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.

Device Description

Not Found

AI/ML Overview

This document describes the regulatory submission for a diagnostic device, not an AI/ML powered device. As such, concepts like "AI vs without AI assistance," "standalone performance," or "training set" are not applicable. The information provided focuses on the analytical performance of the Creatinine (Enzymatic) assay and its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on the request, reinterpreting some terms for a diagnostic assay where appropriate:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "CV must be <= X%"). Instead, the performance is demonstrated through comparison with a predicate device and presentation of precision and method comparison data. The implied acceptance criterion for these studies is "comparable to the predicate device" or "within acceptable analytical variability."

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Creatinine Enzymatic)	Predicate Device Performance (COBAS Integra Creatinine plus ver.2)
Precision - Serum/Plasma (Within Run CV%)	Comparable to predicate / Low CV%	Level 0.43 mg/dL: 1.5%Level 1.75 mg/dL: 0.4%Level 5.47 mg/dL: 0.4%	Level 1.0 mg/dL: 1.6%Level 3.7 mg/dL: 0.7%
Precision - Serum/Plasma (Between Run CV%)	Comparable to predicate / Low CV%	Level 0.43 mg/dL: 0.4%Level 1.75 mg/dL: 0.5%Level 5.47 mg/dL: 0.3%	Level 1.0 mg/dL: 1.3%Level 3.8 mg/dL: 0.9%
Precision - Serum/Plasma (Total CV%)	Comparable to predicate / Low CV%	Level 0.43 mg/dL: 2.2%Level 1.75 mg/dL: 1.5%Level 5.47 mg/dL: 1.4%	(Not explicitly stated for total for predicate, but similar magnitude)
Precision - Urine (Within Run CV%)	Comparable to predicate / Low CV%	Level 76 mg/dL: 1.0%Level 90 mg/dL: 0.8%Level 165 mg/dL: 0.9%Level 251 mg/dL: 0.9%	Level 106 mg/dL: 0.8%Level 231 mg/dL: 1.8%
Precision - Urine (Between Run CV%)	Comparable to predicate / Low CV%	Level 76 mg/dL: 0.8%Level 90 mg/dL: 0.5%Level 165 mg/dL: 1.2%Level 251 mg/dL: 0.9%	Level 108 mg/dL: 2.0%Level 238 mg/dL: 3.9%
Precision - Urine (Total CV%)	Comparable to predicate / Low CV%	Level 76 mg/dL: 3.5%Level 90 mg/dL: 3.1%Level 165 mg/dL: 3.5%Level 251 mg/dL: 3.5%	(Not explicitly stated for total for predicate, but similar magnitude)
Method Comparison - Serum (Correlation/Slope/Intercept)	Strong correlation (R/r close to 1), slope close to 1, intercept close to 0.	y = 1.01x - 0.001 (R = 1.000, N=41)	y = 1.01x + 1.13 µmol/l (r = 0.999, n=53)
Method Comparison - Plasma (Correlation/Slope/Intercept)	Strong correlation (R/r close to 1), slope close to 1, intercept close to 0.	Deming: y = 0.97 - 0.02 (r = 1.000, N=52)	(Predicate does not provide separate plasma comparison data, only serum/plasma combined)
Method Comparison - Urine (Correlation/Slope/Intercept)	Strong correlation (R/r close to 1), slope close to 1, intercept close to 0.	y = 1.03x + 1.34 (R = 0.999, N=135)	y = 0.94x + 0.63 mmol/l (r = 0.998, n=54)
Measurement Range - Serum/Plasma	Comparable to predicate	0.11 – 28 mg/dL	0 – 30.5 mg/dL
Measurement Range - Urine	Comparable to predicate	2.3 – 452 mg/dL	0 – 452 mg/dL
Interference - Lipemia	No significant interference up to stated level.	No interference found up to 1000 mg/dL (10 g/l) of Intralipid.	No significant interference up to 1000 mg/dL (triglycerides/Intralipid).
Interference - Hemolysate	No significant interference up to stated level.	Serum: No interference found up to 1000 mg/dL (10 g/l) hemoglobin.Urine: No interference found up to 1000 mg/dL (10 g/l) hemoglobin.	Serum: No significant interference up to 0.50 mmol/L (8 g/l) hemoglobin.
Interference - Bilirubin (conjugated & unconjugated)	No significant interference up to stated level.	Conjugated: Serum up to 17 mg/dL, Urine up to 58 mg/dL.Unconjugated: Serum up to 23 mg/dL.	No significant interference up to 340 µmol/l (20 mg/dL).
Interference - Ascorbic Acid	No significant interference up to stated level.	Serum: No interference found up to 1.70 mmol/L (30 mg/dL).Urine: No interference found up to 100 mg/dL (5.7 mmol/l).	No significant interference up to 1.70 mmol/L (30 mg/dL).
Interference - Creatine	No significant interference up to stated level.	No interference found up to 1.53 mmol/L (20 mg/dL).	No significant interference up to 1.53 mmol/L (20 mg/dL).

