.121, %C.V. 5.4, N 80
Level 3: Mean (mg/dL) 3.19, S.D. (mg/dL) 0.073, %C.V. 2.3, N 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
BECKMAN
1997
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Microalbumin (MA) 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
2.0 Date Submitted:
16 December 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent
3.2 Classification Name
Albumin immunological test system (21 CFR § 866.5040)
Predicate Device(s): 4.0
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|-----------------------------------------------|-------------------------------------------|------------------------------|------------------|
| IMMAGE System
Microalbumin (MA)
Reagent | Beckman MA
Microalbumin Reagent
Kit | Beckman Instruments,
Inc. | K895883 |
Beckman Instruments, Inc.
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twx: 910-592-1260 • telex: 06-78413
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent Summary of Safety & Effectiveness
5.0 Description:
The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro albumin in in human urine samples on Beckman's IMMAGE™ quantities of Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in
conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.
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 | ||
| MA Reagent | Analytic Range | Same as Beckman |
| Microalbumin Reagent Kit | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| MA Reagent | Antigen excess testing solution | IMMAGE MA has antigen |
| excess testing solution | ||
| included in the reagent | ||
| cartridge, while the Beckman | ||
| Microalbumin Reagent Kit | ||
| requires off-line preparation of | ||
| the solution. | ||
| Antibody concentration | IMMAGE MA has a higher | |
| antibody concentration than | ||
| the Beckman Microalbumin | ||
| Reagent Kit |
file: ma510k.sse
2
Beckman Instruments, Inc., Section 510(k) Notification Bockman munochemistry System Microalbumin (MA) 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. Substantial Squivalence to Shornethod Companson, stability, and imprecision experiments that results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results IMMAGE Microalbumin (MA) Reagent
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| MA | ||||||
| Reagent | urine | 0.957 | -0.03 | 0.991 | 109 | Beckman |
| MA Reagent |
Stability Study Results
| ALLE ARREAL CONTRACTOR COLLECTION CONTRACT CONTROLLERS CONTROLLERS CONTROLLED CONSULTER CONTROLLERS CONTRACTOR CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT
Comments of the contract and the contract and the contraction of the comments of the comments of the comments of the comments of the comments of the comments of the comments
BEATH THE STATE FOR A FRANCE FOR A F E COLLECT COOCLE EXCELLAND FILG A COLLECT
| eagent | Productional | |
|---|---|---|
| IMMAGE MA | month shelf-life | |
| 14 day open container stability | ||
| day calibration stability |
Estimated Imprecision
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 0.56 | 0.042 | 7.5 | 80 |
| Level 2 | 2.25 | 0.107 | 4.7 | 80 |
| Level 3 | 3.19 | 0.063 | 2.0 | 80 |
| Total Imprecision | ||||
| Level 1 | 0.56 | 0.055 | 9.8 | 80 |
| Level 2 | 2.25 | 0.121 | 5.4 | 80 |
| Level 3 | 3.19 | 0.073 | 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.
file: ma510k.sse