AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

K071580 · Thermofisher Scientific OY · CIT · Oct 3, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071580
• Device Name: AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
• Applicant: Thermofisher Scientific OY
• Product Code: CIT · Clinical Chemistry
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

The AST/GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. Auxiliary product: Pyridoxal Phosphate Auxiliary reagent for in vitro diagnostic use in the quantitative determination of AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument. eCal For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests 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 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 T60 instrument. Abtrol is a control serum to monitor 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

The AST/GOT (IFCC) test system is an in vitro diagnostic assay for measuring aspartate aminotransferase activity in human serum or plasma. The device utilizes either a 1-reagent modified IFCC method or a 3-reagent IFCC reference method (with Pyridoxal Phosphate). The assay is performed on the T60 clinical chemistry instrument. The system includes auxiliary reagents (Pyridoxal Phosphate), a multi-analyte calibrator (eCal), and control sera (Nortrol, Abtrol) to ensure analytical precision. The instrument processes the sample and reagent mixture, measuring enzyme activity via spectrophotometric analysis. Healthcare providers use the resulting quantitative values to aid in the diagnosis and monitoring of liver and heart disease. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical trials performed. Bench testing only. Precision evaluated per CLSI EP5-A (20-day study, 80 data points). Linearity validated per CLSI EP6-A. Interference testing per CLSI EP7-A. Method comparison against predicate (n=85) showed r=0.992 (1-reagent) and r=0.994 (3-reagent). Matrix comparison (serum vs. plasma) showed r=0.99 and r=0.98 respectively.

Technological Characteristics

In vitro diagnostic reagent system for clinical chemistry. Utilizes 1-reagent (modified IFCC) or 3-reagent (IFCC reference) enzymatic methods. Measures enzyme activity via spectrophotometry. Designed for use on T60/T60i clinical chemistry instruments. Reagents stored at 2-8°C. Traceable to NADH molar absorbance or IFCC reference method.

Indications for Use

Indicated for quantitative in-vitro diagnostic determination of aspartate amino transferase (AST/SGOT) activity in human serum and plasma on T60 instruments. Aids in diagnosis and treatment of liver and heart disease.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

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

• Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)

Submission Summary (Full Text)

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OCT 3" 2007

## 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: K071580

### 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<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: | June 6th, 2007 |
| C. | Device name | |
| | Proprietary name: | AST / GOT (IFCC), codes 981363 and 981771 |
| | Common name: | AST / GOT (IFCC) |
| | Classification: | Clinical Chemistry |
| | Class: | II |
| | Product Code: | CIT |
| | Auxiliary product | |
| | Proprietary name: | Pyridoxal Phosphate, code 981839 |
| | Common name: | Pyridoxal Phosphate |
| | Proprietary name: | eCal, code 981830 |
| | 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 |

Thermo Fisher Scientific Oy

Class:

Product Code:

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

I

JJY

[phone] tel
[phone] fax

Y-lunnus 0921547-0
VAT No FI09215470 Domicile Helsinki

ww.thermo.com

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| Proprietary name: | Abtrol, code 981044 |
|-------------------|------------------------------------------------|
| Common Name: | Multi-analyte Controls (Assayed and unassayed) |
| Classification: | Clinical Chemistry |
| Class: | I |
| Product Code: | JJY |

### Intended Use D.

## AST/ GOT (IFCC)

For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human serum or plasma on T60 instrument.

## Pvridoxal Phosphate

Auxiliary reagent for in vitro diagnostic use in the quantitative determination of AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

## eCal

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests 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 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 T60 instrument. Abtrol is a control serum to monitor 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.

Ratastic 2 P.O. Box 100 FIN-0162 | Vantaa Finland

[phone] tel [phone] fax

Y-tunnus ()921547-0 VAT No FI09215470 Domicile Helsinki

www.themmo con

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#### E. Indications for use

The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

Auxiliary product: Pyridoxal Phosphate

Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

For eCal Calibrator, Nortrol and Abtrol see intended use.

### Substantial Equivalence F.

Bayer Corporation, model Bayer ADVIA 1650 Chemistry System.

Bayer Corporation item: Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay.

### Substantial equivalence -similarities G.

AST/ GOT (IFCC) is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136).

