(76 days)
Not Found
No
The device description and performance studies focus on the analytical performance of a quantitative in vitro diagnostic test for Cystatin C, using standard laboratory techniques and instrumentation. There is no mention of AI, ML, or any related computational methods for data analysis or interpretation.
No.
The device is an in vitro diagnostic test for measuring cystatin C, used as an aid in the diagnosis and treatment of renal diseases, not a therapeutic device that directly treats or prevents a condition.
Yes
The device quantitatively determines cystatin C in human serum and plasma, and these measurements are "used as an aid in the diagnosis and treatment of renal diseases," which directly indicates a diagnostic purpose.
No
The device description clearly states it is a reagent kit consisting of liquid solutions and latex particles, which are physical components, not software. It is an in vitro diagnostic test used on a specific hardware system (Roche/Hitachi cobas c systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the Tina-quant Cystatin C Gen.2 is an "in vitro test for the quantitative determination of cystatin C in human serum and plasma". It also states that these measurements are used "as an aid in the diagnosis and treatment of renal diseases." This clearly indicates the device is intended for use outside of the body to analyze biological samples for medical purposes.
- Device Description: The description details the reagents used to perform the test on human serum and plasma samples.
- Calibrator and Control: The inclusion of a calibrator and control set, also described as being used with human serum, further supports its use in a laboratory setting for diagnostic testing.
- Performance Studies: The performance studies described (precision, linearity, detection limit, analytical specificity, method comparison, matrix comparison, expected values) are typical evaluations performed for IVD devices to demonstrate their analytical performance and suitability for clinical use.
- Intended User / Care Setting: While it states "For prescription use only" and "For use on Roche/Hitachi cobas c systems," this indicates a professional laboratory setting, which is consistent with the use of an IVD.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tina-quant Cystatin C Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Calibrator:
The C.f.a.s. (Calibrator for automated systems) Cystain C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Control:
The Cystatin C Control Set Gen.2 is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Product codes (comma separated list FDA assigned to the subject device)
NDY, JIT, JJX
Device Description
Roche Tina-quant Cystatin C Gen. 2 reagent provides quantitative measurement of the cystatin C that is present in human serum and plasma.
Assay: Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R I contains solution of polymers in MOPS-buffered saline; preservative, stabilizers. R2 is latex particles in glycine buffer coated with anti-Cystatin C antibodies (rabbit); preservative, stabilizers.
Calibrator:
C.f.a.s. Cystatin C is a liquid, ready-to-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 3 controls based on pooled delipidated human serum enriched with human recombinant Cystatin C produced in E. Coli.
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
Age 21-77
Intended User / Care Setting
For prescription 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)
Precision/reproducibility: Precision was determined according to CLSI EP5-A2. The study included three human serum samples (0.56, 2.80, and 6.39 mg/L) and three control samples in two aliquots per run and two runs per day for 21 days.
Repeatability Summary:
Control 1: Mean (mg/L) = 1.00, SD (mg/L) = 0.02, CV% = 1.7
Control 2: Mean (mg/L) = 1.84, SD (mg/L) = 0.02, CV% = 0.9
Control 3: Mean (mg/L) = 4.12, SD (mg/L) = 0.03, CV% = 0.7
Human Serum 1: Mean (mg/L) = 0.560, SD (mg/L) = 0.010, CV% = 1.8
Human Serum 2: Mean (mg/L) = 2.80, SD (mg/L) = 0.02, CV% = 0.6
Human Serum 3: Mean (mg/L) = 6.39, SD (mg/L) = 0.04, CV% = 0.6
Intermediate Precision:
Control 1: Mean (mg/L) = 1.00, SD (mg/L) = 0.02, CV% = 2.2
Control 2: Mean (mg/L) = 1.84, SD (mg/L) = 0.03, CV% = 1.4
Control 3: Mean (mg/L) = 4.12, SD (mg/L) = 0.06, CV% = 1.4
Human Serum 1: Mean (mg/L) = 0.560, SD (mg/L) = 0.011, CV% = 2.0
Human Serum 2: Mean (mg/L) = 2.80, SD (mg/L) = 0.04, CV% = 1.3
Human Serum 3: Mean (mg/L) = 6.39, SD (mg/L) = 0.07, CV% = 1.1
Linearity/assay reportable range: Linearity was assessed according to CLSI EP6-A with one batch of reagent, in one run, and with samples measured in triplicate. Two separate dilution series differing by sample type (serum and plasma) were prepared with thirteen levels for the plasma series and twenty one levels for the serum series.
