(252 days)
Not Found
No
The summary describes a standard in-vitro diagnostic assay for creatinine measurement using a clinical chemistry analyzer. There is no mention of AI, ML, or any computational analysis beyond basic quantitative calculations and statistical analysis of performance data.
No
The device is an in-vitro diagnostic assay for measuring creatinine levels, which aids in diagnosis and monitoring, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for quantitative in-vitro diagnostic determination of creatinine concentration" and that "Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis". This clearly indicates its use in the diagnosis of medical conditions.
No
The device is an in-vitro diagnostic reagent kit (CREATININE (Enzymatic), sCal, Nortrol, Abtrol) used with a specific clinical chemistry analyzer (T60). These are physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine..."
- "sCal: For in vitro diagnostic use on T60 analyzer."
- "Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer."
- "Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer."
These statements clearly indicate that the device and its associated components (calibrator and controls) are intended for use in testing biological samples outside of the body to aid in diagnosis and treatment.
N/A
Intended Use / Indications for Use
CREATININE (Enzymatic):
For in vitro diagnostic use in the quantitative determination of creatinine concentration in human serum, plasma or urine on T60 instrument using enzymatic method.
The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease,in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
sCal:
For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol:
For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol:
For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIX, JJY
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
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 (Serum/plasma):
- Within run:
- Level 0.43 mg/dL: SD= 0.006, CV(%)= 1.5
- Level 1.75 mg/dL: SD=0.008, CV(%)=0.4
- Level 5.47 mg/dL: SD= 0.021, CV(%)=0.4
- Between run:
- Level 0.43 mg/dL: SD= 0.002, CV(%)=0.4
- Level 1.75 mg/dL: SD=0.008, CV(%)=0.5
- Level 5.47 mg/dL: SD= 0.015, CV(%)=0.3
- Total:
- Level 0.43 mg/dL: SD= 0.009, CV(%)=2.2
- Level 1.75 mg/dL: SD= 0.026, CV(%)= 1.5
- Level 5.47 mg/dL: SD= 0.076, CV(%)= 1.4
Precision (Urine):
- Within run:
- Level 76 mg/dL: SD= 0.7, CV(%)= 1.0
- Level 90 mg/dL: SD= 0.8, CV(%)=0.8
- Level 165 mg/dL: SD= 1.4, CV(%)=0.9
- Level 251 mg/dL: SD= 2.2, CV(%)=0.9
- Between run:
- Level 76 mg/dL: SD= 0.6, CV(%)=0.8
- Level 90 mg/dL: SD= 0.4, CV(%)=0.5
- Level 165 mg/dL: SD= 1.9, CV(%)= 1.2
- Level 251 mg/dL: SD= 2.3, CV(%)=0.9
- Total:
- Level 76 mg/dL: SD= 2.7, CV(%)= 3.5
- Level 90 mg/dL: SD= 2.8, CV(%)= 3.1
- Level 165 mg/dL: SD= 5.7, CV(%)= 3.5
- Level 251 mg/dL: SD= 8.7, CV(%)= 3.5
Method Comparison (with Roche/Hitachi 917 analyzer):
- Serum:
- y = 1.01x - 0.001
- R = 1.000
- Range 0.12 to 24 mg/dL
- N = 41
- Plasma:
- Deming: y = 0.97 - 0.02
- r = 1.000
- Range 0.27 to 27.58 mg/dL
- N = 52
- Urine:
- y = 1.03x + 1.34
- R = 0.999
- Range 2.33 to 422 mg/dL
- N = 135
Limitations (Interference Studies):
- Serum/plasma:
- Lipemia: No interference up to 1000 mg/dL (10 g/l) of Intralipid.
- Hemolysate: No interference up to 1000 mg/dL (10 g/l) of hemoglobin.
- Bilirubin, conjugated: No interference up to 17 mg/dL (300 µmol/l).
- Bilirubin, unconjugated: No interference up to 23 mg/dL (400 µmol/l).
- Ascorbic acid: No interference up to 1.70 mmol/L (30 mg/dL).
- Creatine: No interference up to 1.53 mmol/L (20 mg/dL).
- Drugs: Levodopa and calcium dobesilate cause artificially low creatinine levels.
- Urine:
- Hemolysate: No interference up to 1000 mg/dL (10 g/l) of hemoglobin.
- Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l).
- Glucose: No interference up to 2500 mg/dL (139 mmol/l).
- Ascorbic acid: No interference up to 100 mg/dL (5.7 mmol/l).
- Drugs: Levodopa causes artificially low results.
