The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

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

Not Found

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Uric Acid (AOX) device based on the provided 510(k) summary:

This device is an IVD (In Vitro Diagnostic) and the criteria and performance metrics are related to analytical performance, not clinical performance metrics typical of AI/ML devices for diagnostic imaging studies. Therefore, many of the requested fields for AI/ML studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device K991576)	Reported Device Performance (Uric Acid (AOX))
Measuring Range	Serum: 0 - 20 mg/dL	Serum: 0.2 - 20.0 mg/dl (10 - 1200 µmol/l)
	Urine: 0 - 180 mg/dL	Not applicable (device does not test urine)
Precision	Within Run:	Within Run:
	Level 3.9 mg/dL: CV(%) = 1.1	Level 1.2 mg/dL: CV(%) = 0.8
	Level 8.6 mg/dL: CV(%) = 1.1	Level 2.3 mg/dL: CV(%) = 0.7
	Level 10.0 mg/dL: CV(%) = 0.6	Level 4.4 mg/dL: CV(%) = 0.7
		Level 8.9 mg/dL: CV(%) = 0.5
	Total Precision:	Between Run:
	Level 3.9 mg/dL: CV(%) = 1.9	Level 1.2 mg/dL: CV(%) = 1.3
	Level 8.6 mg/dL: CV(%) = 1.6	Level 2.3 mg/dL: CV(%) = 0.9
	Level 10.0 mg/dL: CV(%) = 2.3	Level 4.4 mg/dL: CV(%) = 0.7
		Level 8.9 mg/dL: CV(%) = 0.4
		Total Precision:
		Level 1.2 mg/dL: CV(%) = 2.3
		Level 2.3 mg/dL: CV(%) = 1.7
		Level 4.4 mg/dL: CV(%) = 2.8
		Level 8.9 mg/dL: CV(%) = 1.1
Method Comparison	Comparison to Technicon DAX: r = 0.994	Comparison to Bayer ADVIA 2400: R = 0.999
	Range: 0.2 - 18.0 mg/dL	Range: 0.3 to 12.6 mg/dL
	N = 154	N = 105
	Comparison to Reference Method: r = 0.999
	Range: 1.7 - 19.5 mg/dL
	N = 49
Limitations	Hemolysate: No significant interference up	Lipemia: No interference up to 900 mg/dl
	to 525 mg/dl of hemoglobin	Hemolysate: No interference up to 1000 mg/dl of hemoglobin
	Bilirubin: No significant interference up	Bilirubin conjugated: No interference up
	to 30 mg/dl	to 11 mg/dl
	Triglycerides: Effect measured	Bilirubin total: No interference up to
		14 mg/dl

Note: The acceptance criteria for the new device are implicitly demonstrated by showing comparable or better performance relative to the predicate device across the various analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" but rather presents a comparison to the predicate, implying that performance similar to or better than the predicate is considered acceptable.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison (Linearity/Correlation): N = 105 human serum/plasma samples (range 0.3 to 12.6 mg/dL).
Precision: Not explicitly stated as "sample size" but rather "levels" tested (e.g., Level 1.2 mg/dL, 2.3 mg/dL, 4.4 mg/dL, 8.9 mg/dL) with corresponding SD and CV values. Typically, precision studies involve multiple replicates of control or patient samples.
Limitations (Interference): Specific concentrations of interfering substances (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested. The number of samples for each interference test is not explicitly stated.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human serum or plasma" samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for an in vitro diagnostic (IVD) device that quantifies a biomarker (uric acid) using chemical reactions on an instrument. The "ground truth" for the test set is established by comparative measurements against a legally marketed predicate device (Bayer ADVIA 2400) and/or reference methods, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic decisions (e.g., in medical imaging).

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No. This is an IVD device for quantitative measurement, not a diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, effectively. The performance data presented (measuring range, precision, method comparison, limitations) are measurements of the device's analytical performance on its own (algorithm/reagent/instrument combination) without human qualitative interpretation being a variable. The device provides a quantitative measurement, and its accuracy and precision are assessed directly.

