(137 days)
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No
The summary describes a traditional immunoassay system using nephelometry for quantitative determination of immunoglobulins. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The performance studies focus on method comparison, stability, and imprecision, which are standard evaluations for this type of device.
No.
The device is intended for the quantitative determination of human immunoglobulins (IGG, IGA, IGM) by rate nephelometry, which is a diagnostic measurement and not a therapeutic action.
Yes
The device is intended for the quantitative determination of human immunoglobulin G, A, and M, which are biomarkers used in diagnostic testing for various medical conditions.
No
The device is described as reagents intended for use on a specific hardware system (Beckman's IMMAGE Immunochemistry System). This indicates it is a component of a larger hardware-based system, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the reagents are for the "quantitative determination of human immunoglobulin G, A, and M" using a specific system. This involves testing biological samples (human immunoglobulin) outside of the body.
- Device Description: The description confirms the reagents are used in conjunction with a system for this quantitative determination.
- Performance Studies: The performance studies involve testing the reagents with serum and CSF samples, which are biological specimens. The studies evaluate metrics like method comparison and imprecision, which are typical for IVD performance evaluation.
The core function of the device is to analyze biological samples in vitro (outside the living organism) to provide diagnostic information (quantitative levels of immunoglobulins). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE 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)
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 results obtained from the Immunochemistry Systems Reagents to the IMMAGE System Reagents.
Method Comparison Study Results:
IMMAGE IGG Reagent (Serum sample, n=323): Slope 1.037, Intercept -16.6, r 0.971
IMMAGE IGG Reagent (CSF sample, n=100): Slope 1.037, Intercept 0.11, r 0.985
IMMAGE IGA Reagent (Serum sample, n=289): Slope 1.031, Intercept -2.07, r 0.990
IMMAGE IGM Reagent (Serum sample, n=247): Slope 1.001, Intercept -4.29, r 0.998
Stability Study Results:
IMMAGE IGG, IGA, & IGM: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Estimated Within-Run Imprecision:
Immunogiobulin G (IGG) (Serum sample, Level 1): Mean 549, Percentage C.V. 2.0 (ARt(R) 10.8)
Immunogiobulin G (IGG) (Serum sample, Level 2): Mean 1293 (ARt(R) 203)
Immunogiobulin G (IGG) (Serum sample, Level 3): Mean 2362 (ARt(R) 51)
Immunoglobulin G (IGG) Reagent (CSF sample):
Level 1: Mean 1.62 mg/dL, S.D. 0.086 mg/dL, 5.3 %C.V., N 30
Level 2: Mean 7.85 mg/dL, S.D. 0.104 mg/dL, 1.3 %C.V., N 30
Level 3: Mean 13.5 mg/dL, S.D. 0.52 mg/dL, 3.9 %C.V., N 30
Immunoglobulin A (IGA) Reagent (level 7): Mean 400
Immunoglobulin M (IGM) Reagent (level K): Mean 0.6
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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§ 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
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents
1.0 Submitted By:
K963868 FEB 10 1997
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:
25 September-1996
Device Name(s): 3.0
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Immunoglobulin G (IGG) Reagent IMMAGE™ Immunochemistry System Immunoglobulin A (IGA) Reagent IMMAGE™ Immunochemistry System Immunoglobulin M (IGM) Reagent
3.2 Classification Names
Immunoalobulin G Test System (21 CFR §866.5510) Immunoglobulin A Test System (21 CFR §866.5510) Immunoglobulin M Test System (21 CFR §866.5510)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|-----------------------------------|-----------------------------------------------------------|------------------------------|------------------|
| Immunoglobulin G
(IGG) Reagent | Immunochemistry
Systems
Immunoglobulin G
Reagent | Beckman Instruments,
Inc. | K771603 |
| Immunoglobulin A
(IGA) Reagent | Immunochemistry
Systems
Immunoglobulin A
Reagent | Beckman Instruments,
Inc. | K771603 |
| Immunoglobulin M
(IGM) Reagent | Immunochemistry
Systems
Immunoglobulin M
Reagent | Beckman Instruments,
Inc. | K771603 |
Beckman Instruments, Inc.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents Summary of Safety & Effectiveness
5.0 Description:
The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.
The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M 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:
SIMILARITIES | Comments |
|------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------|
| IMMAGE System
(IGG, IGA, & IGM)
Reagents | Reagent antibody formulation | Same as Immunochemistry
Systems
(IGG, IGA, & IGM) Reagents |
| | Nephelometric rate methodology | |
| | Reagents are curve fit with the
same standards | |
| | DIFFERENCES | |
| IMMAGE System
(IGG, IGA, & IGM)
Reagents | Antibody titer | Immunochemistry Systems
(IGG, IGA, & IGM) reagents
use a higher antibody titer. |
| IMMAGE System
(IGG, IGA, & IGM)
Reagents | Reaction Temperature | Immunochemistry Systems
operate at 26°C, IMMAGE
System operates at 37°C |
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 results obtained from the Immunochemistry Systems Reagents to the IMMAGE System Reagents.
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| IGG Reagent | Serum | 1.037 | -16.6 | 0.971 | 323 | Immunochemistry |
| Systems | ||||||
| IGG Reagent | ||||||
| IMMAGE | ||||||
| IGG Reagent | CSF | 1.037 | 0.11 | 0.985 | 100 | Immunochemistry |
| Systems | ||||||
| IGG Reagent | ||||||
| IMMAGE | ||||||
| IGA Reagent | Serum | 1.031 | -2.07 | 0.990 | 289 | Immunochemistry |
| Systems | ||||||
| IGA Reagent | ||||||
| IMMAGE | ||||||
| IGM | ||||||
| Reagent | Serum | 1.001 | -4.29 | 0.998 | 247 | Immunochemistry |
| Systems | ||||||
| IGM Reagent |
Method Comparison Study Results IMMAGE System IGG, IGA, & IGM Reagents
Stability Study Results
| Report | Product Claim |
|---|---|
| IMMAGE IGG, IGA, & IGM | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
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3
Estimated Within-Run Imprecision
| ART (R) | A Book Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Ch | a product to the comments of | ||
|---|---|---|---|---|
| Immunogiobulin G fiGG) (Serum sample, | ||||
| Level 1 | 549 | 10.8 | 2.0 | |
| Level 2 | 1293 | 203 | ||
| Level 3 | 2362 | 51 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Immunoglobulin G (IGG) Reagent (CSF sample) | ||||
| Level 1 | 1.62 | 0.086 | 5.3 | 30 |
| Level 2 | 7.85 | 0.104 | 1.3 | 30 |
| Level 3 | 13.5 | 0.52 | 3.9 | 30 |
|
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| 1000 000 000 | |||||||
|---|---|---|---|---|---|---|---|
| Immunoalobulin A (IGA) Reagent | |||||||
| evel | |||||||
| Level 7 | 400 | ||||||
| evel 3 |
| tean (mg/dL)
.
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| Carlo Concession | |||||||
|---|---|---|---|---|---|---|---|
| Immunoglobulin M (IGM) Re | |||||||
| eve | |||||||
| evel K | 0.6 |
This summary of safety and effectiveness is being submitted in accordance with the This Summary of Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.