(66 days)
Reagents: For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. Calibrator: For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.
Genzymc Cystatin C assay reagent is based on the sol particle turbidimetric immunoassay principle. It contains colloidal gold particles coated with anticystatin C specific polyclonal antibodies. The reaction between the particles and any cystatin C in samples results in the formation of agglutinates and an associated change in absorbance signal. The change in absorbance signal is proportional to the amount of cystatin C in the sample. Cystatin C concentration in the sample is determined by comparison with a standard curve. Genzyme Cystatin C calibrators consist of a bovine serum albumin liquid matrix with assigned concentrations of cystatin C. The calibrators are preserved with sodium azide and are ready to use.
The provided text describes a 510(k) summary for a medical device called "Genzyme Cystatin C Reagent and Calibrator." It details the device's intended use, comparison to a predicate device, and performance characteristics to establish substantial equivalence. However, it does not explicitly define "acceptance criteria" in a quantitative manner as typically expected in a scientific study. Instead, it refers to "Performance characteristics" and states that these "support a determination of substantial equivalence."
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for parameters like sensitivity, specificity, or accuracy. Instead, it indicates that the device's performance was compared to a legally marketed predicate device (Dade Behring N Latex Cystatin C). The "acceptance" is implicitly tied to demonstrating "comparable performance and accuracy, good correlation, and substantial equivalence" to the predicate device.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Analytical Limits and Sensitivity | Testing performed; data "support a determination of substantial equivalence." |
| Within-run and Total Precision (over 20 days) | Testing performed; data "support a determination of substantial equivalence." |
| Linearity | Testing performed; data "support a determination of substantial equivalence." |
| Reportable Range | Testing performed; data "support a determination of substantial equivalence." |
| Stability | Testing performed; data "support a determination of substantial equivalence." |
| Analytical Specificity | Testing performed; data "support a determination of substantial equivalence." |
| Interfering Substances | Testing performed; data "support a determination of substantial equivalence." |
| Matrix Comparison | Testing performed; data "support a determination of substantial equivalence." |
| Reference Range | Testing performed; data "support a determination of substantial equivalence." |
| Method comparison studies with clinical specimens: | "demonstrate comparable performance and accuracy, good correlation, and substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Method comparison studies performed with clinical specimens demonstrate comparable performance and accuracy, good correlation, and substantial equivalence." However:
- Sample size: The exact sample size for the test set (clinical specimens) used in the method comparison studies is not provided.
- Data provenance: The country of origin of the data is not specified. It can be inferred that the samples are human serum, heparinized plasma, and EDTA plasma, but whether they are retrospective or prospective is not stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable or not provided for this device. The device is an in vitro diagnostic (IVD) assay that quantifies cystatin C directly. The "ground truth" for method comparison studies in IVDs typically relies on the performance of a meticulously validated reference method or the predicate device itself, not on expert consensus from radiologists or similar clinical experts.
4. Adjudication Method for the Test Set
Since the "ground truth" is likely established by a reference method or the predicate assay itself, an adjudication method (like 2+1, 3+1) involving human experts is not applicable or not described for this type of IVD performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for image-based diagnostic aids or interpretations where human readers are involved. This device is an automated in vitro diagnostic assay for quantitative measurement. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned in the document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Genzyme Cystatin C assay is designed as an automated, standalone diagnostic test. Its performance characteristics (precision, linearity, specificity, analytical sensitivity, etc.) are inherently "algorithm only" in the sense that the device directly measures the analyte without human interpretation loops at the point of result generation. The "method comparison studies" essentially serve as a standalone performance assessment against a predicate method.
However, the term "standalone study" often implies a comparison to a clinical outcome or gold standard in the absence of human interpretation. While the method comparison evaluates the device's inherent analytical performance, the document doesn't use the term "standalone study" in a way that suggests a separate evaluation against a clinical gold standard beyond comparing it to the predicate device.
7. Type of Ground Truth Used
The primary ground truth used for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Dade Behring N Latex Cystatin C). The method comparison studies compare the Genzyme Cystatin C assay with the results obtained from the predicate device on clinical specimens. There is no mention of pathology, outcomes data, or expert consensus in this context.
8. Sample Size for the Training Set
The document is a 510(k) summary for an IVD reagent and calibrator kit, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's underlying principle is a turbidimetric immunoassay, not a learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, the concept of a "training set" is not applicable to this device.