7. The Type of Ground Truth Used

Comparative Measurement to a Predicate Device and Traceability to a Primary Reference (NIST SRM 909b).
- Method Comparison: The device's results were compared to the Bayer ADVIA 2400 Chemistry System, which serves as a widely accepted "ground truth" for method comparison in IVD submissions.
- Traceability/Standardization: The value of Uric Acid (AOX) is stated to be assigned using NIST SRM 909b as a primary reference. The predicate device also establishes traceability to the CDC candidate reference method, which uses NIST reference materials. This indicates a strong chain of traceability to established analytical standards for ground truth.

8. The Sample Size for the Training Set

Not explicitly stated/applicable in the context of this traditional IVD. Traditional IVDs like this do not typically use "training sets" in the same way machine learning algorithms do. The development process involves optimizing the reagent formulation and instrument parameters, which is an iterative process, but not framed as "training" with a specific data set.

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated/applicable. As mentioned above, the concept of a "training set" and establishing ground truth for it is not directly transferable to the development of this type of IVD device. The development relies on principles of analytical chemistry, reagent formulation, and instrument engineering to achieve accurate and precise measurements traceable to established standards.

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: K07 36 12.

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.

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:	December 10th, 2007
C.	Device name
	Proprietary name:	Uric Acid (AOX), codes 981391 and 981788
	Common name:	Uric acid
	Classification:	Clinical Chemistry
	Class:	I
	Product Code:	KNK
	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

1358 (9) 329 100 tel +358 (9) 3291 0500 fax

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D. Intended Use

Uric Acid (AOX)

For in vitro diagnostic use in the quantitative determination of uric acid 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

For in vitro diagnostic use for quantitative testing on T6() 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.

Y-tunnus 0921 547-0 VAT No FI09215470 Domicile Helsmki

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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 Uric Acid (UA) assay.

G. Substantial equivalence -similarities

Uric Acid is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Uric Acid (UA) assay (K991576).

Y-tunnus 0921 547-0 VAT No F109215470 Domicile Helsinki

www.thermo.com

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The following table compares the Uric Acid with the predicate device

