(158 days)
Beckman Immunochemistry Systems ALB Albumin Reagent
Beckman Albumin Reagent (ALB) on the ARRAY Systems, IMMAGE System ALB Reagent
No
The summary describes a reagent and system for quantitative determination of albumin using rate nephelometry, a standard laboratory technique. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) reagent used for quantitative determination of albumin, not a therapeutic device designed to treat or cure a disease.
Yes
This device is intended for the quantitative determination of human albumin concentrations, which provides information for diagnosis and monitoring of medical conditions.
No
The device description clearly 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 human albumin concentrations in human serum and CSF samples." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes a "reagent kit" used for this determination, which is a typical component of an IVD.
- Method: The method used is "rate nephelometry," which is a laboratory technique for analyzing samples.
- Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments conducted on serum and CSF samples, all of which are standard for evaluating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" which is also an "Immunochemistry Systems ALB Albumin Reagent" further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Albumin (ALB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and CSF samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
Product codes
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Device Description
The IMMAGE Immunochemistry System Albumin (ALB) Reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and cerebrospinal fluid (CSF) samples. 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
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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 THE data 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 the Beckman Immunochemistry System ALB Albumin (on ARRAY) Reagent to the IMMAGE System ALB Reagent.
Method Comparison Study Results IMMAGE ALB Reagent vs. Beckman Albumin Reagent (ALB) on ARRAY:
- Analyte: IMMAGE ALB, Sample Type: Serum, Slope: 1.020, Intercept: 10.3, r: 0.997, n: 164, Predicate: Beckman Albumin Reagent (ALB) on the ARRAY Systems
- Analyte: IMMAGE ALB, Sample Type: CSF, Slope: 0.990, Intercept: 0.692, r: 0.994, n: 101, Predicate: Beckman Albumin Reagent (ALB) on the ARRAY Systems
Stability Study Results:
- Reagent: IMMAGE ALB Reagent System, Product Claim: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Precision Study Results IMMAGE ALB Reagent (Serum):
- Material: Level 1, Within Run Precision: Mean (mg/dL) 2268, SD (md/dL) 40.4, %CV 1.8, N 80
- Material: Level 2, Within Run Precision: Mean (mg/dL) 3563, SD (md/dL) 56.6, %CV 1.6, N 80
- Material: Level 3, Within Run Precision: Mean (mg/dL) 4996, SD (md/dL) 115.2, %CV 2.3, N 80
- Material: Level 1, Total Precision: Mean (mg/dL) 2268, SD (md/dL) 55.4, %CV 2.4, N 80
- Material: Level 2, Total Precision: Mean (mg/dL) 3563, SD (md/dL) 68.5, %CV 1.9, N 80
- Material: Level 3, Total Precision: Mean (mg/dL) 4996, SD (md/dL) 121.2, %CV 2.4, N 80
Precision Study Results IMMAGE ALB Reagent (CSF):
- Material: Level 1, Within Run Precision: Mean (mg/dL) 5.13, SD (md/dL) 0.227, %CV 4.4, N 30
- Material: Level 2, Within Run Precision: Mean (mg/dL) 12.5, SD (md/dL) 0.53, %CV 4.2, N 30
- Material: Level 3, Within Run Precision: Mean (mg/dL) 20.7, SD (md/dL) 0.71, %CV 3.4, N 30
- Material: Level 1, Total Precision: Mean (mg/dL) 5.13, SD (md/dL) 0.356, %CV 6.9, N 30
- Material: Level 2, Total Precision: Mean (mg/dL) 12.5, SD (md/dL) 0.58, %CV 4.6, N 30
- Material: Level 3, Total Precision: Mean (mg/dL) 20.7, SD (md/dL) 0.87, %CV 4.2, N 30
Key Metrics
Not Found
Predicate Device(s)
Beckman Immunochemistry Systems ALB Albumin Reagent