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MAY 15 2008
510(k) Summary of Safety and Effectiveness for Genzyme Cystatin C
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K080662
| 1. Manufacturer's Name, Address, Telephone, Contact, Date of Preparation | |
|---|---|
| Manufacturer: | Genzyme Corporation |
Genzyme Diagnostics 31 New York Avenue Framingham, MA 01701 Contact Information: Genzyme Corporation 31 New York Avenue Framingham, MA 01701 Attn: Eric Lawson Tel: 800.332.1042 March 6, 2008 Preparation date: 2. Device Name / Classification: Trade or Proprietary Name: Genzyme Cystatin C Reagent Genzyme Cystatin C Calibrator Test. Cystatin C Common or Usual Name: Calibrator for Cystatin C test
Classification Name:
Creatinine Test System Calibrator, Secondary
3. Identification of the Legally Marketed Device:
Dade Behring N Latex Cystatin C - K041878 Dade Behring N Protein Standard UY, calibrator - K003501
4. Device Description:
Genzymc Cystatin C assay reagent is based on the sol particle turbidimetric immunoassay principle. It contains colloidal gold particles coated with anticystatin C specific polyclonal antibodies. The reaction between the particles and any cystatin C in samples results in the formation of agglutinates and an associated change in absorbance signal. The change in absorbance signal is proportional to the amount of cystatin C in the sample. Cystatin C concentration in the sample is determined by comparison with a standard curve.
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Genzyme Cystatin C calibrators consist of a bovine serum albumin liquid matrix with assigned concentrations of cystatin C. The calibrators are preserved with sodium azide and are ready to use.
5. Device Intended Use:
Reagents:
The Genzyme Cystatin C assay reagent is an in vitro diagnostic test intended for the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use.
Calibrator:
Genzyme Cystatin C calibrator is an in vitro diagnostic product for the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Usc.
6. Medical device to which equivalence is claimed and comparison information:
The Genzyme Cystatin C diagnostic test is substantially equivalent to the Dade Behring, Inc. N Latex Cystatin C method (K041878) with respect to the indications for use, the analyte tested, device design, the type of antibody materials, and the gencral sample matrix. The basic differences between the new device and the predicate are the assay technology and the instruments used for testing. The Genzyme device is a turbidimetric immunoassay that can be used on commercially available clinical analyzers using light absorption detection systems; while, the Dade Behring test is an immunonephelometric assay applicable only on Dade Behring, Inc. Nephelometer Systems.
The Genzyme Cystatin C calibrator is substantially equivalent to the Dade Behring N Protein Standard UY calibrator (K003501) with regard to the technological characteristics and in terms of the intended use. The difference is that the Genzymc calibrator is provided as a set of six liquid solutions of assigned cystatin C concentration levels and is ready to use for calibration; while, the Dade Behring N Protein Standard UY is a single lyophilized concentration of cystatin C calibrator that is prepared to various levels in order to establish values for calibration.
7. Device Performance Characteristics:
Performance characteristics and data from nonclinical tests submitted in the premarket notification submission support a determination of substantial equivalence of the Genzyme Cystatin C devices with the Dade Behring predicate devices. This testing includes: analytical limits and sensitivity, within run and total precision testing over 20 days, linearity, reportable range, stability, analytical specificity, interfering substances, matrix comparison, and reference range. Method comparison studies performed with clinical
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specimens demonstrate comparable performance and accuracy, good correlation, and substantial equivalence.
8. Conclusion:
In conclusion, the new devices Genzyme Cystatin C Reagent and Genzyme Cystatin C Calibrator, do not raise any new issues of safety or effectiveness, and are substantially equivalent to the currently marketed Dade Behring devices N Latex Cystatin C test kit (K041878), and N Protein Standard UY calibrator (K003501) respectively, as demonstrated by the descriptions and performance data acquired by Genzyme and summarized in this submission.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings outstretched and its head turned to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Genzyme Corporation c/o Mr. Eric Lawson Manger, Biomedical Regulatory Affairs 31 New York Avenue Framingham, MA 01701
MAY 15 2008
Rc: K080662
Trade/Device Name: Genzyme Cystatin C Reagent and Calibrator Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Codc: NDY and JIT : Dated: March 06, 2008 Received: March 10, 2008
Dear Mr. Lawson:
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).
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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
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Indication for Use
510(k) Number (if known):
Device Name:
Genzyme Cystatin C Reagent Genzyme Cystatin C Calibrator
Indication For Use:
Reagents:
For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use.
Calibrator: For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 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 (OIVD)
Concurrence in 12.11.y
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080662
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§ 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.