(88 days)
Not Found
No
The device description and performance studies focus on a standard immunoturbidimetric assay and associated calibrators and controls, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic (IVD) assay used to quantitatively determine cystatin C levels, which aids in the diagnosis and treatment of renal diseases. It does not directly provide therapy or treatment to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases," indicating that this device directly contributes to diagnosing a medical condition.
No
The device description clearly outlines physical components (reagents, calibrators, controls) and their interaction with automated clinical chemistry analyzers, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is for "quantitative in vitro determination of cystatin C in human serum and lithium-heparin plasma". The term "in vitro" is a key indicator of an IVD. It also mentions its use as an "aid in the diagnosis and treatment of renal diseases," which is a diagnostic purpose.
- Device Description: The description of the assay, calibrator, and control all describe components used to perform a test on biological samples (serum and plasma) outside of the body.
- Professional Use: The "Intended User / Care Setting" indicates "professional use only," which is typical for IVD devices used in clinical laboratories.
- Performance Studies: The mention of performance studies and key metrics like CV (Coefficient of Variation) are standard for evaluating the analytical performance of IVD tests.
- Predicate Device: The mention of a "Predicate Device" with a K number (K041627) indicates that this device is being compared to a previously cleared IVD device.
All of these factors strongly point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Reagent: Immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and lithium-heparin plasma on Roche automated clinical chemistry analyzers. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Calibrator: Cfas (Calibrator for automated systems) Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Control: Cystatin C Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Product codes
NDY, JIT, JJX
Device Description
Assay: The Roche Tina-quant Cystatin C is an immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and plasma on Roche automated clinical chemistry analyzers. The test principle is a particle enhanced immunoturbidimetric assay. Human cystatin C agglutinates with latex particles coated with anti-cystatin C antibodies. The precipitate is determined turbidimetrically.
Calibrator: Cfas Cystatin C is a liquid, ready-for-use calibrator based on pooled delipidated human serum enriched with recombinant human cystatin C produced in E. Coli. Single level calibrators with lot specific values are diluted on board the analyzer to create a 6-point calibration curve.
Control: Cystatin C Control Set contains 2 controls based on pooled delipidated human serum enriched with human recombinant cystatin C produced in E. Coli. The adjusted concentrations of the control component are in the low concentration range for Control Low and the elevated concentration range for Control High.
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
Not Found
Summary of Performance Studies
The Hitachi 917 Cystatin C test system was evaluated for several performance characteristics described within the submission. In addition, the traceability, value assignment process, and stability of the Cfas Cystatin C calibrator and Cytatin C Control set are described.
Key Metrics
Precision:
Within run CV:
0.91% @ 4.48 mg/L
0.97% @ 0.95 mg/L
1.71% @ 0.75 mg/L
0.67% @ 5.14 mg/L
Total CV:
2.50% @ 4.35 mg/L
3.13% @ 0.94 mg/L
3.76% @ 0.73 mg/L
2.36% @ 4.98 mg/L
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Koso8//
JUN 2 0 2008
510(k) Summary - Roche Tina-quant Cystatin C, Calibrator and Control Set
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence Submitter Roche Diagnostics name, address. 9115 Hague Rd contact Indianapolis IN 46250 (317) 521-7637 Contact person: Kerwin Kaufman Date prepared: May 30, 2008 Assay: Device Name Proprietary name: Tina-quant Cystatin C Common name: Cystatin C Classification name: Test, Cystatin C Calibrator: Proprietary name: Cfas (Calibrator for automated systems) Cystatin C Common name: Cystatin C calibrator Classification name: Calibrator, secondary Control: Proprietary name: Cystatin C Control Set Common name: Cystatin C Ouality control material (assayed) Classification name: Single (specified) analyte controls (assayed and unassayed) Device Assay: Description The Roche Tina-quant Cystatin C is an immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and plasma on Roche automated clinical chemistry analyzers. The test principle is a particle enhanced immunoturbidimetric assay. Human cystatin C agglutinates with latex particles coated with anti-cystatin C antibodies. The precipitate is determined turbidimetrically.