Attribute	New device #1	Predicate device #1
Intended Use	For in vitro diagnostic use in thequantitative determination of uricacid concentration in humanserum or plasma on T60instrument.	For in vitro diagnostic use inthe quantitative determinationof uric acid in human serum,plasma and urine on theADVIA® 1650 Chemistrysystem. Such measurementsare used in the diagnosis andtreatment of renal failure, goutand eclampsia
Indication for Use	The Uric Acid test system isintended for quantitative in vitrodiagnostic measurement of uricacid concentration in humanserum or plasma. Suchmeasurements are used in thediagnosis and treatment ofnumerous renal and metabolicdisorders, including renal failureand gout.	See intended use.
Assay Protocol	Uric acid is oxidized to allantoinby uricase. The generatedhydrogen peroxide reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(hydroxy-3-sulfopropyl)-m-toluidin (TOOS) to a blueviolet dye. The absorbance of theformed colour is measured at 540nm.	The uric acid is converted byuricase to allantoin andhydrogen peroxide. A coloredcomplex is formed fromhydrogen peroxide, 4-aminophenazone and TOOS[N-ethyl-N-(2-hydroxy-sulfopropyl)-3-methylaniline]under the catalytic influenceof peroxide. The absorbanceof the complex is measured asan endpoint reaction at 545nm.
Traceability/Standardization	The value of Uric Acid has beenassigned by using NIST SRM909b as a primary reference.	The ADVIA 1650 Uric Acidmethod is traceable to theCDC candidate referencemethod, which usesreference materials from theNational Institute of Standardsand Technology (NIST) viapatient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)and urine
Reagent Storage	Reagents in unopened vials arestable at 2... 8 °C until theexpiration date printed on thelabel, when protected from light.	Store at 2°-8°C. Unopenedreagents are stable until theexpiration date printed on theproduct label.
Expected Values		Serum:
	Serum, adult:Male: 3.5 - 7.2 mg/dl(210 - 420 µmol/l)Female: 2.6 - 6.0 mg/dl(150 - 350 µmol/l)	Male: 3.5 - 7.2 mg/dL(208 – 428 µmol/L)Female: 2.6 - 6.0 mg/dL(155 - 357 µmol/L)Urine 250 - 750 mg/day(1.48 – 4.43 mmol/day)
Instrument	T60 and DPC T60i, DPC T60iKusti	ADVIA® 2400 Chemistrysystem.
Measuring Range	Serum:0.2 - 20.0 mg/dl(10 - 1200 µmol/l)	Serum:0 - 20 mg/dLUrine:0 - 180 mg/dL
Precision	Within runLevel 1.2 mg/ dLSD=0.009CV(%)= 0.8Level 2.3 mg/ dLSD=0.017CV(%)= 0.7Level 4.4 mg/dLSD=0.030CV(%)= 0.7Level 8.9 mg/ dLSD=0.045CV(%)= 0.5Between runLevel 1.2 mg/ dLSD=0.015CV(%)= 1.3Level 2.3 mg/ dLSD= 0.020CV(%)= 0.9Level 4.4 mg/ dLSD= 0.030CV(%)= 0.7Level 8.9 mg/ dLSD= 0.039CV(%)= 0.4	Serum:Within runLevel 3.9 mg/dLSD=0.04CV(%)= 1.1Level 8.6 mg/dLSD=0.10CV(%)= 1.1Level 10.0 mg/dLSD=0.06CV(%)=0.6TotalLevel 3.9 mg/dLSD=0.07CV(%)= 1.9Level 8.6 mg/dLSD=0.14CV(%)= 1.6Level 10.0 mg/dLSD=0.23CV(%)= 2.3Urine:Within runLevel 12.4 mg/dLSD=0.14CV(%)= 1.1Level 23.9 mg/dLSD=0.16CV(%)= 0.7
	Total	Total
	Level 1.2 mg/dLSD= 0.026CV(%)= 2.3Level 2.3 mg/dLSD= 0.038CV(%)= 1.7Level 4.4 mg/dLSD= 0.123CV(%)= 2.8Level 8.9 mg/dLSD= 0.094CV(%)= 1.1	Level 12.4 mg/dLSD= 0.14CV(%)=1.1Level 23.9 mg/dLSD= 1.24CV(%)= 5.2
Method Comparison	Comparison to Bayer ADVIA 2400$y = 1.06x - 0.12$R = 0.999range from 0.3 to 12.6 mg/dLN = 105	Serum:Technicon DAX$y = 1.51x + 0.48$r = 0.994N = 154Range 0.2 - 18.0 mg/dLReference Method$y = 1.01x - 0.05$r = 0.999N = 49Range 1.7-19.5 mg/dLUrine:Beckman CX7$y = 1.03x - 0.5$r = 0.989N = 30Range 8 - 91 mg/dL
Limitations	Lipemia:No interference found up to 900 mg/dl (9 g/l) of Intralipid.Hemolysate:No interference found up to 1000 mg/dl (10 g/l) of hemoglobinBilirubin conjugated:No interference found up to 11 mg/dl (200 µmol/l) of conjugated bilirubinBilirubin total:No interference found up to 14 mg/dl (250 µmol/l) of unconjugated bilirubin.	Hemolysate:No significant interference found up to 525 mg/dl of hemoglobin.Bilirubin:No significant interference found up to 30 mg/dl.Triglycerides:The effect of triglycerides has been measured at analyte concentrations 3.4 mg/dL and 8.9 mg/dL. The observed interference is expressed as an interference index. Please refer to ADVIA 1650 Uric Acid (UA) package insert.

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

+358 (9) 329100 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921 547-0
VAT No FI0921 5470
Domicile IIelsinki

www.thermo.com

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I hermorisher S C I E N T I F I C

Thermo Fisher Scientific Oy

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

: 358 (9) 329 | 00 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921 S47-0
VAT No FI09215470
Domicile Helsinki

ど

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES / USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 2008

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

K073612 Re: Trade Name: sCal, Nortrol, Abtrol, Uric Acid (AOX) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX, JJY, KNK Dated: April 2, 2008 Received: April 4, 2008

Dear Ms. 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 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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Indication for Use

510(k) Number (if known): CO736 12

Device Name: Uric Acid (AOX), sCal, Nortrol, Abtrol

The Uric Acid test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

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 (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073412

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.