(95 days)
Not Found
No
The summary describes a standard in-vitro diagnostic assay using turbidimetry on a clinical chemistry analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in-vitro diagnostic assay used to measure Cystatin C levels, 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 in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases," which directly indicates a diagnostic purpose. The device is also referred to as "in-vitro diagnostic determination" throughout the document.
No
The device is an in-vitro diagnostic reagent kit (Cystatin C, Calibrator, and Control) used with a specific clinical chemistry analyzer (T60). This involves physical components (reagents) and a hardware analyzer, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "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."
- Purpose: The device is used to analyze biological samples (serum and plasma) outside of the human body to provide information for the diagnosis and treatment of a medical condition (renal diseases).
- Components: The description includes components like a calibrator and controls, which are typical for IVD assays used to ensure the accuracy and reliability of the test results.
The information provided strongly indicates that this device falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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
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
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
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
Product codes (comma separated list FDA assigned to the subject device)
NDY, JJX, JIT
Device Description
Not Found
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
1-50 years of age, >50 years of age
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:
Within run:
Level 0.70 mg/L, SD = 0.010, CV(%) = 1.4
Level 1.49 mg/L, SD = 0.039, CV(%) = 2.6
Cystatin C Control 1.03 mg/L, SD = 0.028, CV(%) = 2.7
Cystatin C High Control 4.59 mg/L, SD = 0.054, CV(%) = 1.2
Between run:
Level 0.70 mg/L, SD = 0.011, CV(%) = 1.5
Level 1.49 mg/L, SD = 0.006, CV(%) = 0.4
Cystatin C Control 1.03 mg/L, SD = 0.032, CV(%) = 3.1
Cystatin C High Control 4.59 mg/L, SD = 0.038, CV(%) = 0.8
Total:
Level 0.70 mg/L, SD = 0.016, CV(%) = 2.3
Level 1.49 mg/L, SD = 0.038, CV(%) = 2.6
Cystatin C Control 1.03 mg/L, SD = 0.044, CV(%) = 4.2
Cystatin C High Control 4.59 mg/L, SD = 0.074, CV(%) = 1.6
Method Comparison:
y = 0.94x + 0.091
r = 0.9988
Range 0.21 to 6.58 mg/L
n = 54
Limitations:
Lipemia: No interference found up to 800 mg/dL of Intralipid™ (trademark of Fresenius Kabi AB), No interference found up to 1500 mg/dL of triglycerides
Hemoglobin: No interference found up to 1000 mg/dL of hemoglobin in hemolysate
Bilirubin, conjugated: No interference found up to 58.5 mg/dL of conjugated bilirubin
Bilirubin, unconjugated: No interference found up to 58.5 mg/dL of unconjugated bilirubin
Rheumatoid factor: No interference was found up to Not specified
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.
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
§ 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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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
1
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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 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
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
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
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
3
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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 the | |
| quantitative determination of the | ||
| Cystatin C concentration in human | ||
| serum, Li-heparin plasma and | ||
| EDTA plasma on T60 analyzer. | Cystatin C Immunoparticles | |
| are intended for the | ||
| quantitative determination of | ||
| cystatin C in human serum, | ||
| heparinized plasma and EDTA | ||
| plasma by turbidimetry and | ||
| nephelometry. Cystatin C | ||
| measurements are used as an | ||
| aid in the diagnosis and | ||
| treatment of renal diseases. | ||
| Indication 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 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 Immunoparticles are | |
| intended for the quantitative | ||
| determination of cystatin C in | ||
| human serum, heparinized | ||
| plasma and EDTA plasma by | ||
| turbidimetry and nephelometry. | ||
| Cystatin C measurements are | ||
| used as an aid in diagnosis and | ||
| treatment of renal diseases. | ||
