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.

Device Description

Not Found

AI/ML Overview

The provided submission describes an in vitro diagnostic device (IVD) for the quantitative determination of aspartate aminotransferase (AST/GOT) activity. It is not an AI/ML powered device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set) are not applicable.

Here's the breakdown of the acceptance criteria and study information provided for the AST/GOT (IFCC) device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to those of the predicate device (Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)). The goal is to demonstrate "substantial equivalence."

Attribute / Acceptance Criteria (Implied by Predicate)	New Device (AST/GOT (IFCC)) Performance	Predicate Device (Bayer ADVIA IMS AST assay) Performance
Intended Use	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.	For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma on the ADVIA Chemistry systems. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease.
Indication 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.	See intended use.
Assay Protocol	1-reagent method: Modified IFCC reference method (without PyP)3-reagent method: IFCC reference method	1-reagent method: Modified IFCC3-reagent method: IFCC
Traceability/Standardization	The AST/ GOT (IFCC) 1-reagent method is traceable to the molar absorbance coefficient of NADH.The AST/ GOT (IFCC) 3-reagent method is traceable to the IFCC reference method.	The ADVIA AST and AST P5P method standardization is traceable to the IFCC reference method via patient sample 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/lFemale: < 31 U/l	1-reagent method: < 34 U/l3-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/l3-reagent method: 4 - 300 U/l	0 - 1000 U/l
Precision (Within run, Between run, Total CV%)	1-reagent method:Within run: 38 U/l (SD=0.5, CV=1.4%), 101 U/l (SD=0.9, CV=0.9%), 189 U/l (SD=1.0, CV=0.5%)Between run: 101 U/l (SD=0.5, CV=0.5%), 189 U/l (SD=1.1, CV=0.6%)Total: 38 U/l (SD=0.9, CV=2.4%), 101 U/l (SD=2.0, CV=2.0%), 189 U/l (SD=3.2, CV=1.7%)3-reagent method:Within run: 37 U/l (SD=0.6, CV=1.5%), 124 U/l (SD=1.3, CV=1.1%), 191 U/l (SD=1.0, CV=0.5%)Between run: 37 U/l (SD=0.4, CV=1.0%), 124 U/l (SD=1.4, CV=1.1%), 191 U/l (SD=1.2, CV=0.6%)Total: 37 U/l (SD=1.0, CV=2.7%), 124 U/l (SD=2.5, CV=2.0%), 191 U/l (SD=2.9, CV=1.5%)	1-reagent method:Within run: 42 U/l (SD=0.8, CV=2.1%), 188 U/l (SD=1.3, CV=0.7%)Total: 42 U/l (SD=1.3, CV=3.3%), 188 U/l (SD=4.1, CV=2.3%)3-reagent method:Within run: 50 U/l (SD=0.6, CV=1.5%), 195 U/l (SD=1.3, CV=1.1%)Total: 50 U/l (SD=1.0, CV=2.7%), 195 U/l (SD=2.5, CV=2.0%)
Method Comparison (Correlation with Predicate/Reference Method)	1-reagent method: $y = 0.95x - 2.0$, R = 0.992 (Range 12 to 307 U/L, N=83)3-reagent method: $y = 0.94x + 1.3$, R = 0.994 (Range 15 to 408 U/L, N=84)	Comparison with Technicon DAX: $y = 0.99x - 6.3 U/l$, r = 0.999 (n = 111, range: 9.8 to 607.2 U/l)
Limitations (Interference)	1-reagent method:Lipemia: No interference up to 150 mg/dL (1.5 g/l) Intralipid.Hemolysate: Avoid hemolyzed samples.Bilirubin, conjugated: No interference up to 35 mg/dL (600 µmol/l).Bilirubin, unconjugated: No interference up to 35 mg/dL (600 µmol/l).3-reagent method:Lipemia: No interference up to 150 mg/dL (1.5 g/l) Intralipid.Hemolysate: Avoid hemolyzed samples.Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l).Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l).	1-reagent method:Lipemia (Intralipid): No significant interference up to 488 mg/dl.Hemolysate: Avoid hemolyzed samples.Bilirubin (conjugated and unconjugated): No significant interference up to 30 mg/dl (513 µmol/l).3-reagent method (AST Sample Concentration 65 U/l):Lipemia (Intralipid): No significant interference up to 488 mg/dl.Hemolysate: Avoid hemolyzed samples.Bilirubin (conjugated and unconjugated): No significant interference up to 30 mg/dl (513 µmol/l).

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

Test Set Sample Size:
- Method Comparison:
  - 1-reagent method: N = 83 (samples)
  - 3-reagent method: N = 84 (samples)
- Precision studies involve multiple measurements at different concentration levels, typically using control materials, but the exact number of individual patient samples for a "test set" demonstrating general performance is not explicitly stated beyond the method comparison.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Thermo Fisher Scientific Oy is based in Finland, it is plausible that some studies were conducted there. The context of a 510(k) submission implies that the data would be collected to support the safety and effectiveness for a US market.

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

This information is not applicable as this is an in vitro diagnostic (IVD) device (a laboratory test), not an AI/ML diagnostic imaging device that requires expert interpretation for ground truth. The "ground truth" for IVDs is typically established by reference methods or validated comparative analyses, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for an IVD device. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved.

