(49 days)
K 944288
K 944288
No
The description details a standard ELISA assay, a well-established laboratory technique that does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is designed for the measurement of C-reactive protein to aid in diagnosing inflammatory conditions, not for treating them.
Yes
Explanation: The device is designed for the "measurement of C-reactive protein in human serum and plasma" to "measur[e] the acute phase responses in humans to infection, tissue damage and various inflammatory conditions," which are diagnostic purposes.
No
The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test method involving physical reagents and a microwell plate, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is designed for the "measurement of C-reactive protein in human serum and plasma." This indicates that the device is used to examine specimens derived from the human body.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative detection of C-Reactive Protein (CRP) in human serum and plasma." This describes a laboratory test performed on biological samples.
- Performance Studies: The performance studies describe testing conducted on "human serum samples" and "plasma samples," further confirming the use of human biological specimens.
- Predicate Device: The predicate device listed is also an "EIA method" kit for C-Reactive Protein, which is a common type of IVD.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or inborn abnormality, or to determine the safety or suitability of a transfusion or transplantation, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
This kit has been designed for the measurement of C-reactive protein in human serum and plasma. When used according to instructions, the kit is useful in measuring the acute phase responses in humans to infection, tissue damage and various inflammatory conditions.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative detection of C-Reactive Protein (CRP) in human serum and plasma.
The ELISA methodology is commonly used for serological evaluations. Antibodies to CRP have been attached to the inner surfaces of the microwell plate. During the initial incubation step, CRP in patient serum binds specifically to the immobilized antibody and remains in place after a wash step.
A second antibody, which is conjugated to the enzyme horseradish peroxidase, reacts with CRP bound in the first step. In the wells where the second antibody remains bound, the enzyme catalyzes a color change in the substrate, tetramethylbenzidine (TMB). After the reaction is stopped, the color is read in an EIA plate reader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Comparison Testing: Eighteen human serum samples with CRP concentrations ranging from 1 to 100 ug/mL were evaluated concurrently with both the proposed device and the predicate device to demonstrate the equivalence of the CRP concentrations estimated with each of the kits in accordance with the instructions in their respective package inserts. Analysis of the results of this study indicated that a linear relationship with a high degree of correlation exists between the estimated CRP concentrations for assayed serum samples as evidenced by an estimated regression slope of +1.0 and a correlation coefficient of > 0.90.
Assay performance with Serum and Plasma: Two sets of plasma samples of 41 samples each from apparently healthy donors were selected. Half of the volume of each sample was converted to serum by recalcification using a standard Ca2+ /thrombin methodology. All of the plasma and converted serum samples were assayed for CRP concentrations with the Hemagen CRP 150 Kit in accordance with the Draft package insert. The results of the evaluation with proposed device indicate that it can provide accurate estimates of CRP concentrations in both human serum and plasma.
Interfering Substances: Lipemic, hemolytic, and iteric samples were evaluated following NCCLS Proposed Guideline, "Interference Testing in Cinical Chemistry" Document EP7-P ISSN 0273-3099. Samples with hemgall on concentrations of
§ 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
MAR 1 2 1996
510(k) Summary Hemagen ® CRP 150 Kit
Submitter's Name/Contact Person
Joseph M. Califano, Manager, Regulatory Affairs
Address
1
..............................................................................................................................................................................
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
| Phone: | (617) 890-3766 |
|---|---|
| Fax: | (617) 890-3748 |
Date Prepared
19 January 1996
2 Device Names
Trade Name: Hemagen ® CRP 150 Kit Common Name: C-Reactive Protein Assay (EIA method) C-reactive protein immunological test system Classification Name: (per 21 CFR 866.5270)
3 Predicate Device
Hemagen ® C-Reactive Protein Kit (EIA method) Reference Docket No: K 944288
1
510/k) Summary Hemagen ® CRP 150 Kit
4 Description of Device
An enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative detection of C-Reactive Protein (CRP) in human serum and plasma.
The ELISA methodology is commonly used for serological evaluations. Antibodies to CRP have been attached to the inner surfaces of the microwell plate. During the initial incubation step, CRP in patient serum binds specifically to the immobilized antibody and remains in place after a wash step.
A second antibody, which is conjugated to the enzyme horseradish peroxidase, reacts with CRP bound in the first step. In the wells where the second antibody remains bound, the enzyme catalyzes a color change in the substrate, tetramethylbenzidine (TMB). After the reaction is stopped, the color is read in an EIA plate reader.