| Assay Protocol | Particle enhanced | |
| immunoturbidimetric | Particle enhanced | |
| immunoturbidimetric | ||
| Traceability/Standardi | ||
| zation | The value of Cystatin C has been | |
| assigned by using a precise | ||
| transfer protocol ensuring | ||
| traceability to a pure recombinant | ||
| Cystatin C preparation, where the | ||
| Cystatin C concentration was | ||
| established by dry mass | ||
| determination. | The value of Cystatin C has been | |
| assigned by using a precise | ||
| transfer protocol ensuring | ||
| traceability to a pure recombinant | ||
| Cystatin C preparation, where the | ||
| Cystatin C concentration was | ||
| established by dry mass | ||
| determination. | ||
| Sample Type | Human serum, Li-heparin plasma | |
| and EDTA plasma | Human serum, heparinized | |
| plasma 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/L | ||
| Individuals >50 years of age: | ||
| 0.63-1.44 mg/L | Individuals 1-50 years of age: | |
| 0.55-1.15 mg/L | ||
| Individuals >50 years of age: | ||
| 0.63-1.44 mg/L | ||
| Instrument | T60 and DPC T60i, DPC T60i | |
| Kusti | Hitachi 911, Hitachi 917, Cobas | |
| Mira 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 run | |
| Level 0.70 mg/L | ||
| SD = 0.010 | ||
| CV(%) = 1.4 | ||
| Level 1.49 mg/L | ||
| SD = 0.039 | ||
| CV(%) = 2.6 | ||
| Cystatin C Control | ||
| 1.03 mg/L | ||
| SD = 0.028 | ||
| CV(%) = 2.7 | ||
| Cystatin C High Control | ||
| 4.59 mg/L | ||
| SD = 0.054 | ||
| CV(%) = 1.2 | Results obtained on Hitach | |
| following the NCCLS EP5- | ||
| Between run | ||
| Level 0.70 mg/L | ||
| SD = 0.011 | ||
| CV(%) = 1.5 | ||
| Level 1.49 mg/L | ||
| SD = 0.006 | ||
| CV(%) = 0.4 | ||
| Cystatin C Control | ||
| 1.03 mg/L | ||
| SD = 0.032 | ||
| CV(%) = 3.1 | ||
| Cystatin C High Control | ||
| 4.59 mg/L | ||
| SD = 0.038 | ||
| CV(%) = 0.8 | Total | |
| Cystatin C Control 1 | ||
| CV(%) = 2.1 | ||
| Cystatin C Control 2 | ||
| CV(%) = 2.6 | ||
| Human Serum Pool Low | ||
| CV(%) = 5.9 | ||
| Human Serum Pool Medium | ||
| CV(%) = 2.0 | ||
| Human Serum Pool High | ||
| CV(%) = 2.3 | ||
| Total | ||
| Level 0.70 mg/L | ||
| SD = 0.016 | ||
| CV(%) = 2.3 | ||
| Level 1.49 mg/L | ||
| SD = 0.038 | ||
| CV(%) = 2.6 | ||
| Cystatin C Control | ||
| 1.03 mg/L | ||
| SD = 0.044 | ||
| CV(%) = 4.2 | ||
| Cystatin C High Control | ||
| 4.59 mg/L | ||
| SD = 0.074 | ||
| CV(%) = 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/L | ||
| n = 54 | Dade Behring N Latex Cystatin | |
| C Test Kit | ||
| Dade Behring Prospec | ||
| Nephelometer | ||
| Heparinized plasma samples: | ||
| $y = 0.6954x + 0.214$ | ||
| $r = 0.9865$ | ||
| n = 190 | ||
| Limitations | Lipemia: | |
| No interference found up to 800 | ||
| mg/dL of Intralipid™ (trademark | ||
| of Fresenius Kabi AB) | ||
| No interference found up to 1500 | ||
| mg/dL of triglycerides | ||
| Hemoglobin: | ||
| No interference found up to 1000 | ||
| mg/dL of hemoglobin in | ||
| hemolysate | ||
| Bilirubin, conjugated: | ||
| No interference found up to | ||
| 58.5 mg/dL of conjugated bilirubin | ||
| Bilirubin, unconjugated: | ||
| No interference found up to | ||
| 58.5 mg/dL of unconjugated | ||
| bilirubin | ||
| Rheumatoid factor: | ||
| No interference was found up to | Triglyceride | |
| No interference was found for | ||
| triglyceride up to 15 g/L (1500 | ||
| mg/dL) | ||
| Hemoglobin | ||
| No interference was found for | ||
| hemoglobin up to 10 g/L (1000 | ||
| mg/dL) | ||
| Bilirubin, conjugated | ||
| No interference was found for | ||
| conjugated bilirubin up to 600 | ||
| mg/L (60 mg/dL) | ||
| Bilirubin, nonconjugated | ||
| No interference was found for | ||
| nonconjugated bilirubin up to | ||
| 600 mg/L (60 mg/dL) | ||
| Rheumatoid factor | ||
| No interference was found for | ||
| rheumatoid factor up to 1200 | ||
| IU/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
4
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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
5
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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
:
.
6
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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).
7
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
8
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.
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.
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) | |
|---|---|
| Vision Sign-Off | |
| Page 1 of 1 | |
| In Vitro Diagnostic Device | |
| K063647 |
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