K Number
K161817
Device Name
Tina-quant Cystatin C Gen.2
Date Cleared
2016-07-27

(26 days)

Product Code
Regulation Number
862.1225
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tina-quant Cystatin 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.
Device Description
The Roche Tina-quant Cystatin C Gen.2 assay provides quantitative measurement of the cystatin C that is present in human serum and plasma. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R1 contains a solution of polymers in MOPS-buffered saline with preservative and stabilizers. R2 is latex particles coated with anti-cystatin C antibodies (rabbit) in glycine buffer with preservatives and stabilizers. Human cystatin C agglutinates with the antibody coated latex particles. The aggregate is determined turbidimetrically.
More Information

No
The device description and performance studies describe a turbidimetric immunoassay for measuring cystatin C. There is no mention of AI or ML in the text.

No.
This device is an in vitro diagnostic test used for quantitative determination of cystatin C, which aids in the diagnosis and treatment of renal diseases. It does not directly provide therapy.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases," indicating its role in the diagnostic process.

No

The device is an in vitro diagnostic test that involves chemical reagents and a turbidimetric measurement on a hardware analyzer (Roche/Hitachi cobas c systems). It is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro test for the quantitative determination of cystatin C in human serum and plasma". This is a key characteristic of an IVD.
  • Device Description: The description details the reagents used to analyze human serum and plasma samples outside of the body. This is the definition of an in vitro test.
  • Input Imaging Modality and Anatomical Site: The "Not Applicable (In vitro diagnostic test)" entries for these sections further confirm that the device operates on samples taken from the body, not on the body itself.

N/A

Intended Use / Indications for Use

Tina-quant Cystatin 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.

Product codes (comma separated list FDA assigned to the subject device)

NDY

Device Description

The Roche Tina-quant Cystatin C Gen.2 assay provides quantitative measurement of the cystatin C that is present in human serum and plasma. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2).

R1 contains a solution of polymers in MOPS-buffered saline with preservative and stabilizers. R2 is latex particles coated with anti-cystatin C antibodies (rabbit) in glycine buffer with preservatives and stabilizers.

Human cystatin C agglutinates with the antibody coated latex particles. The aggregate is determined turbidimetrically.

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

Prescription Use

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)

4.1. Sample stability
Human serum and plasma (Li-heparin, K2-EDTA, K3-EDTA) patient samples are adjusted with cystatin C to cover the Tina-quant Cystatin C Gen.2 assay reportable measuring range. These samples are split into two sets, one set stored at 15-25 °C and the other at 2-8 °C. The samples are tested in triplicate on a cobas c 501 analyzer, and the median value is used to calculate the % difference from the result of the fresh sample at time zero.

4.2. High dose hook-effect
A human serum pool is adjusted to obtain a cystatin C concentration of > 24 mg/L. A 18 step dilution series is prepared by diluting with 0.9 % saline. These samples are tested on the cobas c 501 analyzer and the known concentration is compared to the result reported by the analyzer.

4.3. HARA interference
A customer inquiry made Roche aware of the potential for interference with Tina-quant Cystatin C Gen.2 assay test results in patient samples containing human anti rabbit antibodies (HARA). Internal testing was done at Roche to confirm the customer results.

This testing, customer information, and the information presented in the peer reviewed and published literature reference cited in the method sheet, support the addition of a warning statement, regarding the use of patient samples containing HARA, to the Limitations and interference section of the method sheet.

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.

K141143

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.

K080811, K141143

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ROCHE DIAGNOSTICS OPERATIONS (RDO) PATRICK STIMART REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250

July 27, 2016

Re: K161817

Trade/Device Name: Tina-quant Cystatin C Gen.2 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: NDY Dated: June 27, 2016 Received: July 1, 2016

Dear Mr. Patrick Stimart:

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 (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.

1

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "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 -S

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

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Indications for Use

510(k) Number (if known) K161817

Device Name Tina-quant Cystatin C Gen.2

Indications for Use (Describe)

Tina-quant Cystatin 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over The Counter Use (21 CFR 801 Subpart C)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Tina-quant Cystatin C Gen.2 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification Special 510(k).

The purpose of this Special 510(k) Premarket Notification is to inform FDA of the proposed modifications to the Tina-quant Cystatin C Gen.2 labeling and provide sufficient detail to support a determination of substantial equivalence. The primary change is the addition and expansion of sample stability claims. Other changes that will also be addressed are a reduction in the hook effect interference level claim and the addition of a warning against testing of patient samples containing human anti-rabbit antibodies (HARA).

Note: There were no prior submissions for this device for which FDA provided feedback related to the data or information needed to support substantial equivalence.

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Submitter NameRoche Diagnostics
Address9115 Hague Road
P.O. Box 50416
Indianapolis, IN 46250-0415
ContactPrimary:
Patrick Stimart
Phone (317) 521-3954
FAX (317) 521-2324
Email: patrick.stimart@roche.com

Secondary:
Miranda Deverall
Phone (317) 521-2897
FAX (317) 521-2324
Email: miranda.deverall@roche.com |
| Date Prepared | June 24, 2016 |
| Proprietary Name | Tina-quant Cystatin C Gen.2 |
| Common Name | Cystatin C Gen.2 |
| Classification Name | Cystatin C test system (21CFR862.1225, Class 2 device) |
| Product Codes | NDY |
| Predicate Devices | The candidate device is a modification of the predicate device. The
device name, Tina-quant Cystatin C Gen.2, is unchanged from how it
was cleared in 510(k) K141143 |
| Establishment Registration | For the Tina-quant Cystatin C Gen.2, the establishment registration
number for Roche Diagnostics GmbH in Mannheim, Germany is
9610126, and for Penzberg, Germany, 9610529. The establishment
registration number for Roche Diagnostics in the United States is
1823260. |

5

1. DEVICE DESCRIPTION

The Roche Tina-quant Cystatin C Gen.2 assay provides quantitative measurement of the cystatin C that is present in human serum and plasma. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2).

