(90 days)
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No
The document describes a reagent and system for quantitative determination of rheumatoid factor using rate nephelometry, a standard laboratory technique. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on standard analytical validation metrics like method comparison, stability, and imprecision, not AI/ML model performance.
No.
The device is a reagent used for diagnostic testing (quantitative determination of human rheumatoid factor concentrations), not for treating or preventing a disease or condition.
Yes
The device is intended for the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples, which is a measurement used for diagnostic purposes (e.g., diagnosing rheumatoid arthritis).
No
The device is a reagent intended for use with a specific hardware system (IMMAGE Immunochemistry System) for laboratory testing, not a standalone software application.
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 rheumatoid factor concentrations in human serum and plasma samples." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description reinforces that it's a "reagent" designed for use with an "Immunochemistry System" for the "quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples." Reagents used for testing biological samples are a core component of IVDs.
- Performance Studies: The summary of performance studies mentions "method comparison, stability, and imprecision experiments" comparing it to a predicate device (K942328 Behring Diagnostics N Latex RF). These types of studies are standard for demonstrating the performance and equivalence of IVDs.
- Predicate Device: The predicate device listed (K942328 Behring Diagnostics N Latex RF) is also an IVD, indicating that the device being described falls within the same regulatory category.
The key characteristic of an IVD is that it's used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Product codes
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Device Description
The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma 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 comparison, stability, and imprecision experiments that relate results obtained from the Behring N Latex RF Reagent to the IMMAGE System RF Reagent.
Method Comparison Study Results: IMMAGE RF Reagent vs. Behring N Latex RF Reagent. (Table is not in an extractable format)
Stability Study Results:
IMMAGE RF: 24 months shelf-life; 14 day open container; 14 day calibration
Estimated Within-Run Imprecision:
IMMAGE System RF Reagent
Level 1: Mean 124 IU/mL, SD 2.5 IU/mL, %CV 2.1, Number of Results 80
Level 2: Mean 299 IU/mL, SD 4.5 IU/mL, %CV 1.5, Number of Results 80
Level 3: Mean 637 IU/mL, SD 12.4 IU/mL, %CV 1.9, Number of Results 80
Key Metrics
%CV for within-run imprecision: Level 1 (2.1%), Level 2 (1.5%), Level 3 (1.9%).
Predicate Device(s)
Behring Diagnostics N Latex RF, K942328
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
BECKMAN
K96 3048
Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) 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:
05 Aug-1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent
3.2 Classification Names
Rheumatoid factor immunological test system(21 CFR 866.5775)
4.0 Predicate Device(s):
Behring Diagnostics N Latex RF, K942328
- 5.0 Description:
The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples.
6.0 Intended Use:
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Summary of Safety & Effectiveness
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 | ||
| RF Reagent | Intended use | Same as Behring |
| N Latex RF | ||
| IMMAGE System | ||
| RF Reagent | Nephelometric methodology | Same as Behring |
| N Latex RF | ||
| IMMAGE System | ||
| RF Reagent | Latex particle technology - | Same as Behring |
| N Latex RF | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| RF Reagent | Form of reagent | IMMAGE RF is a liquid stable |
| reagent, while Behring | ||
| N Latex RF is lyophilized. | ||
| IMMAGE System | ||
| RF Reagent | Stability | IMMAGE RF reagent is |
| stable for 14 days once | ||
| opened, properly stored, | ||
| while Behring N Latex RF | ||
| reagent is stable for one | ||
| week following reconstitution |
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) 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 comparison, stability, and imprecision experiments that relate results obtained from the Behring N Latex RF Reagent to the IMMAGE System RF Reagent.
Method Comparison Study Results IMMAGE RF Reagent vs. Behring N Latex RF Reagent
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Stability Study Results
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| Reagent | Product Claim |
|---|---|
| IMMAGE RF | 24 months shelf-life |
| 14 day open container | |
| 14 day calibration |
Estimated Within-Run Imprecision
| MATERIAL | MEAN
(IU/mL) | SD
(IU/mL) | %CV | Number of
Results |
|----------|--------------------------|---------------|-----|----------------------|
| | IMMAGE System RF Reagent | | | |
| Level 1 | 124 | 2.5 | 2.1 | 80 |
| Level 2 | 299 | 4.5 | 1.5 | 80 |
| Level 3 | 637 | 12.4 | 1.9 | 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.