The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. 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 Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. 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 Instruments using methods defined by Thermo Fisher Scientific Oy.

Device Description

The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma.

sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet.

Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet.

AI/ML Overview

The provided text describes the 510(k) summary for the Thermo Fisher Scientific Oy Urea/BUN, sCal, Nortrol, and Abtrol devices. The information provided focuses on demonstrating substantial equivalence to a predicate device (Bayer ADVIA 2400 Chemistry System) for laboratory diagnostic tests.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table (Table 1) between the new device and the predicate device for several attributes. However, it does not explicitly state pre-defined acceptance criteria (e.g., "The new device's precision must be within X% of the predicate device"). Instead, it presents the performance data for both devices, implying that the new device's performance is deemed acceptable if it is comparable to the predicate device.

Table 1: Comparison of New Device (Urea / BUN) and Predicate Device (Bayer ADVIA Urea Nitrogen (UN) assay)

Attribute	New device #1 Reported Performance (Urea Nitrogen mg/dL)	Predicate device #1 Reported Performance (Urea Nitrogen mg/dL)
Intended Use	For in vitro diagnostic use in the quantitative determination of Urea / BUN (urea nitrogen) concentration in human serum or plasma on T60 instrument.	For in vitro diagnostic use in the quantitative determination of urea nitrogen in human serum, plasma (lithium heparin), and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of kidney disease, urinary tract obstruction, and acute or chronic renal failure.
Indication for Use	Intended for quantitative in vitro diagnostic measurement of urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.	See intended use.
Assay Protocol	Urea is hydrolysed to produce ammonia and carbon dioxide. Ammonia combines with α-ketoglutarate (α-KG) and NADH in the presence of GLDH to produce L-glutamate. Decrease in absorbance at 340 nm is proportional to urea level.	Urea is hydrolyzed to produce ammonia and carbon dioxide. Ammonia reacts with 2-oxoglutarate in the presence of glutamate dehydrogenase and NADH. Oxidation of NADH to NAD is measured as an inverse rate reaction at 340/410 nm.
Traceability/Standardization	Value assigned using NIST SRM 909b as a primary reference.	Traceable to the CDC reference method, which uses reference materials from NIST via patient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin) and urine
Reagent Storage	Unopened vials stable at 2...8 °C until expiration date.	Unopened reagents stable until expiration date when stored at 2°-8°C. Do not freeze reagents.
Expected Values	Serum, adult: Urea Nitrogen: 6 - 20 mg/dl (2.2 - 7.2 mmol/l); Urea: 13 - 43 mg/dl (2.2 - 7.2 mmol/l)	Serum: 9 - 23 mg/dL (3.2 – 8.2 mmol/L); Urine: 12 – 20 g/day (0.43 – 0.71 mol/day)
Instrument	T60 and DPC T60i, DPC T60i Kusti	ADVIA® 2400 Chemistry system.
Measuring Range	Serum: Urea nitrogen: 4.2 - 56 mg/dl (1.5 - 20.0 mmol/l); Urea: 9 - 120 mg/dl (1.5 - 20.0 mmol/l)	Serum: 5 - 150 mg/dL (1.8 – 53.6 mmol/L); Urine: 35 - 1000 mg/dL (12.5 - 357 mmol/L)
Precision	Within run: Level 5.7 mg/dL: SD=0.2, CV(%)= 3.1 Level 14.7 mg/dL: SD=0.2, CV(%)= 1.4 Level 24.7 mg/dL: SD=0.4, CV(%)= 1.7 Level 44.8 mg/dL: SD=0.4, CV(%)= 0.8 Between run: Level 5.7 mg/dL: SD=0.4, CV(%)= 7.4 Level 14.7 mg/dL: SD=0.1, CV(%)= 1.0 Level 24.7 mg/dL: SD=0.4, CV(%)= 1.8 Level 44.8 mg/dL: SD=0.4, CV(%)= 1.0 Total: Level 5.7 mg/dL: SD=0.5, CV(%)= 8.1 Level 14.7 mg/dL: SD=0.4, CV(%)= 2.7 Level 24.7 mg/dL: SD=0.9, CV(%)= 3.6 Level 44.8 mg/dL: SD= 1.0, CV(%)= 2.2	Serum: Within run: Level 19 mg/dL: SD=0.3, CV(%)= 1.4 Level 67 mg/dL: SD=0.3, CV(%)= 0.5 Level 81 mg/dL: SD=0.5, CV(%)=0.7 Total: Level 19 mg/dL: SD=0.4, CV(%)= 2.2 Level 67 mg/dL: SD= 1.0, CV(%)= 1.5 Level 81 mg/dL: SD= 1.3, CV(%)= 1.6 Urine: Within run: Level 453 mg/dL: SD=10.1, CV(%)= 2.2 Level 712 mg/dL: SD=28.6, CV(%)= 4.0 Total: Level 453 mg/dL: SD= 15.2, CV(%)= 3.4 Level 712 mg/dL: SD= 30.6, CV(%)= 4.3
Method Comparison	Comparison to Bayer ADVIA 2400: y = 0.94x + 0.25 R = 0.996 range from 4.3 to 117.3 mg/dL N = 143	Serum: ADVIA 1650: y = 1.01x + 0.0, r = 1.000, N = 229, Range 5.1 -146.8 mg/dL Reference Method: y = 1.04x - 0.1, r = 0.997, N = 50, Range 5.5-136.2 mg/dL Urine: ADVIA 1650: y = 0.95x + 2.3, 0.995, N = 51, Range 76.0 - 982.0 mg/dL
Limitations	Lipemia: No interference up to 1000 mg/dL (10 g/l) Intralipid. Hemolysate: No interference up to 1000 mg/dl (10 g/l) hemoglobin. Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l).	Lipemia (from Intralipid): No significant interference up to 625 mg/dl of Intralipid. Hemolysate: No significant interference up to 525 mg/dl of hemoglobin. Bilirubin: No significant interference up to 30 mg/dl.

