(146 days)
No
The device description and performance studies describe a standard immunoturbidimetric assay with interpolation from a calibration curve. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision support.
No
The device is an in vitro diagnostic assay used for the quantitative determination of C-reactive protein (CRP) to detect and evaluate inflammatory disorders; it does not provide therapy or treatment.
Yes
The device is described as an "in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma" and states that "Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only." This clearly indicates its purpose is to aid in diagnosing medical conditions by providing quantitative data from patient samples.
No
The device is an in vitro diagnostic assay kit, which includes reagents and calibrators/controls, and is used on automated clinical chemistry analyzers. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use only" multiple times for the assay, calibrator set, and control set. It also describes the intended use as the "in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma". This clearly indicates the device is used to test samples taken from the human body outside of the body.
- Device Description: The description details a laboratory-based assay (latex enhanced immunoturbidimetric assay) performed on automated clinical chemistry analyzers, which are typical settings for IVD testing.
- Intended User/Care Setting: It specifies use on "Automated clinical chemistry analyzers" and reiterates "For in vitro diagnostic use only".
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP assay Calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only.
The Diazyme hsCRP assay Control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIT, JJX
Device Description
Diazyme hsCRP assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
Diazyme hsCRP Assay calibrator set is intended for use with the Diazyme hsCRP Assay kit. Five calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.
Diazyme hsCRP Assay 3-point control set is intended for use with the Diazyme hsCRP Assay kit. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly.
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
Laboratory users
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)
Method Comparison Study Summary: Human serum samples were tested with the Diazyme hsCRP Assay and the obtained results were compared to the predicate method. A total of 57 samples (ranging from 0.19 to 18.97 mg/L of CRP) were tested in both assays. The above described accuracy study showed that the Diazyme hsCRP Assay results correlated well with predicate method with a correlation coefficient of 0.99 with a slope of 1.0133 and 0.0196 y intercept.
Precision Study Summary: The precision of the Diazyme hsCRP Assay was evaluated according to Clinical and Laboratory Standards Institute EP5-A guideline. In the study, three levels of serum based controls containing approximately 0.8, 1.6, and 8.7 mg/L of CRP, and a serum sample containing approximately 3.6 mg/L of CRP respectively was tested with 2 runs per day in duplicates over 20 working days. An additional serum sample containing approximately 15.6 mg/L of CRP was tested with 2 runs per day in duplicates over 5 days.
Within-Run Precision: Level 1 (N=80, Mean=0.85, SD=0.03, CV%=4.0%), Level 2 (N=80, Mean=1.75, SD=0.03, CV%=1.7%), Level 3 (N=80, Mean=8.62, SD=0.06, CV%=0.7%), Serum (N=80, Mean=3.62, SD=0.05, CV%=1.4%), Serum (N=20, Mean=15.56, SD=0.19, CV%=1.2%).
Total Precision: Level 1 (N=80, Mean=0.85, SD=0.04, CV%=4.2%), Level 2 (N=80, Mean=1.75, SD=0.05, CV%=2.6%), Level 3 (N=80, Mean=8.62, SD=0.12, CV%=1.4%), Serum (N=80, Mean=3.62, SD=0.09, CV%=2.4%), Serum (N=20, Mean=15.56, SD=0.24, CV%=1.6%).
Interference Study Summary: The following substances normally present in the blood produced less than 10% deviation when tested at levels equal to the concentrations listed below: Triglyceride (1000 mg/dL), Ascorbic Acid (176 mg/dL), Bilirubin (40 mg/dL), Bilirubin Conjugated (40 mg/dL), Hemoglobin (500 mg/dL), Rheumatoid Factor (400 IU/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.99 (Method Comparison Study), 0.996 (from predicate device performance comparison)
Slope: 1.0133 (Method Comparison Study), 1.06 (from predicate device performance comparison)
Intercept: 0.0196 (Method Comparison Study), -0.19 (from predicate device performance comparison)
Precision: CV% of 0.7% - 7.3%
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.
Roche TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485)
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.
C.f.a.s. Proteins K011226, Roche CRP T Control N K982087, Precinorm Protein Control K871027
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).
Not Found
§ 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
.
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Fax: 858-455-2120 | |
| Date the Summary was Prepared: | April 19, 2011 |
| Name of the Device | hsCRP Assay Kit |
| hsCRP Assay Calibrator Set | |
| hsCRP Assay Control Set | |
| Trade Name: | Diazyme hsCRP Assay Kit |
| Diazyme hsCRP Assay Calibrator Set | |
| Diazyme hsCRP Assay Control Set | |
| Common/Usual Name | CRP Assay |
| Device Classification Name | hsCRP Test System |
| Product code: | DCK (Cardiac C-Reactive Protein, Antigen, Antiserum, |
| and Control) | |
| JIT - Calibrator, Secondary | |
| JJX - Single (specified) Analyte Controls (Assayed and Unassayed) | |
| Panel: | Immunology (82) |
| Submission Type | 510k |
1
Regulation Number
21CFR 866.5270
Device Class
Class II
Predicate Device:
Roche TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
| Manufacturing Address | Diazyme Laboratories
12889 Gregg Court
Poway, CA 92121
USA |
|----------------------------|---------------------------------------------------------------------|
| Establishment Registration | 2032900 |
Description of the Device:
Clinical Significance
CRP (C-reactive protein) is an acute phase protein whose concentration is seen to increase as a result of the inflammatory process, most notably in response to pneumococcal (bacterial) infectious, histolytic disease and a variety of disease states. Originally discovered by Tillet et al. in 1930 in patient sera with acute infection. CRP has now come to be used as a marker or general diagnostic indicator of infections and inflammation, in addition to serving as a monitor of patient response to therapy and surgery. Furthermore, regular measurements of CRP in infants can be a useful aid in the early diagnosis of infectious disease.
