Who is the manufacturer of DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET?

Diazyme Laboratories filed the 510(k) submission for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557).

What is the FDA product code for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET?

DCK. It is classified under 21 CFR 866.5270 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET?

Roche TINA-QUANT CRP (LATEX) HS TEST SYSTEM (K042485).

Who can help prepare an FDA 510(k) submission like DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET

K103557 · Diazyme Laboratories · DCK · Apr 27, 2011 · Immunology

Device Facts

Record ID	K103557
Device Name	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
Applicant	Diazyme Laboratories
Product Code	DCK · Immunology
Decision Date	Apr 27, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended 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.

Device Story

Latex-enhanced immunoturbidimetric assay; measures CRP in human serum/plasma. Input: patient sample mixed with anti-CRP antibody-sensitized latex particles. Principle: antigen-antibody reaction causes agglutination; detected via absorbance change at 570 nm. Output: CRP concentration determined by interpolation from calibration curve. Used in clinical laboratories on automated chemistry analyzers; operated by laboratory personnel. Results assist clinicians in evaluating inflammatory states, infections, and tissue injury. Benefits: provides quantitative diagnostic marker for monitoring patient response to therapy/surgery.

Clinical Evidence

Bench testing only. Method comparison study (n=57) vs. predicate showed correlation coefficient 0.99, slope 1.0133, intercept 0.0196. Precision study (CLSI EP5-A) over 20 days showed within-run CV 0.7-4.0% and total precision 1.4-4.2%. Interference testing confirmed <10% deviation for triglycerides, ascorbic acid, bilirubin, hemoglobin, and rheumatoid factor.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: Tris-buffer (pH/concentration not specified) and latex particles (<0.5%) coated with goat anti-human CRP, both with 0.09% sodium azide. Detection: 570 nm absorbance. Form factor: liquid-stable reagents, calibrators, and controls. Connectivity: compatible with automated clinical chemistry analyzers.

Indications for Use

Indicated for in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma to aid in detection and evaluation of inflammatory disorders, infection, and tissue injury. For professional use on automated clinical chemistry analyzers.

Regulatory Classification

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.

Predicate Devices

Roche TINA-QUANT CRP (LATEX) HS TEST SYSTEM (K042485)

Reference Devices

Dade-Behring N hsCRP
C.f.a.s. Proteins (K011226)
Roche CRP T Control N (K982087)
Precinorm Protein Control (K871027)

Related Devices

K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 · Instrumentation Laboratory CO · Dec 19, 2003
K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT · Denka Seiken Co., Ltd. · Jun 2, 2003
K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS · Instrumentation Laboratory CO · Dec 23, 2002
K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS · Siemens Healthcare Diagnostics, Inc. · Jul 29, 2008
K011958 — CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT · Denka Seiken'S · Dec 4, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ K103557 # 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 (<0.5%) coated with goat anti-human CRP with 0.09% so- dium azide, ready to use. | | Calibrators Ready to use liquid calibrators containing C- reactive protein | Calibrators Ready to use liquid calibrators prepared from human serum, purified human C-reactive protein, and 0.09% sodium azide | | Calibrator set 1 x 1.0 mL Calibrator 0 1 x 1.0 mL Calibrator 1 1 x 1.0 mL Calibrator 2 1 x 1.0 mL Calibrator 3 1 x 1.0 mL Calibrator 4 1 x 1.0 mL Calibrator 5 | Calibrator set 1 x 1.0 mL Calibrator 1 1 x 1.0 mL Calibrator 2 1 x 1.0 mL Calibrator 3 1 x 1.0 mL Calibrator 4 | | Control Set serum based 3 x 1.0mL Control 1 3 x 1.0mL Control 2 | Control Set serum based 1 x 3.0mL Control 1 1 x 3.0mL Control 2 | ### Table 1 Summary of Assay Kit Components {3}------------------------------------------------ Comparison of new device to predicate: The charts below identify similarities and differences between the predicate device and the Diazyme hsCRP Assay. # Indications for Use | Indications for Use | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Roche Tina-Quant CRP k042485 | Diazyme hsCRP Assay | Equivalency | | The Tina-quant® CRP (Latex) High Sensi- tive Immmunoturbidimetric assay is for the 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 | {7}------------------------------------------------ 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). {8}------------------------------------------------ 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