URIC ACID (AOX), SCAL, NORTROL, ABTROL

K073612 · Thermofisher Scientific OY · JIX · May 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073612
• Device Name: URIC ACID (AOX), SCAL, NORTROL, ABTROL
• Applicant: Thermofisher Scientific OY
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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 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. 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.

Device Story

Uric Acid (AOX) system performs quantitative in vitro diagnostic measurement of uric acid in human serum or plasma; utilizes T60 clinical chemistry instrument. Principle: uric acid oxidized to allantoin by uricase; generated hydrogen peroxide reacts with 4-aminoantipyrine and TOOS to form blue-violet dye; absorbance measured at 540 nm. System includes sCal (multicalibrator) and Nortrol/Abtrol (control sera) to monitor assay trueness and precision. Used in clinical laboratory settings by trained personnel. Output provides uric acid concentration values to assist physicians in diagnosing/treating renal failure and gout.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing: precision (CLSI EP5-A), linearity (CLSI EP6-A), limit of detection (CLSI EP17-A), and interference testing (CLSI EP7-A). Method comparison (CLSI EP9-A) using 136 Li-heparin plasma samples showed Deming regression y = 1.07x - 0.13, R=0.999 against predicate. Matrix comparison (serum vs. plasma) showed R=1.000.

Technological Characteristics

Enzymatic, colorimetric assay. Reagents: Phosphate buffer, TOOS, 4-aminoantipyrine, ascorbate oxidase, uricase, peroxidase, K4[Fe(CN)6], sodium azide. Form factor: Liquid reagent kit for T60/T60i analyzer. Measuring range: 0.2-20.0 mg/dL (extended to 40.0 mg/dL). Traceability: NIST SRM 909b. Stability: 32 days on-board.

Indications for Use

Indicated for quantitative in vitro diagnostic measurement of uric acid in human serum or plasma to aid in the diagnosis and treatment of renal and metabolic disorders, including renal failure and gout. For prescription use only on the T60/T60i Chemistry Analyzer.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Uric Acid (UA), Advia, Bayer Corp. (k991576)

Submission Summary (Full Text)

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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 2<br>P.O. Box 100<br>FIN-01621 Vantaa<br>Finland |
| | Phone: | [phone] tel |
| | Fax: | [phone] 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 [phone] 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

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.