Assav Principle
Diazyme hsCRP assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
Diazyme hsCRP Assay calibrator set is intended for use with the Diazyme hsCRP Assay kit. Five calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.
Diazyme hsCRP Assay 3-point control set is intended for use with the Diazyme hsCRP Assay kit. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly.
2
Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received.
Indications for Use:
The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP assay Calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only.
The Diazyme hsCRP assay Control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay |
|---|---|
| Reagent 1 | |
| buffer solution, ready to use | Reagent 1 |
| 100 mM Tris-buffer solution with 0.09% so- | |
| dium azide, ready to use | |
| Reagent 2 | |
| Suspension of anti-human CRP coated latex | |
| particles, ready to use | Reagent 2 |
| Suspension of latex particles (in vitro quantitative determination of C- | |
| reactive protein (CRP) in human serum and | |
| plasma on Roche automated clinical chem- | |
| istry analyzers. | The Diazyme high sensitivity C-reactive |
| protein (hsCRP) assay is for the in vitro | |
| quantitative determination of C-reactive | |
| protein (CRP) in human serum and plasma | |
| on automated clinical chemistry analyzers. | Same except |
| for cardiac | |
| claim with | |
| Roche | |
| Highly sensitive measurement of CRP is of | |
| use for the detection and evaluation of in- | |
| flammatory disorders and associated dis- | |
| eases, infection and tissue injury. Measure- | |
| ment of CRP may also be used as an aid in | |
| the assessment of the risk of future coronary | |
| heart disease. When used as an adjunct to | |
| other laboratory evaluation methods of | |
| acute coronary syndromes, it may also be an | |
| additional independent indicator of recur- | |
| rent event prognosis in patients with stable | |
| coronary disease or acute coronary syn- | |
| drome | Measurement of CRP is of use for the de- |
| tection and evaluation of inflammatory dis- | |
| orders and associated diseases, infection | |
| and tissue injury. For in vitro diagnostic use | |
| only. |
Principle
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| Particle-enhanced immunoturbidimetric as- | ||
| say | ||
| · Sample and addition of R1 (buffer) | ||
| · Addition of R2 (anti-CRP antibody-latex) | ||
| and start of reaction: | ||
| Anti-CRP antibodies coupled to latex mi- | ||
| croparticles react with antigen in the sample | ||
| to form an antigen/antibody complex. Fol- | ||
| lowing agglutination, this is measured tur- | ||
| bidimetrically. | Diazyme's CRP assay is based on a latex | |
| enhanced immunoturbidimetric assay. | ||
| When an antigen-antibody reaction occurs | ||
| between CRP in a sample and anti-CRP | ||
| which has been sensitized to latex particles, | ||
| agglutination results. This agglutination is | ||
| detected as an absorbance change (570 nm), | ||
| with the magnitude of the change being | ||
| proportional to the quantity of CRP in the | ||
| sample. The actual concentration is then de- | ||
| termined by the interpolation from a cali- | ||
| bration curve prepared from calibrators of | ||
| known concentration. | Same |
Test Objective
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| ------------------------------ | --------------------- | ------------- |
4
| For the in vitro quantitative determination of CRP in human serum or plasma. | For the in vitro quantitative determination of CRP in human serum or plasma. | Same |
|---|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- | ------ |
Type of Test
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| Quantitative | Quantitative | Same |
Specimen Type
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| Human serum or plasma. | Human serum or plasma. | Same |
Product Type
:
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| Assay reagent kit, calibrator kit, quality con-trol kit. | Assay reagent kit, calibrator kit, quality con-trol kit. | Same |
Performance
| Roche Tina-Quant CRP K042485 | Diazyme hsCRP Assay |
|---|---|
| Working Range: 0.1-20 mg/L CRP | Linear Range: 0.2-20 mg/L CRP |
| Precision: CV% of 0.43 - 5.7% | Precision: CV% of 0.7% - 7.3% |
| Accuracy (vs Dade-Behring N hsCRP): | Accuracy (vs. Roche Tina-Quant hsCRP): |
| Correlation Coefficient: 0.996 | |
| Slope/Intercept: y = 1.06/-0.19 | Correlation Coefficient: 0.99 |
| Slope/ y Intercept: y = 1.01/0.0196 |
Calibrator Comparison
| C.f.a.s. Proteins K011226 | Diazyme hsCRP Assay | Equivalency |
|---|---|---|
| Separately packaged lot specific calibrator | ||
| kit. Liquid stable. | Separately packaged lot specific calibrator | |
| kit. Liquid stable. | Same |
Control Comparison
| Control Comparison | ||
|---|---|---|
| Roche CRP T Control N K982087, Preci- | ||
| norm Protein Control K871027 | Diazyme hsCRP Assay | Equivalency |
| Separately packaged quality control kit | ||
| designed for specific assay. | Separately packaged quality control set | |
| designed for specific assay. | Same |
5
Performance Testing Summaries:
Method Comparison Study Summary
Human serum samples were tested with the Diazyme hsCRP Assay and the obtained results were compared to the predicate method. A total of 57 samples (ranging from 0.19 to 18.97 mg/L of CRP) were tested in both assays. The above described accuracy study showed that the Diazyme hsCRP Assay results correlated well with predicate method with a correlation coefficient of 0.99 with a slope of 1.0133 and 0.0196 y intercept.
