(135 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring CRP and does not mention any AI/ML components or related concepts like training/test sets for algorithms.
No
This device is an in vitro diagnostic (IVD) device used to measure C-Reactive Protein, which helps in the evaluation and monitoring of certain conditions. It does not directly treat or alleviate a disease, but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device".
No
The device is an in vitro diagnostic assay intended to measure C-Reactive Protein in human serum, which is a chemical reagent and not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device intended to measure C-Reactive Protein in human serum."
The "Device Description" also reinforces this by stating: "This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems."
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems. Measurements of CRP are used in the evaluation and treatment of injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.
The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device into ded to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Imprecision (normal range)
ADVIA IMS:
Level (mg/L): 16.5, Total CV (%): 2.9
Level (mg/L): 31.7, Total CV (%): 2.1
Level (mg/L): 47.5, Total CV (%): 3.1
Dade/Behring BN100:
Level (mg/L): 10, Total CV(%):
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS High Sensitivity C-Reactive Protein (CRP) Method for ADVIA® IMS™
This summary of 510(k) safety and effectiveness information is being submitted in Fills Summary of 51 (1) Sales July 1998) and the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K012337
1. Intended Use
This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems. Measurements of CRP are used in the evaluation and treatment of injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.
Predicate Device 2.
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Dade/Behring N High | ||
| Sensitivity CRP, | ||
| K991385 | OQIY 21 | OQIK |
Device / Method 3.
| Product Name | Reagent BAN | Calibrator
BAN |
|---------------|--------------------------------------------|-------------------|
| ADVIA IMS CRP | 03987289 (100 test)
02136137 (250 test) | 02537697 |
A. Imprecision (normal range)
| ADVIA IMS | |
|---|---|
| Level (mg/L) | Total CV (%) |
| 16.5 | 2.9 |
| 31.7 | 2.1 |
| 47.5 | 3.1 |
| Dade/Behring | |
|---|---|
| BN100 | |
| Level | |
| (mg/L) | Total |
| CV(%) | |
| 10 |