K Number

Device Name

DIAZYME CYSTATIN C POC TEST KIT

Manufacturer

DIAZYME LABORATORIES

Date Cleared

2012-03-30

(290 days)

Product Code

NDY JJX

Regulation Number

862.1225

Intended Use

Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART analyzer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only. The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

Device Description

Diazyme Cystatin C POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Cystatin C (Cys C) in human venous whole blood samples. Measurement of Cystatin C can assist in the assessment of renal transplantation status, monitoring GFR in nephrotoxic drug therapy, and monitoring GFR in acute and chronic kidney diseases including diabetic nephropathy. Cystatin C POC Test reagents are similar to the predicate Diazyme Cystatin C assay reagents (k093680). The similarities and differences in composition and format are noted in Table 1 below. The Cystatin C POC Test is based on a latex enhanced immunoturbidimetric assay. Cystatin C in the venous whole blood sample binds to the specific anti-Cystatin C antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Cystatin C in the venous whole blood sample. The Cystatin C concentration is expressed as mg/L Cystatin C by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit. Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Diazyme Cystatin C POC Test and is packaged separately. The controls are made from human venous whole blood and are in a lyophilized (freeze-dried) state. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. SMART Analyzer (k092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuyette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for venous whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093680, K092911

Reference Devices

K093680, K092911

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a standard immunoturbidimetric assay and spectrophotometric analysis, with no mention of AI or ML algorithms for data processing or interpretation. The calibration curve is stored on an RFID card, indicating a pre-defined, non-adaptive method.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of Cystatin C, which serves as an aid in the diagnosis and treatment of renal disease, rather than directly treating the disease itself.

Diagnostic

Yes

Explanation: The "Intended Use" section states that the measurement of Cystatin C is "used as an aid in the diagnosis and treatment of renal disease." This explicitly indicates a diagnostic purpose for the device.

SaMD (Software as a Medical Device)

The device description explicitly states that the Diazyme Cystatin C POC Test Kit contains reagents and is intended for use with the SMART analyzer, which is described as a compact cuvette based spectrophotometer (hardware). The device is a system that includes both reagents and hardware, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use Statement: The document explicitly states "For in vitro Diagnostic Use Only" for both the test reagents and the control kit.
Measurement of Biomarker: The device measures Cystatin C in a biological sample (venous whole blood).
Aid in Diagnosis and Treatment: The intended use is to aid in the diagnosis and treatment of renal disease.
Analysis of Biological Samples: The device analyzes human venous whole blood samples.
Device Description: The description details the reagents, controls, and analyzer used to perform the test on a biological sample.

All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

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

NDY, JJX

Device Description

Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Diazyme Cystatin C POC Test and is packaged separately. The controls are made from human venous whole blood and are in a lyophilized (freeze-dried) state. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.

SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuyette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette and caps are supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for venous whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

The Diazyme Cystatin C POC Test system thus consists of the following:

Cystatin C POC Test Kit. Reagents are provided in prefilled tubes, cuvettes . and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
Cystatin C POC Test Control Kit. Controls are provided for quality control of . the Cystatin C POC Test.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:
The precision of the Diazyme Cystatin C POC Test was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline. Three whole blood specimens containing 1.00 mg/L, 2.70 mg/L, and 6.20 mg/L Cystatin C were tested in 2 runs per day with duplicates over 10 working days on three different SMART Analyzers.

	Whole blood 1 Cystatin C	Whole blood 2 Cystatin C	Whole blood 3 Cystatin C	Whole blood 4 Cystatin C	Whole blood 5 Cystatin C	Whole blood 6 Cystatin C
Total data points	40	40	40	40	40	40
Mean ( mg/L)	0.988	2.720	6.1305	0.696	1.217	4.717
SD ( mg/L)	0.0553	0.0694	0.1353	0.0444	0.0563	0.1148
CV mg/L	5.6%	2.6%	2.2%	6.4%	4.6%	2.4%

Linearity/Reportable Range:
Eleven levels of the Cystatin C linearity set were prepared by diluting a whole blood containing about 8 mg/L Cystatin C with saline according to CLSI EP6-A and then were run with Diazyme Cystatin C POC Test Kit in triplicates. After linear regression. the correlation coefficient is R2 = 0.9977. slope is 0.9643, and y intercept is -0.0456. Diazyme Cystatin C POC Test Kit is linear up to 7.65 mg/L. Analytical measuring range (AMR) is 0.30-7.65mg/L.

LoB, LoD, LoQ:
The LOB. LOD and LOQ of Diazyme Cystatin C POC Test Kit were determined according to CLSI EP17-A. LOB = 0.045 mg/L; LOD = 0.11 mg/L; LOQ = 0.30 mg/L Cystatin C.