Thermo Fisher Scientific Oy

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

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No F109215470 Domicile Helsinki

www.themo.con

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The following table compares the AST/ GOT (IFCC) with the predicate device. Table 1

| Table 1<br>Attribute | New device #1 | Predicate device #1 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the<br>quantitative determination of<br>aspartate aminotransferase (L-<br>Aspartate: 2-Oxoglutarate<br>Aminotransferase (AST), EC<br>2.6.1.1) activity in human serum<br>or plasma on T60 instrument. | For in vitro diagnostic use in<br>the quantitative determination<br>of aspartate<br>aminotransferase activity in<br>human serum and plasma on<br>the ADVIA Chemistry<br>systems. Such measurements<br>are used mainly to determine<br>the progress and<br>prognosis of patients with<br>myocardial infarction and the<br>diagnosis and monitoring of<br>liver disease. |
| Indication for Use | The AST/ GOT (IFCC) test<br>system is intended for<br>quantitative in-vitro diagnostic<br>determination of the activity of<br>the enzyme aspartate amino<br>transferase (AST) (also known as<br>a serum glutamic oxaloacetic<br>transferase or SGOT) in serum<br>and plasma on T60 instrument.<br>Measurement of aspartate amino<br>transferase levels aids in the<br>diagnosis and treatment of certain<br>types of liver and heart disease. | See intended use. |
| Assay Protocol | 1-reagent method: Modified<br>IFCC reference method (without<br>PyP )<br>3-reagent method: IFCC<br>reference method | 1-reagent method: Modified<br>IFCC<br>3-reagent method: IFCC |
| Traceability/Standar<br>dization | The AST/ GOT (IFCC) 1-reagent<br>method is traceable to the molar<br>absorbance coefficient of NADH.<br>The AST/ GOT (IFCC) 3-reagent<br>method is traceable to the IFCC<br>reference method. | The ADVIA AST and AST<br>P5P method standardization is<br>traceable to the IFCC reference<br>method via patient sample<br>correlation. |
| Sample Type | Serum, plasma (heparin) | Serum, plasma (Li-heparin) |
| Reagent Storage | Reagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label when protected from light. | Unopened reagents are stable until the expiration date printed on the product label when stored at 2 - 8°C. |
| Expected Values | Male: < 35 U/l<br>Female: < 31 U/l | 1-reagent method: < 34 U/l<br>3-reagent method: 13-40 U/l |
| Instrument | T60 and DPC T60i, DPC T60i Kusti | ADVIA® 1650 Chemistry system. |
| Measuring Range | 1-reagent method: 4 – 350 U/l<br>3-reagent method: 4 - 300 U/l | 0 - 1000 U/l |
| Precision | 1-reagent method:<br>Within run<br>Level 38 U/l<br>SD= 0.5<br>CV(%)= 1.4<br>Level 101 U/l<br>SD=0.9<br>CV(%)= 0.9<br>Level 189 U/l<br>SD= 1.0<br>CV(%)= 0.5<br>Between run<br>Level 38 U/l<br>SD= -<br>CV(%)= -<br>Level 101 U/l<br>SD=0.5<br>CV(%)= 0.5<br>Level 189 U/l<br>SD= 1.1<br>CV(%)= 0.6<br>Total<br>Level 38 U/l<br>SD= 0.9<br>CV(%)= 2.4<br>Level 101 U/l<br>SD= 2.0<br>CV(%)= 2.0<br>Level 189 U/l<br>SD= 3.2<br>CV(%)= 1.7 | 1-reagent method:<br>Within run<br>Level 42 U/l<br>SD= 0.8<br>CV(%)= 2.1<br>Level 188 U/l<br>SD=1.3<br>CV(%)=0.7<br>Total<br>Level 42 U/l<br>SD= 1.3<br>CV(%)= 3.3<br>Level 188 U/l<br>SD= 4.1<br>CV(%)= 2.3<br>3-reagent method:<br>Within run<br>Level 50 U/l<br>SD= 0.6<br>CV(%)= 1.5<br>Level 195 U/l<br>SD=1.3<br>CV(%)= 1.1<br>Total<br>Level 50 U/l<br>SD= 1.0<br>CV(%)= 2.7<br>Level 195 U/l<br>SD= 2.5<br>CV(%)= 2.0 |
| | 3-reagent method: | |
| | | |
| | Within run<br>Level 37 U/l | |
| | SD=0.6 | |
| | CV(%)= 1.5 | |
| | Level 124 U/l | |
| | SD=1.3 | |
| | CV(%)= 1.1 | |
| | Level 191 U/l | |
| | SD= 1.0 | |
| | CV(%)= 0.5 | |
| | Between run | |
| | Level 37 U/l | |
| | SD=0.4 | |
| | CV(%)= 1.0 | |
| | Level 124 U/l | |
| | SD=1.4 | |
| | CV(%)= 1.1 | |
| | Level 191 U/l | |
| | SD= 1.2 | |
| | CV(%)=0.6 | |
| | Total | |
| | Level 37 U/l | |
| | SD= 1.0 | |
| | CV(%)= 2.7 | |
| | Level 124 U/l | |
| | SD= 2.5 | |
| | CV(%)= 2.0 | |
| | Level 191 U/l | |
| | SD= 2.9 | |
| | CV(%)= 1.5 | |
| Method Comparison | 1-reagent method: | |
| | $y = 0.95x - 2.0$ | |
| | R = 0.992 | Comparison with Technicon |
| | Range 12 to 307 U/L<br>N = 83 | DAX: |
| | 3-reagent method: | $y = 0.99x - 6.3 U/l$ |
| | $y = 0.94x + 1.3$ | r = 0.999 |
| | R = 0.994 | n = 111 |
| | Range 15 to 408 U/L | range: 9.8 to 607.2 U/l |
| | N = 84 | |
| | | |
| | | |
| | | |
| Limitations | 1-reagent method: | |
| | Lipemia:<br>No interference found up to 150 mg/dL (1.5 g/l) of Intralipid. | 1-reagent method:<br>Lipemia (from Intralipid):<br>No significant interference found up to 488 mg/dl of Intralipid. |
| | Hemolysate:<br>Avoid hemolyzed samples. | Hemolysate: Avoid hemolyzed samples |
| | Bilirubin, conjugated:<br>No interference found up to 35 mg/dL (600 µmol/l) of conjugated bilirubin. | Bilirubin (conjugated and unconjugated): No significant interference found up to 30 mg/dl (513 µmol/l) |
| | Bilirubin, unconjugated:<br>No interference found up to 35 mg/dL (600 µmol/l) of unconjugated bilirubin. | |
| | 3-reagent method: | |
| | Lipemia:<br>No interference found up to 150 mg/dL (1.5 g/l) of Intralipid. | 3-reagent method:<br>(AST Sample Concentration 65 U/l) |
| | Hemolysate:<br>Avoid hemolyzed samples. | Lipemia (from Intralipid):<br>No significant interference found up to 488 mg/dl. |
| | Bilirubin, conjugated:<br>No interference found up to 58 mg/dL (1000 µmol/l) of conjugated bilirubin. | Hemolysate: Avoid hemolyzed samples |
| | Bilirubin, unconjugated:<br>No interference found up to 58 mg/dL (1000 µmol/l) of unconjugated bilirubin. | Bilirubin (conjugated and unconjugated): No significant interference found up to 30 mg/dl (513 µmol/l) |