Study Details to Prove Acceptance: Method Comparison Study

The primary study mentioned to demonstrate substantial equivalence and meet implied acceptance criteria is a method comparison study against the predicate device.

Acceptance Criteria (Implied): The new device's results should correlate strongly with the predicate device, demonstrated by a regression equation (y = mx + b) where 'm' is close to 1, 'b' is close to 0, and the correlation coefficient 'R' (or 'r') is close to 1. Limitations should also be comparable or better.
Study Description (New Device):
- Method Comparison: Comparison to Bayer ADVIA 2400.
- Regression Equation: y = 0.94x + 0.25 (where y is the new device and x is the predicate device).
- Correlation Coefficient: R = 0.996.
- Range: From 4.3 to 117.3 mg/dL.
- Sample Size: N = 143.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Types of Ground Truth: Not applicable in the traditional sense of expert consensus for imaging, as this is a quantitative chemical assay. The "ground truth" for the comparison is the measurement result from the predicate device (Bayer ADVIA 2400), which itself is established using a CDC reference method traceable to NIST materials.
- Training Set Sample Size & Ground Truth: Not applicable to this type of method comparison study for quantitative diagnostic devices. These devices are typically analytical rather than AI/machine learning driven, so "training sets" in that context are not relevant here.

Regarding other specific questions, based on the provided text:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: N = 143 for the method comparison study.
- Data Provenance: Not explicitly provided (e.g., country of origin, retrospective or prospective nature of the samples).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For quantitative diagnostic assays like Urea/BUN, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by human expert consensus as might be the case for image-based diagnostics. The predicate device's results serve as the comparison point, traceable to NIST standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of quantitative diagnostic device. Adjudication methods are typically relevant for subjective assessments, like interpreting medical images.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This is a comparison between two quantitative diagnostic devices (the new device and a predicate device). MRMC studies are specific to evaluating human reader performance, often with and without AI assistance, typically in image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself (Urea/BUN assay on the T60 instrument) operates in a standalone manner to produce a quantitative result. The method comparison study evaluates this standalone analytical performance against a comparator device. There is no "human-in-the-loop" aspect described for the assay's primary function.
The type of ground truth used: The ground truth for the comparison is the measurement obtained from the predicate device (Bayer ADVIA 2400), which itself is stated to be traceable to the CDC reference method and uses NIST reference materials. This indicates a high-level analytical standard as the basis for comparison.
The sample size for the training set: Not applicable for this type of device and study. These are chemical assays, not AI algorithms requiring a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of an AI algorithm described here.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in bold, and the word "SCIENTIFIC" is in a smaller font size below the first two words. The logo is in black and white.