Measuring Ranges that are Supported by the Linearity Data (mg/L):
Plasma: Range tested = 0.046 - 8.893, Range found = 0.0 - 8.893, Recommended measuring range = 0.40 - 6.80
Serum: Range tested = 0.0 - 7.578, Range found = 0.00 - 7.578, Recommended measuring range = 0.40 - 6.80
Linear Regression Equation for Serum Y = 1.001x - 0.0057 R2=0.999
Linear Regression Equation for Plasma Y = 1.000x + 0.0000 R2 =0.999
Detection Limit: LoB, LoD, and LoQ studies were performed based upon CLSI EP17-A2.
LoB claim = 0.30 mg/L
LoD claim = 0.40 mg/L
LoQ claim = 0.40 mg/L at % CV of 13.3
Analytical specificity interference from endogenous substances: The reagent was evaluated with four endogenous substances, Hemoglobin, Lipemia, Bilirubin and Rheumatoid factor.
Interference was tested at two levels of Cystatin C. All data passed the acceptance criteria: Recovery within +/- 0.100 mg/L of initial values for samples 1.00mg/L.
Analytical specificity interference from common used drugs: Seventeen commonly used drugs were examined for potential interference. Two sample pools (low and high Cystatin C) were used. All data passed the acceptance criteria: Difference in recovery to the reference sample: 0.1 mg/L, the deviation must be
§ 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
- � '
JUL | 7 2014 510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set
| Date prepared: | July 14th, 2014 |
|---|---|
| Purpose of submission | Roche Diagnostics hereby submits this 510(k) to provide FDA with notification of intent to market a new device named Tina-quant Cystatin C Gen. 2 reagent. This candidate device is a new reagent that was developed by Roche Diagnostics. The Diazyme Cystatin C Assay was cleared in 510(k) K093680 and serves as the predicate device. The candidate reagent uses the same calibrator that was cleared in K080811 and the new Cystatin C Control Set. The new Control Set Gen.2 has three levels compared to the two levels control set which previous cleared in K080811. The Mid level is the only difference between this control set and the one that was cleared in K080811. This submission presents data to support clearance of this new reagent and control. All data in this submission was generated on the cobas c 501 analyzer. |
| Measurand | Cystatin C |
| Type of test | Quantitative turbidimetric method |
| Applicant | Mr. Khoa Tran |
| Roche Diagnostics | |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| Telephone: (317) 521-3409 | |
| Fax: (317) 521-2324 | |
| Email: khoa.tran@roche.com | |
| Candidate device names | Proprietary name: |
| cobas c Tina-quant Cystatin C Gen. 2 | |
| Common name: | |
| Cystatin C Gen. 2 |
1
510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set, Continued
Regulatory information
| Product Code | Classification | Regulation | Panel |
|---|---|---|---|
| NDY | Class II | 21 CFR 862.1225 | |
| (Cystatin C test system) | Clinical | ||
| Chemistry | |||
| JIT | Class II | 21 CFR 862.1150, | |
| (Calibrator, secondary) | Clinical | ||
| Chemistry | |||
| JJX | Class I | 21 CFR 862.1660, (Single | |
| (specified) analyte controls | |||
| (assayed and unassayed)) | Clinical | ||
| Chemistry |
2
510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set, Continued ______________________________________________________________________________________________________________________________________________________________________________
Intended use In vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas e systems. Indications for Tina-quant Cystatin C Gen. 2 assay: The Tina-quant Cystatin C Gen. 2 is an in vitro test for the quantitative use determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. C.f.a.s. Cystatin C: The C.f.a.s. Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. Cystatin C Control Set Gen.2: The 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. Special For prescription use only conditions for use Special For use on Roche/Hitachi cobas c systems instrument requirements Roche Tina-quant Cystatin C Gen. 2 reagent provides quantitative Candidate device measurement of the cystatin C that is present in human serum and plasma. description Assay: Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R I contains solution of polymers in MOPS-buffered saline; preservative, stabilizers. R2 is latex particles in glycine buffer coated with anti-Cystatin C antibodies (rabbit); preservative, stabilizers.