2. Sample Sizes used for the Test Set and the Data Provenance

Precision Studies: The document provides various "levels" (concentrations) for serum/plasma and urine. Each level typically has multiple measurements to calculate SD and CV. The exact number of individual samples/patients for precision studies is not explicitly stated, but it's common practice to use control materials or pooled patient samples across multiple runs.
Method Comparison Studies:
- Serum: N = 41 samples
- Plasma: N = 52 samples
- Urine: N = 135 samples
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's a submission by "Thermo Fisher Scientific Oy" from "Vantaa, Finland," it's highly probable the studies were conducted in Finland or at least led by the Finnish branch. Standard analytical validation studies are typically prospective tests on collected samples.

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

This is an analytical device for measuring creatinine concentration, not an imaging or diagnostic AI device that requires expert interpretation. The "ground truth" for the test set is established by:

Reference Methods: The predicate device (Roche/Hitachi 917 analyzer) is used as the comparative "reference" in the method comparison studies.
Traceability/Standardization: The device's calibration is traceable to NIST SRM 967 (for serum) and NIST SRM 914a (for urine), which are primary reference materials.
Known Concentrations: For precision studies, control materials or spiked samples with known creatinine concentrations are used.

Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation is not relevant here. The ground truth is analytical and based on established reference methods and standards.

4. Adjudication method for the test set

Not applicable for an analytical assay. Adjudication is typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies.

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

Not applicable. This is an in-vitro diagnostic (IVD) assay, not an AI or imaging device with human reader interaction.

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

Yes, the performance data presented (precision, method comparison, measuring range, limitations) represents the standalone performance of the CREATININE (Enzymatic) assay system (reagent + T60 instrument). There is no "human-in-the-loop" performance component beyond sample handling and instrument operation, which is standard for IVD assays.

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

The ground truth for this device is based on:

Reference Measurement Procedures: Comparison against a legally marketed predicate device (Roche/Hitachi 917 analyzer) which itself has established accuracy.
Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM 967 for serum, SRM 914a for urine), which provide certified concentrations.
Known Spiked Concentrations: For certain studies like interference testing, known concentrations of interfering substances are added.

Essentially, the ground truth is analytical accuracy and precision relative to established standards and methods.

8. The sample size for the training set

Not applicable in the context of this traditional IVD assay. There is no "training set" for an algorithm. The assay is a chemical reaction measured by an instrument.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" (analytical accuracy) for the device's development would have been established through rigorous chemical and analytical procedures, calibration with reference materials, and verification against known samples during product development.

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: 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 2P.O. Box 100FIN-01621 VantaaFinland
	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

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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

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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

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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

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Expected Values
	Serum/plasmaMale: 0.67 – 1.17 mg/dLFemale: 0.51 – 0.95 mg/dLUrineMale: 40 – 278 mg/dLFemale: 29 – 226 mg/dL	Serum, plasma:AdultsFemales: 0.51 – 0.95 mg/dLMales: 0.67 – 1.17 mg/dLChildrenNeonates (premature): 0.33 – 0.98 mg/dLNeonates (full term): 0.31 – 0.88 mg/dL2 - 12 m: 0.16 – 0.39 mg/dL1 -<3 y: 0.18 – 0.35 mg/dL3 -<5 y: 0.26 – 0.42 mg/dL5 -<7 y: 0.29 – 0.47 mg/dL7 -<9 y: 0.34 – 0.53 mg/dL9 -<11 y: 0.33 – 0.64 mg/dL11-<13y: 0.44 – 0.68 mg/dL13-<15y: 0.46 – 0.77 mg/dLUrine:First morning urine:Females: 29 – 226 mg/dLMales: 40 – 278 mg/dL24-hour urine:Females: 720 – 1510 mg/24hMales: 980 – 2200 mg/24hCreatinine clearance: 66 - 143 mL/min
Instrument	T60 and DPC T60i, DPC T60i Kusti	Cobas Integra 700
Measuring Range	Serum, plasma: 0.11 – 28 mg/dLUrine: 2.3 – 452 mg/dL	Serum, plasma: 0 – 30.5 mg/dLUrine: 0 – 452 mg/dL

