(89 days)
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No
The summary describes a standard immunochemistry system for quantitative determination of CRP, focusing on reagent performance, stability, and imprecision. There are no mentions of AI, ML, or related concepts.
No
The device is an in vitro diagnostic intended for quantitative determination of C-reactive protein, not for treating any condition.
Yes
The device is intended for the quantitative determination of human C-reactive protein concentrations, which is a measurement used in diagnosis, indicating it is a diagnostic device.
No
The device is described as a reagent and calibration material for an immunochemistry system, which are physical components used in laboratory testing, 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 C-reactive protein concentrations in human serum and plasma samples." This is a classic description of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health status.
- Device Description: The device description reiterates the intended use, confirming it's for analyzing human serum and plasma samples.
- Anatomical Site: The "Not Applicable (In vitro diagnostic)" entry under Anatomical Site further confirms its IVD nature. IVDs don't directly interact with a specific anatomical site on the patient's body.
- Performance Studies: The performance studies focus on metrics relevant to IVDs, such as method comparison (comparing results to a predicate device), stability (shelf-life, open container, calibration), and imprecision (within-run variability). These are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Behring N Latex CRP) is also characteristic of the regulatory pathway for IVDs, where new devices are often compared to existing, legally marketed devices.
The information provided clearly indicates that this device is designed to perform a diagnostic test on biological samples outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein 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 (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 Behring N Latex CRP Reagent to the IMMAGE CRP Reagent.
Method Comparison Study Results: Not legible in provided text.
Stability Study Results:
IMMAGE CRP Reagent claims a 24 month shelf-life, 14 day open container stability, and 14 day calibration stability.
Estimated Within-Run Imprecision:
Level 1: MEAN (mg/dL) 1.65, SD (mg/dL) 0.134, %CV 8.1, Number of Results 80
Level 2: MEAN (mg/dL) 5.41, SD (mg/dL) 0.165, %CV 3.1, Number of Results 80
Level 3: MEAN (mg/dL) 12.6, SD (mg/dL) 0.22, %CV 1.8, Number of Results 80
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.
Behring N Latex CRP
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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§ 866.5270 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
Revised
10/4/96
Inc: Dated
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reag
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:
06 Aug-1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent
3.2 Classification Names
C-reactive protein immunological test system(21 CFR 866.5270)
4.0 Predicate Device(s):
Behring N Latex CRP
5.0 Description:
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples.
6.0 Intended Use:
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
1
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 | ||
| (CRP) Reagent | Intended Use | Same as Behring |
| N Latex CRP | ||
| IMMAGE System | ||
| (CRP) Reagent | Nephelometric methodology | Same as Behring |
| N Latex CRP | ||
| IMMAGE System | ||
| (CRP) Reagent | Use of Latex particle technology | Same as Behring |
| N Latex CRP | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| (CRP) Reagent | Form of reagent | the IMMAGE CRP is liquid |
| stable while Behring N Latex | ||
| CRP reagent is lyophilized | ||
| IMMAGE System | ||
| (CRP) Reagent | Antibody source | IMMAGE CRP uses goat |
| while Behring N Latex CRP | ||
| uses rabbit. | ||
| IMMAGE System | ||
| (CRP) Reagent | Stability | IMMAGE CRP is stable for 14 |
| days once opened, properly | ||
| stored while Behring N Latex | ||
| CRP reagent is stable for one | ||
| week following reconstitution,. |
2
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 CRP Reagent to the IMMAGE CRP Reagent.
Method Comparison Study Results IMMAGE CRP Reagent vs. Behring N Latex CRP Reagent
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Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE CRP | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Within-Run Imprecision
| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
|---|---|---|---|---|
| CRP Reagent | ||||
| Level 1 | 1.65 | 0.134 | 8.1 | 80 |
| Level 2 | 5.41 | 0.165 | 3.1 | 80 |
| Level 3 | 12.6 | 0.22 | 1.8 | 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.