## 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

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 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 <i>in vitro</i> diagnostic use in the<br>quantitative determination of uric<br>acid concentration in human<br>serum or plasma on T60<br>instrument. | For <i>in vitro</i> diagnostic use in<br>the quantitative determination<br>of uric acid in human serum,<br>plasma and urine on the<br>ADVIA® 1650 Chemistry<br>system. Such measurements<br>are used in the diagnosis and<br>treatment of renal failure, gout<br>and eclampsia |
| Indication for Use | The Uric Acid test system is<br>intended for quantitative <i>in vitro</i><br>diagnostic measurement of uric<br>acid concentration in human<br>serum or plasma. Such<br>measurements are used in the<br>diagnosis and treatment of<br>numerous renal and metabolic<br>disorders, including renal failure<br>and gout. | See intended use. |
| Assay Protocol | Uric acid is oxidized to allantoin<br>by uricase. The generated<br>hydrogen peroxide reacts with 4-<br>aminoantipyrine (4-AAP) and N-<br>ethyl-N-(hydroxy-3-sulfopropyl)-<br>m-toluidin (TOOS) to a blue<br>violet dye. The absorbance of the<br>formed colour is measured at 540<br>nm. | The uric acid is converted by<br>uricase to allantoin and<br>hydrogen peroxide. A colored<br>complex is formed from<br>hydrogen peroxide, 4-<br>aminophenazone and TOOS<br>[N-ethyl-N-(2-hydroxy-<br>sulfopropyl)-3-methylaniline]<br>under the catalytic influence<br>of peroxide. The absorbance<br>of the complex is measured as<br>an endpoint reaction at 545<br>nm. |
| Traceability/Standar<br>dization | The value of Uric Acid has been<br>assigned by using NIST SRM<br>909b as a primary reference. | The ADVIA 1650 Uric Acid<br>method is traceable to the<br>CDC candidate reference<br>method, which uses<br>reference materials from the<br>National Institute of Standards<br>and Technology (NIST) via<br>patient sample correlation. |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin)<br>and urine |
| Reagent Storage | Reagents in unopened vials are<br>stable at 2... 8 °C until the<br>expiration date printed on the<br>label, when protected from light. | Store at 2°-8°C. Unopened<br>reagents are stable until the<br>expiration date printed on the<br>product label. |
| Expected Values | | Serum: |
| | Serum, adult:<br>Male: 3.5 - 7.2 mg/dl<br>(210 - 420 µmol/l)<br>Female: 2.6 - 6.0 mg/dl<br>(150 - 350 µmol/l) | Male: 3.5 - 7.2 mg/dL<br>(208 – 428 µmol/L)<br>Female: 2.6 - 6.0 mg/dL<br>(155 - 357 µmol/L)<br>Urine 250 - 750 mg/day<br>(1.48 – 4.43 mmol/day) |
| Instrument | T60 and DPC T60i, DPC T60i<br>Kusti | ADVIA® 2400 Chemistry<br>system. |
| Measuring Range | Serum:<br>0.2 - 20.0 mg/dl<br>(10 - 1200 µmol/l) | Serum:<br>0 - 20 mg/dL<br><br>Urine:<br>0 - 180 mg/dL |
| Precision | Within run<br>Level 1.2 mg/ dL<br>SD=0.009<br>CV(%)= 0.8<br>Level 2.3 mg/ dL<br>SD=0.017<br>CV(%)= 0.7<br>Level 4.4 mg/dL<br>SD=0.030<br>CV(%)= 0.7<br>Level 8.9 mg/ dL<br>SD=0.045<br>CV(%)= 0.5<br><br>Between run<br>Level 1.2 mg/ dL<br>SD=0.015<br>CV(%)= 1.3<br>Level 2.3 mg/ dL<br>SD= 0.020<br>CV(%)= 0.9<br>Level 4.4 mg/ dL<br>SD= 0.030<br>CV(%)= 0.7<br>Level 8.9 mg/ dL<br>SD= 0.039<br>CV(%)= 0.4 | Serum:<br>Within run<br>Level 3.9 mg/dL<br>SD=0.04<br>CV(%)= 1.1<br>Level 8.6 mg/dL<br>SD=0.10<br>CV(%)= 1.1<br>Level 10.0 mg/dL<br>SD=0.06<br>CV(%)=0.6<br><br>Total<br>Level 3.9 mg/dL<br>SD=0.07<br>CV(%)= 1.9<br>Level 8.6 mg/dL<br>SD=0.14<br>CV(%)= 1.6<br>Level 10.0 mg/dL<br>SD=0.23<br>CV(%)= 2.3<br><br>Urine:<br>Within run<br>Level 12.4 mg/dL<br>SD=0.14<br>CV(%)= 1.1<br>Level 23.9 mg/dL<br>SD=0.16<br>CV(%)= 0.7 |
| | Total | Total |
| | Level 1.2 mg/dL<br>SD= 0.026<br>CV(%)= 2.3<br>Level 2.3 mg/dL<br>SD= 0.038<br>CV(%)= 1.7<br>Level 4.4 mg/dL<br>SD= 0.123<br>CV(%)= 2.8<br>Level 8.9 mg/dL<br>SD= 0.094<br>CV(%)= 1.1 | Level 12.4 mg/dL<br>SD= 0.14<br>CV(%)=1.1<br>Level 23.9 mg/dL<br>SD= 1.24<br>CV(%)= 5.2 |
| Method Comparison | Comparison to Bayer ADVIA 2400<br>$y = 1.06x - 0.12$<br>R = 0.999<br>range from 0.3 to 12.6 mg/dL<br>N = 105 | Serum:<br>Technicon DAX<br>$y = 1.51x + 0.48$<br>r = 0.994<br>N = 154<br>Range 0.2 - 18.0 mg/dL<br><br>Reference Method<br>$y = 1.01x - 0.05$<br>r = 0.999<br>N = 49<br>Range 1.7-19.5 mg/dL<br><br>Urine:<br>Beckman CX7<br>$y = 1.03x - 0.5$<br>r = 0.989<br>N = 30<br>Range 8 - 91 mg/dL |
| Limitations | Lipemia:<br>No interference found up to 900 mg/dl (9 g/l) of Intralipid.<br><br>Hemolysate:<br>No interference found up to 1000 mg/dl (10 g/l) of hemoglobin<br><br>Bilirubin conjugated:<br>No interference found up to 11 mg/dl (200 µmol/l) of conjugated bilirubin<br><br>Bilirubin total:<br>No interference found up to 14 mg/dl (250 µmol/l) of unconjugated bilirubin. | Hemolysate:<br>No significant interference found up to 525 mg/dl of hemoglobin.<br><br>Bilirubin:<br>No significant interference found up to 30 mg/dl.<br><br>Triglycerides:<br>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

[phone] tel
[phone] 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
[phone] fax

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

ど

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·

[phone] tel
[phone] 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 [phone]. 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 [phone] or [phone] 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

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.

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