Continued on next page
1
510(k) Summary – Roche Tina-quant Cystatin C, Calibrator and Control Set, Continued ______________________________________________________________________________________________________________________________________________________________________________
| Device
Description
(continued) | Calibrator:
Cfas Cystatin C is a liquid, ready-for-use calibrator based on pooled
delipidated human serum enriched with recombinant human cystatin C
produced in E. Coli. Single level calibrators with lot specific values are
diluted on board the analyzer to create a 6-point calibration curve. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Control:
Cystatin C Control Set contains 2 controls based on pooled delipidated human
serum enriched with human recombinant cystatin C produced in E. Coli.
The adjusted concentrations of the control component are in the low
concentration range for Control Low and the elevated concentration
range for Control High. |
| Intended use | Assay:
Immunoturbidimetric assay for the quantitative in vitro determination of
cystatin C in human serum and plasma on Roche automated clinical
chemistry analyzers. |
| | Calibrator:
Cfas (Calibrator for automated systems) Cystatin C is for use in the
calibration of quantitative Roche methods on Roche clinical chemistry
analyzers as specified in the value sheets. |
| | Control:
Cystatin C Control Set is for use in quality control by monitoring accuracy
and precision for the quantitative methods as specified in the value sheets. |
| Predicate
Device | We claim substantial equivalence to the DakoCytomation Cystatin C
Immunoparticles, Cystatin C Calibrator Kit and Cystatin C Control Set
cleared in 510(k) K041627. |
| Substantial
equivalency -
Reagent | The table below provides a comparison of the predicate device,
DakoCytomation Cystatin C Immunoparticles (K041627) and the new device
Roche Tina-quant Cystatin C. |
.
:
2
| Feature | Predicate device:
DakoCytomation Cystatin C
Immunoparticles (K041627) | New Device:
Roche Tina-quant Cystatin C |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
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. | Immunoturbidimetric assay for the
quantitative in vitro determination
of cystatin C in human serum and
plasma on Roche automated
clinical chemistry analyzers.
Cystatin C measurements are used
as an aid in the diagnosis and
treatment of renal diseases. |
| Specimen type | Serum, heparinized plasma, EDTA
plasma | Serum and Lithium-heparinized
plasma |
| Method | Particle enhanced
immunoturbidimetric assay | Same |
| Traceability /
Standardization | The cystatin C value assignment has
been carried out by turbidimetry
using a precise transfer protocol
ensuring traceability to a pure
recombinant cystatin C reference
preparation, where the cystatin C
concentration was established by
dry mass determination. | This method has been standardized
against an in-house reference
preparation of pure recombinant
human cystatin C. The cystatin C
concentration of this reference
preparation was established by dry
mass determination as described in
reference. |
| Reagent Storage | 2 - 8°C | 2 - 8°C |
| Calibrator | DakoCytomation Cystatin C
Calibrator, single level
Diluted to form a 6-point calibration
curve | C.f.a.s. Cystatin C Calibrator,
single level
Diluted to form a 6-point
calibration curve |
| Quality control | DakoCytomation Cystatin C Control
Set, 2-level | Cystatin C Control Set, 2-level |
| Expected values | Individuals 1-50 years:
0.55-1.15 mg/L
Individuals > 50 years:
0.63-1.44 mg/L | Same |
| Analyzers | Hitachi 911, Hitachi 917,
MODULAR P, Cobas Mira Plus and
IMMAGE | Hitachi 917, MODULAR P, and
cobas c 501 |
| Measuring
Range | ~0.4 - 7.5 mg/L | 0.4 - 8.0 mg/L |
| Method
comparison
with Dako
predicate | Passing Bablok: y = $1.009x + 0.019$
$\tau = 0.96$
Linear regression: y = $1.014x + 0.011$
$r = 0.999$ | |
| Precision | | Within run CV:
0.91% @ 4.48 mg/L
0.97% @ 0.95 mg/L
1.71% @ 0.75 mg/L
0.67% @ 5.14 mg/L |
| | Total CV:
2.1% @ 3.95 mg/L
2.6% @ 0.96 mg/L
5.9% @ 0.45 mg/L
2.0% @ 1.71 mg/L
2.3% @ 5.37 mg/L | Total CV:
2.50% @ 4.35 mg/L
3.13% @ 0.94 mg/L
3.76% @ 0.73 mg/L
2.36% @ 4.98 mg/L |
| Limitations | Bilirubin, conjugated:
No interference was found for
conjugated bilirubin up to 600 mg/L
(60 mg/dL).
Bilirubin, unconjugated:
No interference was found for
unconjugated bilirubin up to 600
mg/L (60 mg/dL).