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

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S C I E N T I F I C

Serum/plasma:		Serum/plasma:
Within run		Within run
Level 0.43 mg/dLSD= 0.006CV(%)= 1.5Level 1.75 mg/dLSD=0.008CV(%)=0.4Level 5.47 mg/dLSD= 0.021CV(%)=0.4		Level 1.0 mg/dLCV(%)= 1.6Level 3.7 mg/dLCV(%)= 0.7
Between run		Between run
Level 0.43 mg/dLSD= 0.002CV(%)=0.4Level 1.75 mg/dLSD=0.008CV(%)=0.5Level 5.47 mg/dLSD= 0.015CV(%)=0.3		Level 1.0 mg/dLCV(%)= 1.3Level 3.8 mg/dLCV(%)=0.9
Total		Urine:
Level 0.43 mg/dLSD= 0.009CV(%)=2.2Level 1.75 mg/dLSD= 0.026CV(%)= 1.5Level 5.47 mg/dLSD= 0.076CV(%)= 1.4		Within run
Urine:		Level 106 mg/dLCV(%)=0.8Level 231 mg/dLCV(%)= 1.8
Within run		Between run
Level 76 mg/dLSD= 0.7CV(%)= 1.0Level 90 mg/dLSD= 0.8CV(%)=0.8Level 165 mg/dLSD= 1.4CV(%)=0.9Level 251 mg/dLSD= 2.2CV(%)=0.9		Level 108 mg/dLCV(%)= 2.0Level 238 mg/dLCV(%)= 3.9
Between run
Thermo Fisher Scientific Oy	Level 76 mg/dLSD= 0.6CV(%)=0.8Level 90 mg/dLSD= 0.4CV(%)=0.5Level 165 mg/dLSD= 1.9CV(%)= 1.2Level 251 mg/dLSD= 2.3CV(%)=0.9	Ratastie 2P.O. Box 100FIN-01621 VantaaFinland	+358 (9) 329 100 tel+358 (9) 3291 0500 fax	Y-tunnus 0921547-0VAT No FI09215470Domicile Helsinki	www.thermo.com

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Image /page/6/Picture/8 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are stacked on top of the word "SCIENTIFIC". The text is in a bold, sans-serif font.

Total
Level 76 mg/dLSD= 2.7CV(%)= 3.5Level 90 mg/dLSD= 2.8CV(%)= 3.1Level 165 mg/dLSD= 5.7CV(%)= 3.5Level 251 mg/dLSD= 8.7CV(%)= 3.5
Method Comparison	Roche/Hitachi 917 analyzer
Serum:$y = 1.01x - 0.001$R = 1.000Range 0.12 to 24 mg/dLN = 41	Serum:$y = 1.01x + 1.13 µmol/l$r = 0.999n = 53range: 0.60 to 26.1 mg/dL
Plasma :Deming:$y = 0.97 - 0.02$r = 1.000Range 0.27 to 27.58 mg/dLN = 52	Urine:$y=0.94x + 0.63 mmol/l$r = 0.998n = 54range: 14.7 to 406 mg/dL
Urine :$y = 1.03x + 1.34$R = 0.999Range 2.33 to 422 mg/dLN = 135

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 IIelsinki

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・・・

Limitations	Serum/plasma:	Serum/plasma:
	Lipemia:No interference found up to 1000mg/dL (10 g/l) of Intralipid.Hemolysate:No interference found up to 1000mg/dL (10 g/l) of hemoglobin.Bilirubin, conjugated:No interference found up to 17mg/dL (300 $\mu$ mol/l) ofconjugated bilirubin.Bilirubin, unconjugated:No interference found up to 23mg/dL (400 $\mu$ mol/l) ofunconjugated bilirubin.Ascorbic acid:No interference found up to 1.70mmol/L (30 mg/dL) of ascorbicacidCreatine:No interference found up to 1.53mmol/L (20 mg/dL) of creatineDrugs:Levodopa and calcium dobesilatecause artificially low creatininelevels.	Lipemia:No significant interference upto a triglycerides level of 1000mg/dL and Intralipid level of1000 mg/dL.Hemolysate:No significant interference upto a hemoglobin level of 0.50mmol/L (8 g/l) of hemoglobin.Bilirubin:No significant interference upto a bilirubin level of 340$\mu$ mol/l (20 mg/dL)Ascorbic acid:No significant interference upto an ascorbic acid level of1.70 mmol/L (30 mg/dL)Drugs:Levodopa and calciumdobesilate cause artificiallylow creatinine levels at thetested drug level. DL-prolineat a concentration of >1mmol/L causes falsely highresults.Other:No significant interference upto a creatine level of 1.53mmol/L (20 mg/dL)
	Urine:Hemolysate:No interference found up to 1000mg/dL (10 g/l) of hemoglobin.Bilirubin, conjugated:No interference found up to 58mg/dL (1000 $\mu$ mol/l) ofconjugated bilirubin.Glucose:No interference found up to 2500mg/dL (139 mmol/l).Ascorbic acid:No interference found up to 100mg/dL (5.7 mmol/l).Drugs:Levodopa causes artificially lowresults.	Urine:Drugs:Levodopa causes artificiallylow resultsOther:No significant interference upto a creatine level of 3.05mmol/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

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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).

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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

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Indication for Use

510(k) Number (if known): K070824

Device Name: CREATININE (Enzymatic) sCal Nortrol Abtrol

Indication For Use:

Creatinine (Enzymatic)

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

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.