R1 contains a solution of polymers in MOPS-buffered saline with preservative and stabilizers. R2 is latex particles coated with anti-cystatin C antibodies (rabbit) in glycine buffer with preservatives and stabilizers.

Human cystatin C agglutinates with the antibody coated latex particles. The aggregate is determined turbidimetrically.

Note: Since Tina-quant Cystatin C Gen.2 is a reagent, drawings, schematics, illustrations, photos and figures are not pertinent to describe the device and therefore are not present in this submission.

2. INDICATIONS FOR USE

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.

Note: The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

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TECHNOLOGICAL CHARACTERISTICS 3.

The candidate device. Tina-quant Cystatin C Gen.2, has been modified from the predicated device with the addition of the following information to the assay method sheet.

  • Added new room temperature and refrigerated serum and plasma sample stability information to the Specimen collection and preparation section.
  • Added a warning to the Limitations and interference section regarding elevated cystatin . C results in patient samples containing human anti-rabbit antibodies (HARA)
  • In the Limitations and interference section, the Hook-effect limit was changed from 20 . mg/L to a more conservative 12 mg/L.

The following tables compare the Tina-quant Cystatin C Gen.2 with its predicate device, Tinaquant Cystatin C Gen.2 (K141143).

| Feature | Predicate Device Tina-quant Cystatin C
Gen.2 (K141143) | Candidate Device Tina-quant
Cystatin C Gen.2 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended use / Indications for use | 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. | same |
| Test principle | Particle enhanced immunoturbidimetric
assay | same |
| Instrument | Roche/Hitachi cobas c 501 | same |
| Sample type | Serum, Li-heparin, K2-, and K3- EDTA
plasma | same |
| Calibrator | C.f.a.s. Cystatin C | same |
| Calibration frequency | After reagent lot change and after 90 days | same |
| Controls | Cystatin C Control Set Gen.2 | same |
| Traceability/Standardization | This method has been standardized against
ERM-DA471/IFCC | same |
| Reagent stability | Shelf life at 2-8°C: See expiration date on
cobas c pack label
On-board in use and refrigerated on the
analyzer: 8 weeks | same |

Table 1 Assay Comparison, General Assay Features

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| Feature | Predicate Device Tina-quant Cystatin C
Gen.2 (K141143) | Candidate Device Tina-quant Cystatin
C Gen.2 |
|-------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring Range | 0.40 - 6.80 mg/L | Same |
| Precision | See predicate method sheet | Same |
| LoB | 0.30 mg/L | Same |
| LoD | 0.40 mg/L | Same |
| LoQ | 0.40 mg/L | Same |
| Hook effect | No false result occurs up to a cystatin C
concentration of 20 mg/L. | No false result occurs up to a cystatin C
concentration of 12 mg/L. |
| Method Comparison | See predicate method sheet | Same |
| Limitations -
interference | See predicate method sheet | Same as predicate except for the
following change and addition:
"High dose hook-effect: No false result
occurs up to a cystatin C concentration
of 20 mg/L " was changed to
"High dose hook-effect: No false result
occurs up to a cystatin C concentration
of 12 mg/L"
The warning statement "In very rare
cases falsely elevated results for Cystatin
C will be obtained from samples taken
from patients who have been treated with
rabbit antibodies or have developed anti-
rabbit antibodies." was added along with
the supporting reference number 33
Kricka LH. Human Anti-Animal
Antibody Interferences in
Immunological Assays. Clin Chem
1999;45(7):942-956. |

Table 2: Assay Comparison, Labeled Performance Characteristics

NON-CLINICAL PERFORMANCE EVALUATION 4.

Based on the risk analysis, the modifications to the Tina-quant Cystatin C Gen.2 method sheet did not introduce any new risks to the performance of the assay.

To address the modifications, verification and validation activities, which are summarized below, demonstrated that all of the acceptance criteria were met.

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4.1. Sample stability

Human serum and plasma (Li-heparin, K2-EDTA, K3-EDTA) patient samples are adjusted with cystatin C to cover the Tina-quant Cystatin C Gen.2 assay reportable measuring range. These samples are split into two sets, one set stored at 15-25 °C and the other at 2-8 °C. The samples are tested in triplicate on a cobas c 501 analyzer, and the median value is used to calculate the % difference from the result of the fresh sample at time zero.

4.2. High dose hook-effect

A human serum pool is adjusted to obtain a cystatin C concentration of > 24 mg/L. A 18 step dilution series is prepared by diluting with 0.9 % saline. These samples are tested on the cobas c 501 analyzer and the known concentration is compared to the result reported by the analyzer.

4.3. HARA interference

A customer inquiry made Roche aware of the potential for interference with Tina-quant Cystatin C Gen.2 assay test results in patient samples containing human anti rabbit antibodies (HARA). Internal testing was done at Roche to confirm the customer results.

This testing, customer information, and the information presented in the peer reviewed and published literature reference cited in the method sheet, support the addition of a warning statement, regarding the use of patient samples containing HARA, to the Limitations and interference section of the method sheet.

ADDITIONAL INFORMATION 5.

The Tina-quant Cystatin C Gen.2 assay will continue to use the current C.f.a.s. Cystatin C (K080811) for calibration, and the Cystatin C Control Set Gen.2 (K141143) for quality control. There have been no changes to the C.f.a.s. Cystatin C and the Cystatin C Control Set Gen.2.

CONCLUSIONS 6.

The submitted information in this premarket notification supports a substantial equivalence decision. The differences between predicated and candidate do not impact the indications for use or technological characteristics.