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
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: K070824_
A. Introduction:
DEC 03 2007
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.
| B. | Submitter's information | |
|---|---|---|
| Name: | Thermo Fisher Scientific Oy | |
| 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: | October 16th, 2007 | |
| C. | Device name | |
| Proprietary name: | CREATININE (Enzymatic), code 981845 | |
| Common name: | CREATININE (Enzymatic) | |
| Classification: | Clinical Chemistry | |
| Class: | II | |
| Product Code: | JFY | |
| Proprietary name: | sCal, code 981831 | |
| Common Name: | Calibrator, Multi-Analyte Mixture | |
| Classification: | Clinical Chemistry | |
| Class: | II | |
| Product Code: | JIX | |
| Proprietary name: | Nortrol, code 981043 | |
| Common Name: | Multi-analyte Controls (Assayed and unassayed) | |
| Classification: | Clinical Chemistry | |
| Class: | I | |
| Product Code: | JJY | |
| Proprietary name: | Abtrol, code 981044 | |
| Common Name: | Multi-analyte Controls (Assayed and unassayed) | |
| Classification: | Clinical Chemistry | |
| Class: | I | |
| Product Code: | JJY |
Thermo Fisher Scientific 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
D. Intended Use
CREATININE (Enzymatic).
For in vitro diagnostic use in the quantitative determination of creatinine concentration in human serum, plasma or urine on T60 instrument using enzymatic method
sCal
For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol
For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol
For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Thermo Fisher Scientific 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
2
E. Indications for use
The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease,in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
For sCal Calibrator, Nortrol and Abtrol Controls see intended use
F. Substantial Equivalence
Roche Diagnostics Corporation, model COBAS Integra 700 Roche Diagnostics Corporation item: COBAS Integra Creatinine plus ver.2 (K024098).
G. Substantial equivalence -similarities
CREATININE (Enzymatic) is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Roche Diagnostics Corporation COBAS Integra Creatinine plus ver.2.
Thermo Fisher Scientific 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 F109215470 Domicile Helsinki
3
| Intended Use | For in vitro diagnostic use in the quantitative determination of creatinine concentration in human serum, plasma or urine on T60 instrument using enzymatic method. | The cassette COBAS INTEGRA Creatinine plus ver.2 (CREAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma and urine. |
|---|---|---|
| Indication for Use | The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. | See intended use. |
| Assay Protocol | Enzymatic colorimetric assay | Enzymatic colorimetric assay |
| Traceability/Standardization | The value of Creatinine has been assigned by using NIST SRM 967 (for serum) and NIST SRM 914a (for urine) | Method has been standardized against ID/MS |
| Sample Type | Serum, plasma (Li-heparin) and urine | Serum, plasma (Li-heparin, K3-EDTA) and urine |
| Reagent Storage | Reagents in unopened vials are stable at 2...8 °C until the expiry date printed on the label. | Shelf life at 2 to 8 °C until the expiration date on cassette. |
The following table compares the CREATININE (Enzymatic) with the predicate device. Table 1
Thermo Fisher Scientific Oy
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
4
| Expected Values | ||
|---|---|---|
| Serum/plasma | ||
| Male: 0.67 – 1.17 mg/dL | ||
| Female: 0.51 – 0.95 mg/dL |
Urine
Male: 40 – 278 mg/dL
Female: 29 – 226 mg/dL | Serum, plasma:
Adults
Females: 0.51 – 0.95 mg/dL
Males: 0.67 – 1.17 mg/dL
Children
Neonates (premature): 0.33 – 0.98 mg/dL
Neonates (full term): 0.31 – 0.88 mg/dL
2 - 12 m: 0.16 – 0.39 mg/dL
1 -
1mmol/L causes falsely high
results.
Other:
No significant interference up
to a creatine level of 1.53
mmol/L (20 mg/dL) |
| | Urine:
Hemolysate:
No interference found up to 1000
mg/dL (10 g/l) of hemoglobin.
Bilirubin, conjugated:
No interference found up to 58
mg/dL (1000 $\mu$ mol/l) of
conjugated bilirubin.
Glucose:
No interference found up to 2500
mg/dL (139 mmol/l).
Ascorbic acid:
No interference found up to 100
mg/dL (5.7 mmol/l).
Drugs:
Levodopa causes artificially low
results. | Urine:
Drugs:
Levodopa causes artificially
low results
Other:
No significant interference up
to a creatine level of 3.05
mmol/L (40 mg/dL) |
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
FilN-01621 Vantaa
Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 3 2007
Thermo Fisher Scientific c/o Mr. Päivi Sormunen Vice President of Industrial Solutions and ORC Ratastie 2, P.O. Box 100 01621 Vantaa, Finland
Re: K070824
Trade Name: Creatinine (enzymatic): sCal; Nortrol; Abtrol Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: JFY, JIX, JJY Dated: October 23, 2007 Received: October 25, 2007
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, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
9
Page 2 --
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 1egally marketed predicate device results in a classification for your device and thus, perroits 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.
Sean 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
10
Indication for Use
510(k) Number (if known): K070824
Device Name: CREATININE (Enzymatic) sCal Nortrol Abtrol
Indication For Use:
Creatinine (Enzymatic)
The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
sCal
For in vitro diagnostic use on T60 analyzer.
sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
| Prescription Use
(21 CFR Part 801 Subpart D) | And/Or | Over the Counter Use _
(21 CFR Part 801 Subpart C) |
|-------------------------------------------------|--------|-------------------------------------------------------|
| X | | . |
(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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070824