(259 days)
No.
The device description outlines an automated clinical chemistry assay using particle-enhanced turbidimetric immunoassay (PETIA) principles, where measurements are based on proportional changes in absorbance due to agglutination. There are no mentions of AI, ML, or DNN, nor does the system describe or imply any sophisticated learning algorithms or data-driven decision-making processes beyond standard analytical chemistry principles.
No
The device is an in vitro diagnostic test used to measure cystatin C levels, which aids in the diagnosis and treatment of renal diseases. It does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Cystatin C assay is an in vitro diagnostic test..." and "Measurement of cystatin C aids in the diagnosis and treatment of renal diseases." This directly identifies it as a diagnostic device.
No
The device is an in vitro diagnostic test that quantitatively measures cystatin C in human samples using a turbidimetric immunoassay on an automated clinical chemistry system. This involves physical reagents and a specialized instrument, not solely software.
Yes
The product is explicitly stated as an "in vitro diagnostic test" in the intended use section, and it quantitatively determines a substance in human serum and plasma to aid in the diagnosis and treatment of renal diseases.
N/A
Intended Use / Indications for Use
The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system.
Measurement of cystatin C aids in the diagnosis and treatment of renal diseases.
For laboratory professional use only.
Product codes
NDY
Device Description
The Cystatin C assay is an automated clinical chemistry assay.
Cystatin C is a particle-enhanced turbidimetric immunoassay (PETIA) developed to accurately and reproducibly measure cystatin C levels in serum and plasma. Latex particles coated with anti-human cystatin C antibody agglutinate when mixed with sample containing human cystatin C. The change in absorbance due to agglutination of the reaction mixture is proportional to the quantity of human cystatin C in the sample.
The Cystatin C assay on Alinity c system is aligned to the certified reference material ERM-DA471/IFCC.
The Cystatin C Calibrators are manufactured gravimetrically and are referenced to European Reference Material ERM-DA471/IFCC at each concentration level.
Each Cystatin C cartridge contains 2 ready to use liquid reagents (R1 and R2).
Reagent 2: latex particles coated with rabbit IgG against human cystatin C (0.09%)
Inactive ingredients:
Reagent 1: buffer and stabilizers. Preservative: sodium azide ( 80 (mL/min/1.73 m²).
Key Results: Adult reference range 0.59–1.28 mg/L (using 2.5th and 97.5th percentile).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
FDA 510(k) Clearance Letter - Cystatin C Test System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 16, 2025
SENTINEL CH. S.p.A.
Patricia Dupé
Head of Quality System
Via Robert Koch, 2
Milan (MI), 20152, Italy
Re: K242585
Trade/Device Name: Cystatin C
Regulation Number: 21 CFR 862.1225
Regulation Name: Creatinine Test System
Regulatory Class: Class II
Product Code: NDY
Dated: April 10, 2025
Received: April 10, 2025
Dear Patricia Dupé
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K242585 - Patricia Dupé Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K242585 - Patricia Dupé Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D.
Deputy Director
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K242585
Device Name
Cystatin C
Indications for Use (Describe)
The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system.
Measurement of cystatin C aids in the diagnosis and treatment of renal diseases.
For laboratory professional use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
SENTINEL CH. SpA
Assay Name: Cystatin C
Traditional 510(k)
Administrative Documentation – 510(k) Summary Page 1 of 12
Administrative Documentation – 510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
I. 510(k) Number
II. Applicant Name
SENTINEL CH. S.p.A.
Via Robert Koch, 2
Milano (MI)
20152, Italy
+39 02 345 514 1
Primary contact person for all communications:
Patricia Dupé
Head of Quality System
Phone: +39 02 34 551 496
Fax: +39 02 34 551 464
Email: patriciadupe@sentinel.it
Secondary contact person for all communications:
Alessia Moiana
Sr. Regulatory Affairs Specialist
Phone: +39 02 34 551 494
Email: alessiamoiana@sentinel.it
Date Summary Prepared: May 15, 2025
III. Device Name and Classification
Trade name: Cystatin C
Device Classification: Class II
Regulation Description: Creatinine test system
Regulation Number: 862.1225
Product Code: NDY
Page 6
SENTINEL CH. SpA
Assay Name: Cystatin C
Traditional 510(k)
Administrative Documentation – 510(k) Summary Page 2 of 12
IV. Predicate Device
Tina-quant Cystatin C Gen.2 (K161817)
V. Description of Device
A. Principles of the Procedure
The Cystatin C assay is an automated clinical chemistry assay.
Cystatin C is a particle-enhanced turbidimetric immunoassay (PETIA) developed to accurately and reproducibly measure cystatin C levels in serum and plasma. Latex particles coated with anti-human cystatin C antibody agglutinate when mixed with sample containing human cystatin C. The change in absorbance due to agglutination of the reaction mixture is proportional to the quantity of human cystatin C in the sample.
Assay standardization
The Cystatin C assay on Alinity c system is aligned to the certified reference material ERM-DA471/IFCC.
The Cystatin C Calibrators are manufactured gravimetrically and are referenced to European Reference Material ERM-DA471/IFCC at each concentration level.
B. Reagent
The various configurations of the Cystatin C for Alinity c Reagent Kit are described below.
| List Number | 06T3220 | 06T3230 |
|---|---|---|
| Tests per cartridge | 100 | 250 |
| Number of cartridges per kit | 2 | 2 |
| Tests per kit | 200 | 500 |
| Reagent (R1) | 20.8 mL | 46.5 mL |
| Reagent (R2) | 7.5 mL | 13.7 mL |
Page 7
SENTINEL CH. SpA
Assay Name: Cystatin C
Traditional 510(k)
Administrative Documentation – 510(k) Summary Page 3 of 12
Volumes (mL) listed in the table above indicate the volume per cartridge.
Each Cystatin C cartridge contains 2 ready to use liquid reagents (R1 and R2).
| Active Ingredients | Concentration |
|---|---|
| Reagent 2: latex particles coated with rabbit IgG against human cystatin C | 0.09% |
Inactive ingredients:
Reagent 1: buffer and stabilizers. Preservative: sodium azide ( 80 (mL/min/1.73 m²). The age of the study population ranged from 18 to 69 years.
The reference range using the 2.5th and 97.5th percentile is summarized below.
| Range (mg/L) | |
|---|---|
| Adult | 0.59–1.28 |
IX. Summary of Clinical Performance
This section does not apply.
X. Conclusion
The information presented in this 510(k) premarket notification demonstrate that the performance of the subject device, Cystatin C for use with Alinity c system (List Number 06T32), is substantially equivalent to the predicate device, Tina-quant Cystatin C Gen.2 (K161817).
The minor differences between predicated device and candidate device raise no new issues of safety and effectiveness and do not impact the indications for use or technological characteristics.
- Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition. CLSI document EP28-A3c. Wayne, PA: CLSI; 2008.