(79 days)
Not Found
No
The device description and performance studies focus on traditional immunoassay techniques (turbidimetry and nephelometry) and do not mention any AI or ML components for data analysis or interpretation.
No
This device is for in vitro diagnostic use, intended for quantitative determination of cystatin C to aid in diagnosis and treatment of renal diseases, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases." This indicates its purpose in aiding medical diagnosis.
No
The device description clearly outlines physical components (immunoparticles, control set, calibrator) which are reagents used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use" in the "Intended Use / Indications for Use" section.
- Intended Use: The device is intended for the quantitative determination of cystatin C in human serum, heparinized plasma, and EDTA plasma. These are biological samples taken from the human body.
- Diagnostic Purpose: The measurements are used "as an aid in the diagnosis and treatment of renal diseases." This clearly indicates a diagnostic purpose.
- Components: The description includes components like immunoparticles, controls, and calibrators, which are typical reagents and materials used in in vitro diagnostic assays.
- Methodology: The method described (turbidimetry and nephelometry) is a common technique used in clinical laboratories for quantitative measurements of substances in biological fluids.
- Professional Use: The indication "For Professional Use Only" aligns with the use of IVDs in a clinical laboratory setting by trained professionals.
N/A
Intended Use / Indications for Use
Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
The Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
Product codes (comma separated list FDA assigned to the subject device)
NDY, JJX, JIT
Device Description
Cystatin C Immunoparticles are purified immunoglobulin fraction of rabbit antiserum directed against cystatin C covalently coupled to uniform polystyrene particles. The Cystatin C Immunoparticles are provided as a suspension preserved with 15 mmol/L sodium azide and are supplied ready for use. Recombinant human cystatin C produced in E. coli was used as an immunogen for raising the antibody coupled to the polystyrene particles.
In the DakoCytomation Cystatin C Assay, human serum or plasma is mixed with the Cystatin C Immunoparticles. The resulting immune complexes are measured by turbidimetry or nephelometry. The generated signal is correlated with the concentration of cystatin C in the sample. By interpolation on a standard curve, the concentration of cystatin C in the sample is calculated.
Cystatin C Control Set is a bi-level control. The controls are liquid pools of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Control Set is supplied ready for use.
The cystatin C value assignment has been carried out by turbidimetry using the DakoCytomation Cystatin C Calibrator, code No. X 0974, as reference.
Cystatin C Calibrator is a liquid pool of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Calibrator is supplied ready for use.
The cystatin C value assignment has been carried out by turbidimetry using a precise transfer protocol ensuring traceability to a pure recombinant human cystatin C reference preparation, where the cystatin C concentration was established by dry mass determination.
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
For In Vitro Diagnostic Use. For Professional Use Only.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics and data presented in support of the Cystatin C Immunoparticles together with Cystatin C Control Set and Cystatin C Calibrator include precision, accuracy, linearity, sensitivity, specificity, security ranges, interferences and stability testing. Assay results obtained with various commercially available turbidimeters and IMMAGE® Immunochemistry System (nephelometer) were analyzed and found to be comparable.
A comparison of performance between the DakoCytomation Cystatin C Immunoparticles, Cystatin C Control Set and Cystatin C Calibrator with the Dade Behring, Inc. N Latex Cystatin C Test Kit (K003503) and N Protein Standard UY (K003501) demonstrated substantial equivalence. Additionally, a comparison of performance between the DakoCytomation Cystatin C Assay, and the Roche Diagnostics Corp. Creatinine Plus assay (K953239) demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'K' inside of an oval shape. To the right of the logo is the text 'Design & Development'. The text is in a simple sans-serif font and appears to be slightly blurred, possibly due to the image quality or resolution.
SEP - 3 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Assigned 510(k) number
K04 627 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
Submitter's Information
Name: Address:
Phone: Fax Contact person: Date of preparation:
Device Name
Trade Name: Common/Usual name: Classification name:
Trade Name: Common/Usual name: Classification name:
DakoCytomation Denmark A/S Produktionsvej 42 DK-2600 Glostrup Denmark + 45 44 85 95 00 + 45 88 30 59 98 Dana Olsen, Requiatory Affairs June 10, 2004
Cystatin C Immunoparticles (code No. LX 002) Cystatin C Reagent Test, Cystatin C (21 CFR - 862.1225)
Cystatin C Control Set (code No. X 0973) Controls Single (Specified) Analyte Controls (Assayed and Unassayed) (21 CFR 862.1660)
Cystatin C Calibrator (code No. X 0974) Trade Name: Common/Usual name: Calibrator Classification name: Calibrator, Secondary (21 CFR 862.1150)
Predicate Devices
For Cystatin C Immunoparticles:
N Latex Cystatin C Test Kit, Dade Behring, Inc. (K003503) Creatinine Plus, Roche Diagnostics Corp. (K953239)
For Cystatin C Control Set: N Cystatin C Control, Dade Behring, Inc. (K003503)
For Cystatin C Calibrator: N Protein Standard UY, Dade Behring, Inc. (K003501)
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S
1
Device Description
Cystatin C Immunoparticles are purified immunoglobulin fraction of rabbit antiserum directed against cystatin C covalently coupled to uniform polystyrene particles. The Cystatin C Immunoparticles are provided as a suspension preserved with 15 mmol/L sodium azide and are supplied ready for use. Recombinant human cystatin C produced in E. coli was used as an immunogen for raising the antibody coupled to the polystyrene particles.