3
Calibrator:
C.f.a.s. Cystatin C is a liquid, ready-to-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 3 controls based on pooled delipidated human serum enriched with human recombinant Cystatin C produced in E. Coli.
Predicate device
Diazyme Cystatin C Assay was cleared in K093680 on the Hitachi 917 analyzer for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. C.f.a.s Cystatin C calibrator and Cystatin C Control Set were cleared in K080811 on Hitachi 917, MODULAR P, cobas c 501.
4
510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set, Continued
The following table compares the identical features of the candidate device to Substantial equivalence the predicate device that was cleared in 510(k) K093680 and K080811. similarities
| Feature | Predicate Device:
Diazyme Cystatin C | Candidate Device:
Tina-Quant Cystatin C Gen.
2 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Diazyme Cystatin C Assay is an
in-vitro diagnostic test for the
quantitative determination of
Cystatin C in serum or plasma by
latex enhanced immunoturbidimetric
method. The measurement of
Cystatin C is used as an aid in the
diagnosis and treatment of renal
disease. | The Tina-Quant Cystatin C
Gen.2 is an in vitro test for the
quantitative 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. |
| Sample Types | Serum and plasma | Same |
| Permissible
Anticoagulants | Li-heparin plasma
K2-EDTA plasma | Li-heparin plasma
K2-EDTA, K3-EDTA plasma |
| Reference Method | colorimetric method | Same |
| Calibrator | 5 Levels Cystatin C Calibrators and
saline as the zero calibrator. | C.f.a.s. (Calibrator for
automated systems), single
level and use water as the zero
calibrator.
(C.f.a.s. cleared for use with
Cystatin C assay in 510(k)
K080811) |
| Calibration Stability | Any calibration frequency is
dependent on instrument used.
Additionally, that assay should be
recalibrated and controls run with
each new lot of reagent. | After reagent lot change and
as required following quality
control procedures. |
| Reagent Shelf Life
Stability | Unopened: 2-8 °C until expiration
date
On-board in use:
4 weeks | Unopened: 2-8 °C until
expiration date
On-board in use:
8 weeks |
| Calibration Mode | 6-point: Spine | Same |
5
| Traceability | Standardized against the Doumas manual reference method | Assay: This method has been standardized against ERM-DA471/IFCC reference material.
Calibrator: The Cystatin C calibrator is traceable to ERM-DA471/IFCC reference material. The value assignment was carried out by turbidimetry on Hitachi 917 analyzer.
Control: The Cystatin C control is traceable to ERM-DA471/IFCC reference material. The value assignment was carried out by turbidimetry on Hitachi 917 analyzer. |
|---------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument Platform | Hitachi 917 analyzer | cobas c 501 analyzer |
.
Continued on next page
.
6
The following table compares the different features of the candidate device to Substantial equivalence the predicate device that was cleared in 510(k) K093680 and K080811. differences
| Feature | Predicate Device:
Diazyme Cystatin C | Candidate Device:
Tina-Quant Cystatin C Gen. 2 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Composition | R1:
100 mM Tris-buffer Solution
R2:
Suspension of anti-human Cystatin C chicken polyclonal antibody coated latex particles ( The reagent has been evaluated for transport, shelf-life, and open on-board stability.
10
510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set. Continued
Detection Limit LoB, LoD, and LoQ studies were performed based upon CLSI EP17-A2.
LoB Protocol: One blank sample was tested in n=5 with two analyzers with three reagent batches for six runs per day across three days.
LoD Protocol: Five low-analyte samples were measured in singlicate on two analyzers with three reagent batches for six runs per day across three days.
