Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma by turbidimetry using T60 Clinical Chemistry Analyzers.

Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases.

Cystatin C Calibrator is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Calibrator is used as a calibrator for quantification of Cystatin C in serum and plasma by immunoturbidimetry using methods defined by Thermo Electron Oy.

Cystatin C Control is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control is used as a quality control to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.

Cystatin C Control High is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control High is used as a quality control serum to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.

Device Description

Not Found

AI/ML Overview

The provided text describes the 510(k) summary for the Thermo Electron Oy CYSTATIN C diagnostic kit. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study to meet acceptance criteria for a novel device. However, some performance characteristics are reported that can be considered as addressing acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated for individual metrics. Instead, the approach is to demonstrate comparability to a legally marketed predicate device (Dako Cystatin C reagent). The document outlines several performance characteristics, and the implicit acceptance criterion is that the new device's performance should be similar or equivalent to the predicate device.

Performance Attribute	Acceptance Criteria (Implicit - based on predicate)	Reported New Device Performance (Thermo Electron Oy CYSTATIN C)
Intended Use	Quantitative determination of Cystatin C in human serum, heparinized plasma, and EDTA plasma by turbidimetry and nephelometry; aid in diagnosis and treatment of renal diseases.	Quantitative determination of Cystatin C in human serum, Li-heparin plasma, and EDTA plasma on T60 analyzer; aid in diagnosis and treatment of renal diseases.
Assay Protocol	Particle enhanced immunoturbidimetric	Particle enhanced immunoturbidimetric
Traceability/Standardization	Traceability to pure recombinant Cystatin C preparation by dry mass determination.	Traceability to pure recombinant Cystatin C preparation by dry mass determination.
Sample Type	Human serum, heparinized plasma, EDTA plasma	Human serum, Li-heparin plasma, EDTA plasma
Reagent Storage	Store at 2°C - 8°C.	Store at 2°C - 8°C.
Expected Values	Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L	Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L
Measuring Range	~0.4-7.5 mg/L	0.44 - 7.0 mg/L
Precision (Within run, CV%)	Predicate provides total CV% ranges from 2.1% to 5.9%	Level 0.70 mg/L: 1.4%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 2.7%; Cystatin C High Control: 1.2%
Precision (Between run, CV%)	Predicate provides total CV% ranges from 2.1% to 5.9%	Level 0.70 mg/L: 1.5%; Level 1.49 mg/L: 0.4%; Cystatin C Control: 3.1%; Cystatin C High Control: 0.8%
Precision (Total, CV%)	Predicate provides total CV% ranges from 2.1% to 5.9%	Level 0.70 mg/L: 2.3%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 4.2%; Cystatin C High Control: 1.6%
Method Comparison (Correlation with Predicate)	High correlation (e.g., r ≥ 0.98), slope close to 1, intercept close to 0.	$y = 0.94x + 0.091$, $r = 0.9988$ (Range 0.21 to 6.58 mg/L, n = 54)
Interferences (Lipemia)	No interference up to 1500 mg/dL triglycerides.	No interference up to 800 mg/dL Intralipid™; No interference up to 1500 mg/dL triglycerides.
Interferences (Hemoglobin)	No interference up to 1000 mg/dL.	No interference up to 1000 mg/dL.
Interferences (Bilirubin, conjugated)	No interference up to 60 mg/dL.	No interference up to 58.5 mg/dL.
Interferences (Bilirubin, unconjugated)	No interference up to 60 mg/dL.	No interference up to 58.5 mg/dL.
Interferences (Rheumatoid factor)	No interference up to 1200 IU/mL.	No interference was found up to (value truncated in document).

2. Sample size used for the test set and the data provenance

Method Comparison: n = 54 samples were used for the method comparison study with the predicate device.
Precision: The sample sizes for the precision studies (within-run, between-run, total) are not explicitly stated, but results are given for specific "Levels" (e.g., 0.70 mg/L, 1.49 mg/L) and "Controls" (Cystatin C Control, Cystatin C High Control). Typically, precision studies involve running multiple replicates of these samples over several days/runs.
Interference: No specific sample size is given for interference studies, but it's implied that studies were performed to determine the interference limits for various substances.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address is Finland, the studies were likely conducted there or in collaboration with Finnish institutions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the true concentration of Cystatin C in the samples. This is usually established through highly accurate reference methods or certified reference materials, not by expert consensus in the same way an imaging device might use radiologists. The document mentions traceability to "a pure recombinant Cystatin C preparation, where the Cystatin C concentration was established by dry mass determination," which serves as the ultimate reference for ground truth in this context.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation (e.g., medical imaging) where human experts determine a "ground truth" or categorize findings. For a quantitative diagnostic like Cystatin C measurement, the ground truth is established analytically (e.g., precise reference methods, dry mass determination).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an in vitro diagnostic assay kit for measuring Cystatin C concentration, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex, multi-case scenarios.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this is a standalone device (algorithm only). The "algorithm" here refers to the immunoassay method itself and the T60 analyzer's processing of samples to yield a quantitative result. There is no human-in-the-loop performance component in the direct measurement process; the device outputs a quantitative value.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the Cystatin C calibrator and potentially other samples is established by traceability to a pure recombinant Cystatin C preparation, with its concentration determined by dry mass determination. This is a highly precise analytical method, serving as the "true" concentration for calibration and validation.