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: K073295

Introduction: A.

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 Industrial Solutions and QRC
	Date of Preparation:	November 19th, 2007
C.	Device name
	Proprietary name:	Urea / BUN, codes 981818 and 981820
	Common name:	Urea nitrogen
	Classification:	Clinical Chemistry
	Class:	II
	Product Code:	CDQ
	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 Scientlfic Oy

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

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

www.thermo.com

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Urea / BUN

For in vitro diagnostic use in the quantitative determination of Urea / BUN (urea nitrogen) concentration in human serum or plasma on T60 instrument.

sCal, code 981831

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol

Abtrol

Ratastic 2 P.O. Box 100 FIN-01621 Vantas Finland

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No F109215470 Domicile Helsinki

www.thermo.com

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E. Indications for use

For sCal Calibrator, Nortrol and Abtrol see intended use.

F. Substantial Equivalence

Bayer Corporation, model Bayer ADVIA 2400 Chemistry System.

Bayer Corporation item: Bayer ADVIA Urea nitrogen (UN) assay.

G. Substantial equivalence -similarities

Urea / BUN is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Urea Nitrogen (UN) assay (K991576).

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

www.therno.com

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The following table compares the Urea / BUN with the predicate device Table 1 (Results as urea nitrogen mg/dL).

Attribute	New device #1	Predicate device #1
Intended Use	For in vitro diagnostic use in thequantitative determination of Urea/ BUN (urea nitrogen)concentration in human serum orplasma on T60 instrument.	For in vitro diagnostic use inthe quantitative determinationof urea nitrogen (an endproduct of nitrogenmetabolism) in human serum,plasma (lithium heparin), andurine on the ADVIAChemistry systems. Suchmeasurements are used in thediagnosis andtreatment of kidney disease,urinary tract obstruction, andacute or chronic renalfailure.
Indication for Use	The Urea / BUN test system isintended for quantitative in vitrodiagnostic measurement of urea /BUN (urea nitrogen)concentration in human serum orplasma. Such measurements areused in the diagnosis andtreatment of certain renal andmetabolic diseases.	See intended use.
Assay Protocol	Urea is hydrolysed in the presenceof water and urease to produceammonia and carbon dioxide. Inthe presence of glutamatedehydrogenase (GLDH) andreduced nicotinamide adeninedinucleotide (NADH), theammonia combines with a-ketoglutarate ( $α$ -KG) to produceL-glutamate.The resulting decrease inabsorbance at 340 nm, as NADHis converted to NAD, isproportional to the level of urea inthe sample.	Urea is hydrolyzed in thepresence of water and ureaseto produce ammonia andcarbon dioxide. The ammoniareacts with 2-oxoglutarate inthe presence of glutamatedehydrogenase and NADH.The oxidation of NADH toNAD is measured as aninverse rate reaction at340/410 nm.
Traceability/Standardization	The value of Urea / BUN hasbeen assigned by using NISTSRM 909b as a primary reference	The ADVIA UN method istraceable to the CDCreference method, which usesreference materials from theNational Institute of Standardsand Technology (NIST). viapatient sample correlation,
Attribute	New device #1	Predicate device #1
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin) and urine
Reagent Storage	Reagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label.	For all systems, unopened reagents are stable until the expiration date printed on the product label when stored at 2°-8°C. Do not freeze reagents.