In the DakoCytomation Cystatin C Assay, human serum or plasma is mixed with the Cystatin C Immunoparticles. The resulting immune complexes are measured by turbidimetry or nephelometry. The generated signal is correlated with the concentration of cystatin C in the sample. By interpolation on a standard curve, the concentration of cystatin C in the sample is calculated.
Cystatin C Control Set is a bi-level control. The controls are liquid pools of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Control Set is supplied ready for use.
The cystatin C value assignment has been carried out by turbidimetry using the DakoCytomation Cystatin C Calibrator, code No. X 0974, as reference.
Cystatin C Calibrator is a liquid pool of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Calibrator is supplied ready for use.
The cystatin C value assignment has been carried out by turbidimetry using a precise transfer protocol ensuring traceability to a pure recombinant human cystatin C reference preparation, where the cystatin C concentration was established by dry mass determination.
Intended Use
For In Vitro Diagnostic Use. For Professional Use Only.
Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases
Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
The Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark AJS
2
Substantial Equivalence Comparison
The DakoCytomation Cystatin C Immunoparticles are substantially equivalent to the Dade Behring, Inc., N Latex Cystatin C Test Kit (K003503) with respect to indications for use, device design, materials and operational principles. The basic differences between the new device and the Dade Behring predicate device is the instruments used for testing. The DakoCytomation device can be used on commercially available turbidimetry and nephelometry analyzers, while the Dade Behring, Inc. product is applicable only on the Dade Behring, Inc. Nephelometer Systems. The DakoCytomation Cystatin C Immunoparticles are also claimed substantially equivalent to the Roche Diagnostics Corp. Creatinine Plus (K953239) in the intended use and results obtained. The difference in technology does not introduce new issues of safety and effectiveness.
The DakoCytomation Cystatin C Control Set is substantially equivalent to the Dade Behring N Cystatin C Control (K003503), with regard to the technological characteristics and in terms of the intended use.
The DakoCytomation Cystatin C Calibrator is substantially equivalent to the Dade Behring N Protein Standard UY (K003501), with regard to the technological characteristics and in terms of the intended use.
Performance Characteristics and Data
Performance characteristics and data presented in support of the Cystatin C Immunoparticles together with Cystatin C Control Set and Cystatin C Calibrator include precision, accuracy, linearity, sensitivity, specificity, security ranges, interferences and stability testing. Assay results obtained with various commercially available turbidimeters and IMMAGE® Immunochemistry System (nephelometer) were analyzed and found to be comparable.
A comparison of performance between the DakoCytomation Cystatin C Immunoparticles, Cystatin C Control Set and Cystatin C Calibrator with the Dade Behring, Inc. N Latex Cystatin C Test Kit (K003503) and N Protein Standard UY (K003501) demonstrated substantial equivalence. Additionally, a comparison of performance between the DakoCytomation Cystatin C Assay, and the Roche Diagnostics Corp. Creatinine Plus assay (K953239) demonstrated substantial equivalence.
Substantial Equivalence
Based on the information provided in this premarket notification, DakoCytomation concludes that the new devices, Cystatin C Immunoparticles, Cystatin C Control Set and Cystatin C Calibrator, are safe, effective and substantially equivalent to the Dade Behring predicate devices N Latex Cystatin C Test Kit (K003503), N Cystatin C Control (K003503) and N Protein Standard UY (K003501) respectively, with regard to the indications for use, device design, materials and operational principles. Additionally, the Cystatin C Immunoparticles are substantially equivalent to Roche Diagnostics Corp. Creatinine Plus (K953239) with regard to the intended use.
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 3 2004
Ms. Dana Olsen Regulatory Affairs DakoCytomation Denmark A/S Produktionsvej 42 DK-2600 Glostrup Denmark
Re:
Trade/Device Name: Cystatin C Immunoparticles Cystatin C Control Set Cystatin C Calibrator Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test system
Regulatory Class: Class II Product Code: NDY, JJX, JIT Dated: June 10, 2004 Received: June 16, 2004
Dear Ms. Olsen:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Jean M. Cooper MS DVM
Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number K041627
Indications for Use
Device Name: Cystatin C Immunoparticles
Indications for Use:
For In Vitro Diagnostic Use. For Professional Use Only.
Cystatin C Immunoparticles are intended for the quantitative defermiof cystation of cystatin C in human serum, heparinized plasma and EDTA nation of of overbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benem
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041627
Page 1 of 3
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S
6
510(k) Number K04 1627
Indications for Use
Device Name: Cystatin C Control Set
Indications for Use:
For In Vitro Diagnostic Use. For Professional Use Only.
Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K041627
Page 2 of 3
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S
7
K641627 510(k) Number
Indications for Use
Device Name: Cystatin C Calibrator
Indications for Use:
For In Vitro Diagnostic Use. For Professional Use Only.
Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson
inn Sien-Oft
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K041627
Page 3 of 3
Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S