(149 days)
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No
The summary describes a reagent and calibrator for a standard immunochemistry system using rate nephelometry, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for the quantitative determination of human ceruloplasmin, a diagnostic rather than therapeutic purpose.
Yes
The device is intended for the quantitative determination of human ceruloplasmin, which is a measurement used for diagnostic purposes.
No
The device description clearly states it is a "Reagent" intended for use with a specific "Immunochemistry System," indicating it is a chemical substance used in a laboratory instrument, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative determination of human ceruloplasmin by rate nephelometry." This describes a test performed in vitro (outside the body) on a human sample (serum) to provide diagnostic information (quantitative determination of ceruloplasmin).
- Device Description: The "Device Description" further clarifies its use in determining ceruloplasmin concentrations in "human serum samples."
- Performance Studies: The "Summary of Performance Studies" describes method comparison, stability, and imprecision experiments, which are standard evaluations for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a "Predicate Device" (K791339; Beckman Ceruloplasmin (CER)) is common in regulatory submissions for IVDs, where a new device is compared to an already cleared device.
All these elements strongly indicate that this device is designed and intended for use as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMMAGE Immunochemistry System CER Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of ceruloplasmin concentrations in human serum samples 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 comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results: IMMAGE CER Reagent vs. Beckman Array Systems CER Reagent for serum samples (n=104) resulted in a slope of 0.996, intercept of -2.43, and r of 0.995.
Estimated Imprecision:
Within Run precision for Serum Level 1 (n=80) was 13.6 mg/dL (mean), 0.42 mg/dL (SD), 3.1 % CV.
Within Run precision for Serum Level 2 (n=80) was 49.3 mg/dL (mean), 1.20 mg/dL (SD), 2.4 % CV.
Within Run precision for Serum Level 3 (n=80) was 88.0 mg/dL (mean), 2.72 mg/dL (SD), 3.1 % CV.
Total precision for Serum Level 1 (n=80) was 13.6 mg/dL (mean), 0.52 mg/dL (SD), 3.8 % CV.
Total precision for Serum Level 2 (n=80) was 49.3 mg/dL (mean), 1.74 mg/dL (SD), 3.5 % CV.
Total precision for Serum Level 3 (n=80) was 88.0 mg/dL (mean), 3.76 mg/dL (SD), 4.3 % CV.
Within Run precision for Low Serum Level 1 (n=30) was 1.4 mg/dL (mean), 0.08 mg/dL (SD), 5.8 % CV.
Within Run precision for Low Serum Level 2 (n=30) was 4.3 mg/dL (mean), 0.17 mg/dL (SD), 3.9 % CV.
Total precision for Low Serum Level 1 (n=30) was 1.4 mg/dL (mean), 0.09 mg/dL (SD), 6.6 % CV.
Total precision for Low Serum Level 2 (n=30) was 4.3 mg/dL (mean), 0.17 mg/dL (SD), 3.9 % CV.
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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§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(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 the limitations in § 866.9.
0
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent
APR
25
1997
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:
26 November 1996
Device Name(s): 3.0
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent
Classification Name 3.2
Ceruloplasmin immunological test system (21 CFR § 866.5210)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|--------------------------------------|--------------------------------|------------------------------|------------------|
| IMMAGE System
Ceruloplasmin (CER) | Beckman Ceruloplasmin
(CER) | Beckman Instruments,
Inc. | K791339 |
5.0 Description:
The IMMAGE Immunochemistry System CER Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of ceruloplasmin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
Beckman Instruments, Inc.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent Summary of Safety & Effectiveness
6.0 Intended Use:
The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.
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 | ||
| CER Reagent | Analytic Range | Same as Beckman |
| Ceruloplasmin reagent | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| CER Reagent | Buffer/Reagent volumes | IMMAGE System uses half of |
| the volumes than are utilized | ||
| by the Array System for CER. | ||
| Antibody concentration | IMMAGE CER has a higher | |
| antibody concentration than | ||
| the Beckman Ceruloplasmin | ||
| reagent |
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 comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results IMMAGE Ceruloplasmin (CER) Reagent
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| CER | ||||||
| Reagent | serum | 0.996 | -2.43 | 0.995 | 104 | Beckman Array Systems |
| CER Reagent |
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent Summary of Safety & Effectiveness
Stability Study Results
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Estimated Imprecision
| TYPE
OF
PRECISION | SAMPLE | Data
Points | Test
Mean
Value
(mg/dL) | SD
(mg/dL) | % CV |
|-------------------------|---------------|----------------|----------------------------------|---------------|------|
| Within Run | Serum Level 1 | 80 | 13.6 | 0.42 | 3.1 |
| Within Run | Serum Level 2 | 80 | 49.3 | 1.20 | 2.4 |
| Within Run | Serum Level 3 | 80 | 88.0 | 2.72 | 3.1 |
| Total | Serum Level 1 | 80 | 13.6 | 0.52 | 3.8 |
| Total | Serum Level 2 | 80 | 49.3 | 1.74 | 3.5 |
| Total | Serum Level 3 | 80 | 88.0 | 3.76 | 4.3 |
| TYPE
OF
PRECISION | SAMPLE | Data
Points | Test
Mean
Value
(mg/dL) | SD
(mg/dL) | % CV |
|-------------------------|-------------------|----------------|----------------------------------|---------------|------|
| Within Run | Low Serum Level 1 | 30 | 1.4 | 0.08 | 5.8 |
| | Low Serum Level 2 | 30 | 4.3 | 0.17 | 3.9 |
| Total | Low Serum Level 1 | 30 | 1.4 | 0.09 | 6.6 |
| | Low Serum Level 2 | 30 | 4.3 | 0.17 | 3.9 |
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.