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

This information is not applicable as this is an IVD device and not an AI/ML-powered diagnostic imaging or interpretation system that would involve human readers.

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

This information is not applicable as this is an IVD device, which inherently operates as a "standalone" test (algorithm only in the sense of the chemical reactions and measurement, without human interpretive input for the result itself). The device's performance is measured directly by its analytical accuracy, precision, and agreement with reference methods.

7. The Type of Ground Truth Used

The ground truth for this type of IVD device is established through:

Reference Methods: The device's performance is compared against established reference methods, such as the IFCC reference method or the predicate device (Bayer ADVIA IMS AST assay), which serves as a clinical comparison.
Traceability to Standards: The 1-reagent method is traceable to the molar absorbance coefficient of NADH, and the 3-reagent method is traceable to the IFCC reference method.
Known Concentrations: Precision studies involve testing samples with known or controlled concentrations of the analyte.

8. The Sample Size for the Training Set

This information is not applicable as this is a chemical assay, not an AI/ML model that requires a "training set." The assay method is based on established chemical principles and does not "learn" from data in the way an AI algorithm does.

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

This information is not applicable as there is no "training set" in the context of this IVD device.

Summary

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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 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:	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

JJY

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

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

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

www.themmo con

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E. Indications for use

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

+358 (9) 329 100 tel +358 (9) 3291 0500 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 1Attribute	New device #1	Predicate device #1
Intended Use	For in vitro diagnostic use in thequantitative determination ofaspartate aminotransferase (L-Aspartate: 2-OxoglutarateAminotransferase (AST), EC2.6.1.1) activity in human serumor plasma on T60 instrument.	For in vitro diagnostic use inthe quantitative determinationof aspartateaminotransferase activity inhuman serum and plasma onthe ADVIA Chemistrysystems. Such measurementsare used mainly to determinethe progress andprognosis of patients withmyocardial infarction and thediagnosis and monitoring ofliver disease.
Indication for Use	The AST/ GOT (IFCC) testsystem is intended forquantitative in-vitro diagnosticdetermination of the activity ofthe enzyme aspartate aminotransferase (AST) (also known asa serum glutamic oxaloacetictransferase or SGOT) in serumand plasma on T60 instrument.Measurement of aspartate aminotransferase levels aids in thediagnosis and treatment of certaintypes of liver and heart disease.	See intended use.
Assay Protocol	1-reagent method: ModifiedIFCC reference method (withoutPyP )3-reagent method: IFCCreference method	1-reagent method: ModifiedIFCC3-reagent method: IFCC
Traceability/Standardization	The AST/ GOT (IFCC) 1-reagentmethod is traceable to the molarabsorbance coefficient of NADH.The AST/ GOT (IFCC) 3-reagentmethod is traceable to the IFCCreference method.	The ADVIA AST and ASTP5P method standardization istraceable to the IFCC referencemethod via patient samplecorrelation.
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/lFemale: < 31 U/l	1-reagent method: < 34 U/l3-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/l3-reagent method: 4 - 300 U/l	0 - 1000 U/l
Precision	1-reagent method:Within runLevel 38 U/lSD= 0.5CV(%)= 1.4Level 101 U/lSD=0.9CV(%)= 0.9Level 189 U/lSD= 1.0CV(%)= 0.5Between runLevel 38 U/lSD= -CV(%)= -Level 101 U/lSD=0.5CV(%)= 0.5Level 189 U/lSD= 1.1CV(%)= 0.6TotalLevel 38 U/lSD= 0.9CV(%)= 2.4Level 101 U/lSD= 2.0CV(%)= 2.0Level 189 U/lSD= 3.2CV(%)= 1.7	1-reagent method:Within runLevel 42 U/lSD= 0.8CV(%)= 2.1Level 188 U/lSD=1.3CV(%)=0.7TotalLevel 42 U/lSD= 1.3CV(%)= 3.3Level 188 U/lSD= 4.1CV(%)= 2.33-reagent method:Within runLevel 50 U/lSD= 0.6CV(%)= 1.5Level 195 U/lSD=1.3CV(%)= 1.1TotalLevel 50 U/lSD= 1.0CV(%)= 2.7Level 195 U/lSD= 2.5CV(%)= 2.0
	3-reagent method:

	Within runLevel 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/LN = 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:No interference found up to 150 mg/dL (1.5 g/l) of Intralipid.	1-reagent method:Lipemia (from Intralipid):No significant interference found up to 488 mg/dl of Intralipid.
	Hemolysate:Avoid hemolyzed samples.	Hemolysate: Avoid hemolyzed samples
	Bilirubin, conjugated: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:No interference found up to 35 mg/dL (600 µmol/l) of unconjugated bilirubin.
	3-reagent method:
	Lipemia:No interference found up to 150 mg/dL (1.5 g/l) of Intralipid.	3-reagent method:(AST Sample Concentration 65 U/l)
	Hemolysate:Avoid hemolyzed samples.	Lipemia (from Intralipid):No significant interference found up to 488 mg/dl.
	Bilirubin, conjugated:No interference found up to 58 mg/dL (1000 µmol/l) of conjugated bilirubin.	Hemolysate: Avoid hemolyzed samples
	Bilirubin, unconjugated: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

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

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

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

ww.rhermo.com

{6}------------------------------------------------

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.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 (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): 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

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

Regulation Number and Section

§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(a)
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.(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.