LoQ Protocol: A low Level Sample Set was prepared by diluting 5 human serum samples with an analyte free diluent (0.9% NaCl). The Low level Sample Set was tested in 2 replicates per sample on 5 days, one runs per day on one cobas c 501 analyzers. The mean concentration is plotted versus the % CV. The concentration at % CV of 13.3 is the LoQ.
The LoB, LoD, and LoQ claims represent the specifications for each.
LoB claim = 0.30 mg/L LoD claim = 0.40 mg/L LoQ claim = 0.40 mg/L at % CV of 13.3
11
Analytical specificity interference from endogenous substances
The reagent was evaluated with four endogenous substances, Hemoglobin, Lipemia, Bilirubin and Rheumatoid factor for potential interference with the measurement of Cystatin C.
One pool of human serum was spiked with the interferent. A second pool of human serum contained none. The two pools were mixed in different ratios to yield a dilution series with varying concentrations of the interferent.
The endogenous interference data are summarized in the table. Interference was tested at two levels of Cystatin C.
| | no interference up
to | Claim as it appears in the
labeling. |
|-----------------------------------|--------------------------|-----------------------------------------|
| Lipemia Level 1 | 2334 L index | No significant interference up |
| Lipemia Level 2 | 2364 L index | to an L index of 1000. |
| Hemolysis Level 1 | 1313 H index | No significant interference up |
| Hemolysis Level 2 | 1461 H index | to an H index of 1000. |
| Unconjugated Bilirubin
Level 1 | 77 H index | No significant interference up |
| Unconjugated Bilirubin
Level 2 | 73 H index | to an I index of 60. |
| Rheumatoid factor Level 1 | 1301 mg/L | Rheumatoid factor 1.00mg/L.
12
Analytical Seventeen commonly used drugs were examined for potential interference on specificity measurement with cobas c Tina-Quant Cystatin C Gen. 2 reagent. interference Two sample pools, containing a low and high concentration of Cystatin C are from common used. These sample pools are divided into an appropriate number of aliquots. drugs One aliquot is not spiked with the drugs and it is used as the reference sample for Cystatin C concentration. The Cystatin C concentration in the sample is determined with n = 3 measurements on a cobas c 501 analyzer.
The other sample aliquots, with either the high or low Cystatin C concentrations, are spiked with the respective amount of drug. The Cystatin C concentration of the spiked aliquots are determined in triplicate and the mean of the triplicate determinations is compared to the Cystatin C concentration determined for the reference aliquot (mean of n=3).
| | Drug | Highest Concentration Shown
Not to Interfere with Cystatin C
(drug concentrations in mg/L) |
|----|----------------------|--------------------------------------------------------------------------------------------------|
| 1 | Acetylcystein | 150 |
| 2 | Ampicillin - Na | 1000 |
| 3 | Ascorbic acid | 300 |
| 4 | Cyclosporine | 5 |
| 5 | Cefoxitin | 2500 |
| 6 | Heparin | 5000U |
| 7 | Intralipid | 10000 |
| 8 | Levodopa | 20 |
| 9 | Methyldopa + 1.5 | 20 |
| 10 | Metronidazole | 200 |
| 11 | Phenylbutazone | 400 |
| 12 | Doxycyclin | 50 |
| 13 | Acetylsalycilic acid | 1000 |
| 14 | Rifampicin | 60 |
| 15 | Acetaminophen | 200 |
| 16 | Ibubrofen | 500 |
| 17 | Theophylline | 100 |
The table below summarizes the common drug interferences data:
All data passed the following acceptance criteria:
Difference in recovery to the reference sample: ≤± 10%
13
| Method
comparison
with predicate
device | A total of 103 human serum samples were tested in singlicate with the
Cystatin C reagent from Diazyme on one Modular P and the CYSC2 reagent
on one cobas c 501 analyzer.