8. The sample size for the training set

This information is not provided. The document describes a traditional immunoassay, not a machine learning model, so the concept of a "training set" for an algorithm in the AI sense is not directly applicable. However, analytical studies for establishing assay parameters (e.g., linearity, sensitivity, specificity) would involve a range of samples and controls, but these are not explicitly termed a "training set" here.

9. How the ground truth for the training set was established

As noted above, a "training set" in the AI sense is not directly applicable. However, the ground truth for calibrators and control materials used in developing and validating the assay would be established through traceability to pure recombinant Cystatin C preparation with concentration determined by dry mass determination, as mentioned for the overall assay's standardization.

Summary

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510(k) SUMMARY

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

The assigned 510(k) number is: K063647

A. Introduction:

According to the requirements of 21 CFR 807.92 the following information provides sufficent detail to understand the basis for a determination of substantial equivalence.

Thermo Electron Oy

B. Submitter's information

Name:
Address:

Address:	Ratastie 2
	P.O. Box 100
	FIN-01621 Vantaa
	Finland
Phone:	+358 (9) 329 100 tel
Fax:	+358 (9) 3291 0500 fax
Contact person:	Päivi Sormunen, Vice President of QRC
Date of Preparation:	December 05, 2006

C. Device name

Proprietary name: Common name: Classification: Class: Product Code: Regulation Number CYSTATIN C, (code 981911) Cystatin C Clinical Chemistry II NDY 21CFR 862.1225

Proprietary name: Common Name: Classification: Class: Product Code: Regulation Number CYSTATIN C CALIBRATOR, (code 981912) Calibrator Clinical Chemistry II JIT 21CFR 862.1150

Proprietary name: Common Name: Classification: Class: Product Code: Regulation Number CYSTATIN C CONTROL, (code 981913) Control (Assayed and unassayed) Clinical Chemistry I

JJX 21CFR 862.1660

Thermo Electron Oy

Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

+358 (9) 329 100 tel +358 (9) 3291 0500 fax

Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.therno.com

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Proprietary name: Common Name: Classification: Class: I Product Code: JJX Regulation Number 21CFR 862.1660

CYSTATIN C CONTROL HIGH, (code 981914) Control (Assayed and unassayed) Clinical Chemistry

D. Intended Use

CYSTATIN C

For in vitro diagnostic use in the quantitative determination of the Cystatin C concentration in human serum, Li-heparin plasma and EDTA plasma on T60 analyzers.

CYSTATIN C CALIBRATOR

CYSTATIN C CONTROL

CYSTATIN C CONTROL HIGH

E. Indications for use

The Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma using T60 Clinical Chemistry Analyzers.

Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases.

For Cystatin C Calibrator, Cystatin C Control and Cystatin C Control High, see intended use

F. Substantial Equivalence

The Cystatin C is substantially equivalent to the Dako Cystatin C reagent (K041627) with respect to indications for use, device design, materials and operational principles. The basic differences between the new device and Dako predicate device are the instruments used for testing. The Dako device can be used on commercially available turbidimetry and nephelometry analyzers, while the T60 device can be used on only T60 analyzers.

Thermo Electron Ov

Ratactie 7 P.O. Box 100 FIN-01621 Vantaa Finland

+358 /0) 270 100 tot +35x 191 1291 0500 fas V - himnus 0971547-0 w. thermo. VAT No FI097 5470

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Substantial equivalence -similarities G.

Cystatin C is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Dako Cystatin C test.

・

Thermo Electron Oy

. ,

Ratastie 2
P.O. Box 100
FIN-01621 Vantaa Finland

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

ww.thermo.com

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The following table compares the Cystatin C with the predicate device.