Expected Values	Serum, adult:Urea Nitrogen: 6 - 20 mg/dl(2.2 - 7.2 mmol/l)Urea: 13 - 43 mg/dl(2.2 - 7.2 mmol/l)	Serum: 9 - 23 mg/dL(3.2 – 8.2 mmol/L)Urine 12 – 20 g/day(0.43 – 0.71 mol/day)
Instrument	T60 and DPC T60i, DPC T60i Kusti	ADVIA® 2400 Chemistry system.
Measuring Range	Serum:Urea nitrogen:4.2 - 56 mg/dl(1.5 - 20.0 mmol/l)Urea:9 - 120 mg/dl(1.5 - 20.0 mmol/l)	Serum:5 - 150 mg/dL(1.8 – 53.6 mmol/L)Urine:35 - 1000 mg/dL(12.5 - 357 mmol/L)
Attribute	New device #1	Predicate device #1
Precision	Within runLevel 5.7 mg/dLSD=0.2CV(%)= 3.1Level 14.7 mg/dLSD=0.2CV(%)= 1.4Level 24.7 mg/dLSD=0.4CV(%)= 1.7Level 44.8 mg/dLSD=0.4CV(%)= 0.8	Serum:Within runLevel 19 mg/dLSD=0.3CV(%)= 1.4Level 67 mg/dLSD=0.3CV(%)= 0.5Level 81 mg/dLSD=0.5CV(%)=0.7
	Between runLevel 5.7 mg/dLSD=0.4CV(%)= 7.4Level 14.7 mg/dLSD=0.1CV(%)= 1.0Level 24.7 mg/dLSD=0.4CV(%)= 1.8Level 44.8 mg/dLSD=0.4CV(%)= 1.0	TotalLevel 19 mg/dLSD=0.4CV(%)= 2.2Level 67 mg/dLSD= 1.0CV(%)= 1.5Level81 mg/dLSD= 1.3CV(%)= 1.6
	TotalLevel 5.7 mg/dLSD=0.5CV(%)= 8.1Level 14.7 mg/dLSD=0.4CV(%)= 2.7Level 24.7 mg/dLSD=0.9CV(%)= 3.6Level 44.8 mg/dLSD= 1.0CV(%)= 2.2	Urine:Within runLevel 453 mg/dLSD=10.1CV(%)= 2.2Level 712 mg/dLSD=28.6CV(%)= 4.0
		TotalLevel 453 mg/dLSD= 15.2CV(%)= 3.4Level 712 mg/dLSD= 30.6CV(%)= 4.3
Attribute	New device #1	Predicate device #1
Method Comparison	Comparison to Bayer ADVIA2400$y = 0.94x + 0.25$R = 0.996range from 4.3 to 117.3 mg/dLN = 143	Serum:ADVIA 1650$y = 1.01x + 0.0$r = 1.000N = 229Range 5.1 -146.8 mg/dLReference Method$y = 1.04x - 0.1$r = 0.997N = 50Range 5.5-136.2 mg/dLUrine:ADVIA 1650$y = 0.95x + 2.3$0.995N = 51Range 76.0 - 982.0 mg/dL
Limitations	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 hemoglobinBilirubin, conjugated:No interference found up to 58mg/dL (1000 µmol/l) ofconjugated bilirubin.Bilirubin, unconjugated:No interference found up to 58mg/dL (1000 µmol/l) ofunconjugated bilirubin.	Lipemia (from Intralipid):No significant interferencefound up to 625 mg/dl ofIntralipid.Hemolysate:No significant interferencefound up to 525 mg/dl ofhemoglobin.Bilirubin:No significant interferencefound up to 30 mg/dl.

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ﺒﺤﺮ

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

www.thermo.comn

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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

www.thermo.com

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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 Fl09215470
Domicile Helsinki

ww.thermo.com

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Image /page/7/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific Oy c/o Mr. Päivi Sormunen Vice President of Industrial Solutions and QRC Ratastie 2, P.O. Box 100 01621 Vantaa, Finland

Re: K073295 Trade Name: Urea/Bun, sCal, Nortrol, Abtrol Regulation Number: 21 CFR 862.1770 Regulation Name: Urea Nitrogen Test System Regulatory Class: Class II Product Codes: CDQ, JIX, JJY Dated: March 20, 2008 Received: March 28, 2008

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.

MAY 2 9 2008

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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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.

Yean 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):

K073295

Device Name:

Urea / BUN, sCal, Nortrol, Abtrol

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy

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

Over the Counter Use (21 CFR Part 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 (OVD)

Carol Benson

Division Sign Of Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073295

Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.