Analytical specificity - Interference Study:
Common interfering substances had no significant interference up to the concentrations summarized below:

Interference	Concentration
Triglyceride	1000 mg/dL
Ascorbic Acid	10 mg/dL
Bilirubin	40 mg/dL
Bilirubin Conjugated	40 mg/dL
Rheumatoid Factor	1000 IU/mL
Hemoglobin	10.0 g/dL

Method comparison with predicate device - Internal method comparison:
Paired human whole blood-serum samples (venous whole blood and plasma from the same individual) were tested for comparison. The whole blood samples were tested with the Diazyme Cystatin C POC Test on SMART analyzer and the correspondent plasma samples were tested with predicate Assay (K093680) on Hitachi 917. A total of fifty five (55) EDTA whole blood specimens were tested with Diazyme Cystatin C POC Test. The correspondent plasma samples were tested with Diazyme Cystatin C on Hitachi 917 analyzer.
N = 55
Slope = 0.9535
Intercept = 0.0958
R2 = 0.9867

Method comparison with predicate device - External method comparison:
120 whole blood samples were tested at three POL sites by intended users. Each site ran 40 whole blood samples using SMART analyzers. The corresponding one hundred and twenty (120) plasma specimens were tested on Hitachi 917 with predicate device.

	Site 1	Site 2	Site 3	All 3 sites
N	40	40	40	120
Slope	0.9967	0.9049	0.9617	0.955
Intercept	0.1058	0.0731	0.0352	0.0723
R2	0.9902	0.9902	0.9937	0.9872

Expected values/ Reference range:
Whole blood samples from 126 apparently healthy adults with age of 19-63 were tested. The expected normal range is 0.46 to 1.06 mg/L in 95% of the population tested.

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.

K093680, K092911

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

Pre-market notification Diazyme Cystatin C POC Test

MAR 3 0 2012 K111664

510(k) SUMMARY

Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Submitter's name:	Diazyme Laboratories
Submitter's address:	12889 Gregg Court
Poway, CA 92064
USA
Name of Contact Person:	Dr. Abhijit Datta
Diazyme Laboratories
12889 Gregg Court
Poway, CA 92064
	Phone: 858-455-4762
Fax: 858-455-2120
abhijit.datta@diazyme.com
Name of the Device	Cystatin C POC Test; Cystatin POC Test Control Kit
Trade Name	Cystatin C POC Test; Cystatin POC Test Control Kit
Common Usual Name	SMART Cystatin C Assay
Device Classification Name	Cystatin C POC Assay
Product Code	NDY; Test, Cystatin C JJX;
Quality Control Material
Panel	Clinical Chemistry (75)
Submission Type	510K
Regulation Number	21CFR 862.1225, Creatinine Test System
21CFR 862.1660, Quality Control Material
Device Class	Class II (Assay)
Class I (Control)
Predicate Device	Diazyme Cystatin C Assay
K093680, K092911
Establishment Registration	2032900

Executive Summary

Detailed performance characteristics and comparison analysis are given in this filing that demonstrates substantial equivalence of the Cystatin C POC Test Kit to predicate device that is currently being marketed. The performance characteristics of the Cystatin C POC Test Kit are substantially similar to that of the approved predicate device (K093680). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Cystatin C POC Test and offers POL users an in vitro diagnostic device system to measure Cystatin C in human blood samples.

Device Description:

SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuyette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for venous whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

The Diazyme Cystatin C POC Test system thus consists of the following:

Cystatin C POC Test Kit. Reagents are provided in prefilled tubes, cuvettes . and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
Cystatin C POC Test Control Kit. Controls are provided for quality control of . the Cystatin C POC Test.

Equipment needed for Diazyme Cystatin C POC Test:

SMART Analyzer (K092911). .

Indication (s) for Use:

The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

| Summary of Assay Kit Components

(Candidate device)
Reagent 1
20 DRS cuvette (prefilled)
100 mM TrisCl buffer, 0.125% triton
Reagent 2
20 DRS caps (prefilled)
Suspension of anti-human Cystatin C polyclonal antibody coated latex particles ( Trade Name: Diazyme Cystatin C POC Test Kit; Diazyme Cystatin C POC Test Control Kit Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY, JJX Dated: March 15, 2012

Received: March 19, 2012

Dear Dr. Datta:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (If Known): K111664

Device Name: Diazyme Cystatin C POC Test Kit; Diazyme Cystatin C POC Test Control Kit

Indications for Use:

Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART ana-Draer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only.

The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or

Over-The-Counter Use (21 CFR 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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

KIII KKU 210(K)

Page 1 of