Table	1

Attribute	New device #1	Predicate device #1
Intented Use	For in vitro diagnostic use in thequantitative determination of theCystatin C concentration in humanserum, Li-heparin plasma andEDTA plasma on T60 analyzer.	Cystatin C Immunoparticlesare intended for thequantitative determination ofcystatin C in human serum,heparinized plasma and EDTAplasma by turbidimetry andnephelometry. Cystatin Cmeasurements are used as anaid in the diagnosis andtreatment of renal diseases.
Indication for Use	Cystatin C is intended forquantitative in-vitro diagnosticdetermination of Cystatin C inhuman serum or Li-heparinplasma and EDTA plasma usingT60 Clinical Chemistry Analyzers.Cystatin C measurements in serumand plasma are used as an aid inthe diagnosis and treatment ofrenal diseases.	Cystatin C Immunoparticles areintended for the quantitativedetermination of cystatin C inhuman serum, heparinizedplasma and EDTA plasma byturbidimetry and nephelometry.Cystatin C measurements areused as an aid in diagnosis andtreatment of renal diseases.
Assay Protocol	Particle enhancedimmunoturbidimetric	Particle enhancedimmunoturbidimetric
Traceability/Standardization	The value of Cystatin C has beenassigned by using a precisetransfer protocol ensuringtraceability to a pure recombinantCystatin C preparation, where theCystatin C concentration wasestablished by dry massdetermination.	The value of Cystatin C has beenassigned by using a precisetransfer protocol ensuringtraceability to a pure recombinantCystatin C preparation, where theCystatin C concentration wasestablished by dry massdetermination.
Sample Type	Human serum, Li-heparin plasmaand EDTA plasma	Human serum, heparinizedplasma and EDTA plasma
Reagent Storage	Store at 2°C - 8°C.	Store at 2°C - 8°C.
Expected Values	Individuals 1-50 years of age:0.55-1.15 mg/LIndividuals >50 years of age:0.63-1.44 mg/L	Individuals 1-50 years of age:0.55-1.15 mg/LIndividuals >50 years of age:0.63-1.44 mg/L
Instrument	T60 and DPC T60i, DPC T60iKusti	Hitachi 911, Hitachi 917, CobasMira Plus and IMMAGE
Measuring Range	0.44 - 7.0 mg/L	~0.4-7.5 mg/L
Attribute	New device #1	Predicate device #1
Precision	Within runLevel 0.70 mg/LSD = 0.010CV(%) = 1.4Level 1.49 mg/LSD = 0.039CV(%) = 2.6Cystatin C Control1.03 mg/LSD = 0.028CV(%) = 2.7Cystatin C High Control4.59 mg/LSD = 0.054CV(%) = 1.2	Results obtained on Hitachfollowing the NCCLS EP5-
	Between runLevel 0.70 mg/LSD = 0.011CV(%) = 1.5Level 1.49 mg/LSD = 0.006CV(%) = 0.4Cystatin C Control1.03 mg/LSD = 0.032CV(%) = 3.1Cystatin C High Control4.59 mg/LSD = 0.038CV(%) = 0.8	TotalCystatin C Control 1CV(%) = 2.1Cystatin C Control 2CV(%) = 2.6Human Serum Pool LowCV(%) = 5.9Human Serum Pool MediumCV(%) = 2.0Human Serum Pool HighCV(%) = 2.3
	TotalLevel 0.70 mg/LSD = 0.016CV(%) = 2.3Level 1.49 mg/LSD = 0.038CV(%) = 2.6Cystatin C Control1.03 mg/LSD = 0.044CV(%) = 4.2Cystatin C High Control4.59 mg/LSD = 0.074CV(%) = 1.6
Attribute	New device #1	Predicate device #1
Method Comparison	$y = 0.94x + 0.091$$r = 0.9988$Range 0.21 to 6.58 mg/Ln = 54	Dade Behring N Latex CystatinC Test KitDade Behring ProspecNephelometerHeparinized plasma samples:$y = 0.6954x + 0.214$$r = 0.9865$n = 190
Limitations	Lipemia:No interference found up to 800mg/dL of Intralipid™ (trademarkof Fresenius Kabi AB)No interference found up to 1500mg/dL of triglyceridesHemoglobin:No interference found up to 1000mg/dL of hemoglobin inhemolysateBilirubin, conjugated:No interference found up to58.5 mg/dL of conjugated bilirubinBilirubin, unconjugated:No interference found up to58.5 mg/dL of unconjugatedbilirubinRheumatoid factor:No interference was found up to	TriglycerideNo interference was found fortriglyceride up to 15 g/L (1500mg/dL)HemoglobinNo interference was found forhemoglobin up to 10 g/L (1000mg/dL)Bilirubin, conjugatedNo interference was found forconjugated bilirubin up to 600mg/L (60 mg/dL)Bilirubin, nonconjugatedNo interference was found fornonconjugated bilirubin up to600 mg/L (60 mg/dL)Rheumatoid factorNo interference was found forrheumatoid factor up to 1200IU/mL

Thermo Electron Oy

Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland

+3$8 (9) 329 100 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

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Thermo Electron Oy

P.O. Box 100
FIN-0162] Vantaa Finland

+358 (9) 3291 0500 fax

1 Kamas 6709215470
Domicile Helsinki

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Thermo Electron Oy

Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland

+358 (9) 329 100 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

www.thermo.com

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paivi Sormunen Thermo Electron Oy Ratastie 2 P.O. Box 100 Vantaa 01621 Finland

MAR 1 2 2007

Re: K063647

Trade/Device Name: Cystatin c antiserum, calibrator, control and control high Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY, JJX, JIT Dated: December 05, 2006 Received: December 15, 2006

Dear Mr. Sormunen:

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, EDA 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).

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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 a legally 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 toll-free 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.

Jean 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

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Indications for Use

510(k) Number (if known): K063647

Device Names:

Cystatin C Cystatin C calibrator Cystatin C control Cystatin C Control High

Indications for Use:

Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma by turbidimetry using T60 Clinical Chemistry Analyzers.

Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of GDRH, Office of In Vitro Diagnostic Devices (OIVD)
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	Page 1 of 1

In Vitro Diagnostic Device

K063647

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.