Cystatin C values for n=103 human sera adult samples were obtained using
the candidate reagent (y-axis) to the predicate reagent (x-axis) on the
Roche/Hitachi cobas c 501 analyzer. Candidate sample concentrations
ranged from 0.500 to 6.67 mg/L, and they were tested in singlicate. The
values were regressed using the Passing/Bablok model to produce the
following equation. | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | Passing/Bablok | Linear regression |
| | $Y = 0.997x - 0.064$ mg/L | $y = 1.031x - 0.153$ mg/L |
| | $T = 0.937$ | $r = 0.988$ |
and the same of the same of the same of the same of the same of
and the state of the state of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the sta
14
Matrix comparison
Lithium-heparin, K2-EDTA and K3-EDTA are permissible anticoagulants for use with this reagent because they do not interfere with recovery of Cystatin C. In an internal study, a total of 57 tubes were collected per anticoagulant. Plasma results were compared to serum results and percent recovery was determined. In terms of % recovery. All data passed the following criteria: For sample concentrations ≤ 0.1 mg/L, the deviation must be ≤ ± 10 mg/L. For sample concentrations > 0.1 mg/L, the deviation must be ≤± 10%.
| anticoagulants | Sample concentration
range tested (mg/L) | Claimed Measuring
Range (mg/L) |
|---------------------|---------------------------------------------|-----------------------------------|
| Li-Heparin (full) | 0.560 - 6.63 | |
| Li-Heparin (half) | 0.650 - 5.04 | |
| K2-EDTA (full) | 0.550 - 6.67 | 0.40 - 6.80 |
| K2-EDTA (half) | 0.630 - 5.05 | 0.40 - 6.80 |
| K3-EDTA (full) | 0.580 - 6.72 | 0.40 - 6.80 |
| K3-EDTA (half) | 0.620 - 4.89 | 0.40 - 6.80 |
| Gel Separation Tube | 0.510 - 6.55 | 0.40 - 6.80 |
In addition, method comparisons with plasma vs. serum were calculated with the following results:
| Serum vs. Li-heparin | P/B: y = 1.010x + 0.020, r = 1.000 |
|---|---|
| Serum vs. K2-EDTA | P/B: y = 1.020x - 0.010, r = 1.000 |
| Serum vs. K3-EDTA | P/B: y = 1.030x + 0.000, r= 1.000 |
| Serum vs. Gel Separation | P/B: y = 1.000x - 0.010, r = 1.000 |
Continued on next page
Page 15 of 16
15
です。そしても、そしてもない。
そしても、その後になっています。
「もっという」ということです。
「もっということです。」
「いない」ということです。」
「いない」ということです。」
「いない」ということです。」
「いない」ということです。」
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「『
510(k) Summary for Tina-quant Cystatin C Test System, Calibrator and Control Set, Continued .
| Expected
values/
| reference range | Age 21-77 | 0.61 - 0.95 mg/L |
|---|---|---|
| Samples of subjects from US panel of healthy subjects were used as a | ||
| reference population (n=273) measured with Roche Tina-quant Cystatin C | ||
| Gen.2. They were evenly distributed across gender and age between 21 and | ||
| 77 years. | ||
| The analysis of the data with the 2.5% and the 97.5 % percentile gave a | ||
| Cystatin C range for from 0.61 mg/L to 0.95 mg/L. | ||
| Conclusion | The submitted information in this premarket notification supports a | |
| substantial equivalence decision. |
16
Image /page/16/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17,2014
ROCHE DIAGNOSTICS KHOA TRAN REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416
Re: K141143
Trade/Device Name: Tina-quant Cystatin C Gen.2 Assay, C.f.a.s (Calibrator for automated systems) Cystatin C, Cystatin C Control Set Gen. 2 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: NDY, JIT, JJX Dated: May 1, 2014 Received: May 2, 2014
Dear Mr. Khoa Tran:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
17
Page 2-Mr. Tran
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation cntitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Katherine Serrano -5 For : Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics
and Radiological Health Center for Devices and Radiological Health
Enclosure
18
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K141143
Device Name
Tina-quant Cystatin C Gen.2 Assay, C.f.a.s (Calibrator for automated systems) Cystatin C Control Set Gen.2
Indications for Use (Describe)
The Tina-quant Cystatin C Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on RochePlitachi cobas c systems. Cystatin C messurements are used as an aid in the diagnosis and treatment of renal diseases.
Calibrator:
The C.f.a.s. (Calibrator for automated systems) Cystain C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Control:
The Cystatin C Control Set Gen.2 is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
14 11:14:
19
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