Thermo Fisher Scientific Oy

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

[phone] tel
[phone] fax

Y-tunnus 092 i 547-0
VAT No FI092 i 5470
Domicile Helsinki

www.ibermo.com

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# 100 11

Thermo Fisher Scientific Oy

Ratastie 2
P.C). Box 100
FIN-01621 Vantaa
Finland

[phone] tel
[phone] fax

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

ww.rhermo.com

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

[phone] tel
[phone] fax

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

:

www.thermo.com

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The bird is positioned to the right of a circular border containing the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific Oy c/o Mr. Päivi Sormunen Vice President of Reagent Business Development and QRC Clinical Diagnostics Finland Ratastie 2, P.O. Box 100 FIN-01621 Vantaa, Finland

OCT 3 2007

k071580 Re:

> Trade Name: AST/GOT (IFCC), Auxiliary Product: Pyridoxal Phosphate eCal, Nortrol, Abtrol Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system. Regulatory Class: Class II Product Code: CIT, JIX, JJY Dated: August 30, 2007 Received: September 14, 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 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.

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): K071580 AST / GOT (IFCC) Device Name: Auxiliary product: Pyridoxal Phosphate eCal Nortrol Abtrol

Indication For Use:

## AST / GOT (IFCC)

The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease

## Auxiliary product: Pyridoxal Phosphate

Auxiliary reagent for in vitro diagnostic use in the quantitative determination of AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

## eCal.

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests using methods defined by Thermo Fisher Scientific Oy

## Nortrol

For in viro diagnostic use for quantitative testing on 760 instrument. Nortrol is a control serum to monitor 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 T60 instrument. Abtrol is a control serum to monitor precision of the analytes listed in the separate Abtrol value sheet. The given yalues are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Ov.

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

Carl C. Benson

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

510(k) K071580