| Serum Samples | |
|---|---|
| n | 57 |
| Slope | 1.0133 |
| Intercept | 0.0196 |
| Correlation coeffi- | 0.99 |
| Range of values | 0.19 to 18.97 mg/L of CRP |
Precision Study Summary
The precision of the Diazyme hsCRP Assay was evaluated according to Clinical and Laboratory Standards Institute EP5-A guideline. In the study, three levels of serum based controls containing approximately 0.8, 1.6, and 8.7 mg/L of CRP, and a serum sample containing approximately 3.6 mg/L of CRP respectively was tested with 2 runs per day in duplicates over 20 working days. An additional serum sample containing approximately 15.6 mg/L of CRP was tested with 2 runs per day in duplicates over 5 days. Results were calculated using the EP Evaluator software precision statistic template and summarized in the following table:
| Within-Run Precision | |||||
|---|---|---|---|---|---|
| Level 1: | Level 2: | Level 3: | Serum | Serum | |
| N | 80 | 80 | 80 | 80 | 20 |
| Mean | 0.85 | 1.75 | 8.62 | 3.62 | 15.56 |
| SD | 0.03 | 0.03 | 0.06 | 0.05 | 0.19 |
| CV% | 4.0% | 1.7% | 0.7% | 1.4% | 1.2% |
Within-Run Precision
Total Precision
| Level 1: | Level 2: | Level 3: | Serum | Serum | |
|---|---|---|---|---|---|
| N | 80 | 80 | 80 | 80 | 20 |
| Mean | 0.85 | 1.75 | 8.62 | 3.62 | 15.56 |
| SD | 0.04 | 0.05 | 0.12 | 0.09 | 0.24 |
| CV% | 4.2% | 2.6% | 1.4% | 2.4% | 1.6% |
Conclusion:
For three levels of CRP controls, 20-day reproducibility data showed that the Within-Run Precision was from 0.7 % to 4.0 % and the Total Precision was from 1.4 % to 4.2%. For one serum sample, 20-day reproducibility data showed that the Within-Run Precision was 1.4 % and the
6
Total Precision was 2.4 %. For one serum sample, 5-day reproducibility data showed that the Within-Run Precision was 1.2 % and the Total Precision was 1.6 %.
Interference Study Summary
The following substances normally present in the blood produced less than 10% deviation when tested at levels equal to the concentrations listed below:
| Interference | Concentration |
|---|---|
| Triglyceride | 1000 mg/dL |
| Ascorbic Acid | 176 mg/dL |
| Bilirubin | 40 mg/dL |
| Bilirubin Conjugated | 40 mg/dL |
| Hemoglobin | 500 mg/dL |
| Rheumatoid Factor | 400 IU/mL |
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Public Health Service
Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. Inside the circle is an emblem of an abstract eagle or bird-like figure, which is a common symbol associated with the department.
Diazyme Laboratories c/o Dr. Abhijit Datta Director, Technical Operations 12889 Gregg Court Poway, CA 92064
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 2 7 2011
K103557 Re:
Diazyme high sensitivity C-reactive protein (hsCRP) assay kit; Trade Name: Diazyme high sensitivity C-reactive protein (hsCRP) assay calibrator set; Diazyme high sensitivity C-reactive protein (hsCRP) assay control set Regulation Number: 21 CFR §866.5270 Regulation Name: C-reactive protein, Antigen, Antiserum and Control Regulatory Class: Class II Product Codes: DCK, JIT, JJX Dated: April 19, 2011 Received: April 20, 2011
Dear Dr. Datta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (If Known): K103557
Device Name: Diazyme high sensitivity C-reactive protein (hsCRP) assay kit, Diazyme high sensitivity C-reactive protein (hsCRP) assay calibrator set, Diazyme high sensitivity C-reactive protein (hsCRP) assay control set.
Indications for Use:
The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP assay calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only.
The Diazyme hsCRP assay control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103557