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Albumin (ALB) Reagent Summary of Safety & Effectiveness
APR 2 9 1997
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Albumin (ALB) Reagent
1.0 Submitted By:
Frank Marte, R.A.C. Sr. Requlatory Affairs Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-4406 FAX: (714) 961-4457
2.0 Date Submitted:
20 November 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Albumin (ALB) Reagent
3.2 Classification Names
Albumin immunological test system (21 CFR 866.5040)
4.0 Predicate Device(s):
Beckman Immunochemistry Systems ALB Albumin Reagent
5.0 Description:
The IMMAGE Immunochemistry System Albumin (ALB) Reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and cerebrospinal fluid (CSF) samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
1
6.0 Intended Use:
The IMMAGE Immunochemistry System Albumin (ALB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and CSF samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
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 (ALB) | ||
| Reagent | Assay method - rate nephelometry | Same as Beckman's |
| Immunochemistry System | ||
| Albumin ALB Reagent as | ||
| run on the ARRAY® | ||
| System | ||
| Serum: | ||
| Analytic Range 800 - 6000 mg/dL | ||
| Extended Range 22.2 - 6000 mg/dL | ||
| CSF: | ||
| Analytic Range 3.7 - 27.8 mg/dL | ||
| Sample and reagent ratios | ||
| Antibody | ||
| Shelf life of 24 months | ||
| (stored at 2 -8°C) | ||
| DIFFERENCES | ||
| IMMAGE | ||
| System (ALB) | ||
| Reagent | Reaction Temperature | IMMAGE System ALB |
| assays run at 37°C and | ||
| the predicate runs at | ||
| 26.7°C | ||
| Antigen excess solution (AGXS) | IMMAGE System ALB | |
| Reagent AGXS is | ||
| prediluted and present in | ||
| the reagent cartridge | ||
| while the predicate | ||
| requires off-line | ||
| preparation of the solution |
2
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness THE data 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 the Beckman Immunochemistry System ALB Albumin (on ARRAY) Reagent to the IMMAGE System ALB Reagent.
Method Comparison Study Results IMMAGE ALB Reagent vs. Beckman Albumin Reagent (ALB) on ARRAY
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| ALB | Serum | 1.020 | 10.3 | 0.997 | 164 | Beckman |
| Albumin | ||||||
| Reagent (ALB) | ||||||
| on the | ||||||
| ARRAY® | ||||||
| Systems | ||||||
| IMMAGE | ||||||
| ALB | CSF | 0.990 | 0.692 | 0.994 | 101 | Beckman |
| Albumin | ||||||
| Reagent (ALB) | ||||||
| on the | ||||||
| ARRAY® | ||||||
| Systems |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE ALB Reagent | |
| System | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
3
Precision Study Results IMMAGE ALB Reagent
| Material
Serum | Mean
(mg/dL) | SD (md/dL) | %CV | N |
|----------------------|-----------------|------------|-----|----|
| Within Run Precision | | | | |
| Level 1 | 2268 | 40.4 | 1.8 | 80 |
| Level 2 | 3563 | 56.6 | 1.6 | 80 |
| Level 3 | 4996 | 115.2 | 2.3 | 80 |
| Total Precision | | | | |
| Level 1 | 2268 | 55.4 | 2.4 | 80 |
| Level 2 | 3563 | 68.5 | 1.9 | 80 |
| Level 3 | 4996 | 121.2 | 2.4 | 80 |
Precision Study Results IMMAGE ALB Reagent
| Material CSF | Mean (mg/dL) | SD (md/dL) | %CV | N |
|---|---|---|---|---|
| Within Run Precision | ||||
| Level 1 | 5.13 | 0.227 | 4.4 | 30 |
| Level 2 | 12.5 | 0.53 | 4.2 | 30 |
| Level 3 | 20.7 | 0.71 | 3.4 | 30 |
| Total Precision | ||||
| Level 1 | 5.13 | 0.356 | 6.9 | 30 |
| Level 2 | 12.5 | 0.58 | 4.6 | 30 |
| Level 3 | 20.7 | 0.87 | 4.2 | 30 |
This summary of safety and effectiveness iss being submitted in This "summary" of "Salesy and" of the Safe Medical Device Act of 1990
accordance with the requirements of the Safe Medical Device Act of 1990 accordantoo with the regulation 21 CFR 807.92.