5 Intended Use of Device
This kit has been designed for the measurement of C-reactive protein in human serum and plasma. When used according to instructions, the kit is useful in measuring the acute phase responses in humans to infection, tissue damage and various inflammatory conditions.
6.(A) Technological Characteristics
The Hemagen CRP 150 Kit is an enzyme-linked immunosorbent assay with the following features:
- i. The assay's detection range is 1ug/mL to 50 ug/mL of CRP.
- ii. A positive control.
- iii. A set of CRP standards.
- iv. The HRP conjugate is supplied as a liquid.
The predicate device is also an enzyme-linked immunosorbent assay.
2
510(k) Summary Hemagen ® CRP 150 Kit
6.(B) Performance Data
. Verification of CRP Standards
The CRP Standards have been compared to the W.H.O International Standard for Human C-Reactive Protein (1st International Standard, Code 85/506). A study was conducted to demonstrate the high degree of correlation that exists between the Kit standards and the W.H.O. Standard.
11. Comparison Testing
Eighteen human serum* samples with CRP concentrations ranging from 1 to 100 ug/mL were evaluated concurrently with both the proposed device and the predicate device to demonstrate the equivalence of the CRP concentrations estimated with each of the kits in accordance with the instructions in their respective package inserts.
(*In the submission for the predicate device, the EIA methodology was shown to be substantially equivalent to a latex aggluntination method by concurrent comparison with 166 human serum samples.}
Analysis of the results of this study indicated that a linear relationship with a high degree of correlation exists between the estimated CRP concentrations for assayed serum samples as evidenced by an estimated regression slope of +1.0 and a correlation coefficient of > 0.90.
III. Assay performance with Serum and Plasma
Two sets of plasma samples of 41 samples each from apparently healthy donors were selected. Half of the volume of each sample was converted to serum by recalcification using a standard Ca2+ /thrombin methodology.
All of the plasma and converted serum samples were assayed for CRP concentrations with the Hemagen CRP 150 Kit in accordance with the Draft package insert.
The results of the evaluation with proposed device indicate that it can provide accurate estimates of CRP concentrations in both human serum and plasma.
3
510(k) Summary Hemagen ® CRP 150 Kit
IV. Interfering Substances
Lipemic, hemolytic, and iteric samples were evaluated with the Hemagen CRP 150 Kit following NCCLS Proposed Guideline, "Interference Testing in Cinical Chemistry" Document EP7-P ISSN 0273-3099. Samples with hemgall on concentrations of ≤ 500 mg/dL, lipid concentrations of ≤ 3,000 mg/dL, and bilirubin concentrations of 20 mg/dL did not significantly affect the assay results.
V. Precision Studies
Between-run reproducibility {Inter Assay}
Eight serum samples were assayed five times each, twice a day, on five different days (a total of 50 readings per sample). The results are as follows:
| Sample | Mean µg/mL | Std. Deviation | C.V. |
|---|---|---|---|
| 1 | 1.4 | 0.2 | 12 |
| 2 | 1.7 | 0.2 | 11 |
| 3 | 4.0 | 0.3 | 7 |
| 4 | 10.0 | 0.8 | 8 |
| 5 | 23.6 | 1.9 | 8 |
| 6 | 24.9 | 1.9 | 8 |
| 7 | 32.5 | 2.2 | 7 |
| 8 | 30.2 | 1.6 | 5 |
Within-run reproducibility {Intra Assay}
Eight serum samples were assayed 19 consecutive times in single runs. The results are as follows:
| Sample | Mean µg/mL | Std. Deviation | C.V. |
|---|---|---|---|
| 1 | 1.0 | 0.2 | 17 |
| 2 | 1.1 | 0.3 | 25 |
| 3 | 4.0 | 0.7 | 17 |
| 4 | 10.6 | 1.6 | 15 |
| 5 | 22.8 | 1.1 | 5 |
| 6 | 25.9 | 1.5 | 6 |
| 7 | 31.9 | 1.9 | 6 |
| 8 | 28.1 | 3.2 | 11 |
Conclusions
7
The results of the comparative studies support the claim that the Hemagen kit is a safe and effective in vitro diagnostic test and is substantially equivalent to the predicate device.