Hemoglobin:
No interference was found for
hemoglobin up to 10 g/L (1000
mg/dL).
Triglyceride:
No interference was found for
triglyceride up to 15 g/L (1500
mg/dL).
Rheumatoid Factor:
No interference was found for
rheumatoid factor up to 1200
IU/mL.
No antigen excess is found for
cystatin C concentrations below 28
mg/L (the highest concentration
tested).
All drugs described in reference 7
were investigated according to the
recommendations in reference 7.
No interference was observed. | Icterus: No significant interference
up to an I index of 60 (approximate
conjugated and unconjugated
bilirubin concentration: 60 mg/dL
or 1026 μmol/L).
Hemolysis: No significant
interference up to an H index of
700 (approximate hemoglobin
concentration: 700 mg/dL or 435
μmol/L).
Lipemia (Intralipid): No significant
interference up to an L index of
1000.
There is poor correlation between
the L index (corresponds to
turbidity) and triglycerides
concentration.
Rheumatoid factors 20.0
mg/L.
Drugs: No interference was found
at therapeutic concentrations
using common drug panels (see
references 18 and 19 in labeling).
In very rare cases gammopathy, in
particular type IgM Waldenström's
macroglobulinemia), may cause
unreliable results. |
.
3
4
| Substantial | The table below provides a comparison of the predicate device, |
|---|---|
| equivalency - | DakoCytomation Cystatin C Calibrator (K041627) and the new device, Cfas |
| Calibrator | (Calibrator for automated systems) Cystatin C. |
| Feature | Predicate device:
DakoCytomation Cystatin C
Calibrator (K041627) | New Device:
Roche Cfas (Calibrator for
automated systems) Cystatin C |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Cystatin C Calibrator is intended for
establishing calibration curves for
the quantitative immunological
determination of human cystat C by
turbidimetry or nephelometry. | Cfas (Calibrator for automated
systems) Cystatin C is for use in the
calibration of quantitative Roche
methods on Roche clinical
chemistry analyzers as specified in
the value sheets. |
| Analyte | Cystatin C | Same |
| Matrix | A liquid pool of delipidated human
serum enriched with recombinant
human cystatin C produced in E.
coli and preservative. | Same |
| Storage | 2 – 8 °C | Same |
| Substantial | The table below provides a comparison of the predicate device, |
|---|---|
| equivalency - | DakoCytomation Cystatin C Control Set (K041627) and the new device |
- Control Set
DakoCytomation Cystatin C Control Set (K041627) and the new device,
Roche Cystatin C Control Set.
| Feature | Predicate device:
DakoCytomation Cystatin C
Control Set (K041627) | New Device:
Roche Cystatin C Control Set |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | Cystatin C Control Set is for use in
quality control by monitoring
accuracy and precision for the
quantitative methods as specified in
the value sheets. |
| Analyte | Cystatin C | Same |
| Matrix | 2-level set with low and high
cystatin C levels, based on liquid
pools of delipidated human serum
enriched with recombinant human
cystatin C produced in E. coli and
preservative. | Same |
| Storage | 2 – 8 °C | Same |
5
| Performance | evaluation | The Hitachi 917 Cystatin C test system was evaluated for several
performance characteristics described within the submission. |
|-------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | In addition, the traceability, value assignment process, and stability of
the Cfas Cystatin C calibrator and Cytatin C Control set are described. |
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Kerwin Kaufman 9115 Hague Road Indianapolis, In 46250
JUN 2 0 2008
Re: K080811 Trade Name: Tina-Quant Cystatin C Regulation Number: 21 CFR 862.1225 Regulation Name: Test, Cystatin C Regulatory Class: Class II Product Codes: NDY, JIT, JJX Dated: March 21, 2008 Received: March 24, 2008
Dear Kerwin Kaufman:
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).
7
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 1 logal/y 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 tolloffee 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.
Téan 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
8
Indications for Use
KOSORII 510(k) Number (if known):
Device Name: Roche Tina-quant Cystatin C, Calibrator and Controls
Indications For Use:
Reagent:
Immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and lithium-heparin plasma on Roche automated clinical chemistry analyzers. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Calibrator:
Cfas (Calibrator for automated systems) Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Control:
Cystatin C Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Prescription Use XXX (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 In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
-Page 1 of
Office of In Vitro Diagnostic Device Rvaluation and Safety