The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

Device Description

The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation:

L-Aspartate + 2-Oxoglutarate L-Glutamate + Oxalacetate

Oxalacetate + NADH + H' < MDH > L-Malate + NAD*

Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients .

TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

AI/ML Overview

The furnished document is a 510(k) premarket notification for an in vitro diagnostic device, the DiaSys ASAT (GOT) FS assay, TruCal U calibrator, and TruLab N and TruLab P controls. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive independent clinical study data with predefined acceptance criteria as might be seen for novel devices.

Therefore, the information regarding acceptance criteria and a detailed study proving the device meets these criteria is limited and primarily presented in the context of comparison to the predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the studies in the same way a clinical trial would. Instead, it presents performance characteristics and compares them to the predicate device, implying that equivalence to the predicate's performance is the de facto acceptance criterion.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (DiaSys ASAT (GOT) FS assay)
Intended Use	Equivalent to predicate device.	The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. (Similar to predicate, though predicate includes EDTA plasma).
Assay Protocol	Equivalent to predicate device.	2-reagent method: modified IFCC reference method (without P-5-P) or 2-reagent method: IFCC reference method (P-5-P concentrate mixed into R1). (Similar to predicate, predicate uses P-5-P tablet).
Traceability	Standardized against IFCC formulation.	Standardized against the original IFCC formulation with and without pyridoxal phosphate. (Same as predicate).
Reagent Storage	Comparable shelf life and on-board stability to predicate.	Storage: 2-8°C, Shelf Life R1 - 15 months, R2 - 15 months, P-5-P - 24 months. On Board R1(no P-5-P) - 4 weeks, R1(with P-5-P) - 6 days, R2 - 4 weeks. (Comparable but some differences to predicate).
Instrument	Hitachi 917.	Hitachi 917. (Same as predicate).
Measuring Range	Comparable to predicate device.	7-700 U/L. (Predicate: 4-800 U/L).
Expected Values	Consistent with clinical understanding and predicate device.	With P-5-P activation: Women <31 U/L, Men <35 U/L. Without P-5-P activation: Women <31 U/L, Men <35 U/L. (Predicate: Men up to 40 U/L, Women up to 32 U/L).
Precision	Comparable to predicate device.	With P-5-P (N=80): Within Run (Low serum: 1.08%, Middle serum: 1.12%, High serum: 0.93%), Between Run (Low serum: 2.42%, Middle serum: 3.26%, High serum: 0.14%), Total (Low serum: 2.84%, Middle serum: 4.41%, High serum: 1.22%). Without P-5-P (N=80): Within Run (Low serum: 1.32%, Middle serum: 1.13%, High serum: 0.83%), Between Run (Low serum: 3.19%, Middle serum: 3.85%, High serum: 0.57%), Total (Low serum: 3.81%, Middle serum: 5.06%, High serum: 1.30%). (Predicate: Within Run serum: 1.8%, Low: 2.1%, High: 1.1%; Between Run serum: 3.2%, Low: 3.2%, High: 1.8%). Numbers appear comparable or better.
Method Comparison	Strong correlation with a commercially available test (predicate).	With P-5-P: $y = 0.975 x + 4.414$ U/L; r2 = 0.9999. (139 serum samples, range 20-639 U/L). Without P-5-P: $y = 1.065 x + 0.215$ U/L; r2 = 0.9994. (139 serum samples, range 12-654 U/L). (Predicate: Passing/Bablock: $y=1.01x-0.93$, Linear regression $y=1.01x-0.75$, r=1.000 for 91 samples, range 11-690 U/L). The r-squared values for the subject device are very high, indicating excellent agreement.
Interferences	Recovery within ± 10% of initial value.	Without P-5-P: Interference < 10% by: Ascorbic acid up to 30 mg/dL, Conj. Bilirubin up to 60 mg/dL, Unconj. Bilirubin up to 24 mg/dL, Triglycerides up to 400 mg/dL. With P-5-P: Interference < 10% by: Ascorbic acid up to 30 mg/dL, Conj. Bilirubin up to 36 mg/dL, Unconj. Bilirubin up to 24 mg/dL, Triglycerides up to 400 mg/dL. (Predicate criterion: Hemolysis: 25 mg/dL, Icterus: 60 mg/dL, Lipemia: L index of 500). The ranges for non-interference are reported, showing the device meets these criteria for the tested interferents.

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

Precision Test Set Sample Size: N=80 for both "With P-5-P" and "Without P-5-P" conditions. The N=80 refers to the total number of measurements, likely across different runs and samples (e.g., low, middle, high serum levels).
Method Comparison Test Set Sample Size: 139 serum samples.
Data Provenance: Not explicitly stated (e.g., country of origin). The document does not specify if the data is retrospective or prospective. Given the nature of a 510(k) for an in vitro diagnostic, these are typically laboratory-based performance studies done on collected human samples.

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

This section is not applicable for this type of in vitro diagnostic device. The "ground truth" for the ASAT assay is the quantitative measurement of enzyme activity, which is established by comparison to a reference method (IFCC formulation) or a commercially available, well-established method (the predicate device) on clinical chemistry analyzers, not by expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This section is not applicable for this type of in vitro diagnostic device, as the performance is based on quantitative measurements rather than qualitative interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically relevant for diagnostic imaging systems where human readers interpret medical images with and without AI assistance. This device is an in vitro diagnostic assay that generates quantitative numerical results, not images for human interpretation.

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

Yes, the performance studies described (Precision, Method Comparison, Interferences) report the standalone performance of the DiaSys ASAT (GOT) FS assay. This device is an automated assay on a clinical chemistry analyzer (Hitachi 917), meaning its performance is inherently standalone (algorithm/reagent/instrument only) once the sample is loaded. There isn't a "human-in-the-loop" aspect to the analytical measurement process itself, beyond the initial sample preparation and loading.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in these studies is established through either:

Reference Method Comparison: The ASAT values are traceable to the International Federation of Clinical Chemistry (IFCC) formulation.
Comparative Device Measurement: For method comparison, the results of the subject device (DiaSys ASAT (GOT) FS assay) are compared against a "commercially available test (x)" on the Hitachi 917, which is the predicate device or a similar established method. This established method's results serve as the comparative "truth."

8. The Sample Size for the Training Set

The document is a 510(k) for a chemical assay, not an AI/machine learning device. Therefore, there is no concept of a "training set" in the context of machine learning. The "development" of the assay involves chemical formulation and calibration, which are different from training an algorithm.

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

As there is no training set for an algorithm, this question is not applicable. The "ground truth" for calibrator values is established through traceability to IFCC standards.

Summary

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DEC 0 4 2008

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: K080485.

A. Introduction:

According to the requirements of 21 CFR 807.92 the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

B. Submitter's information

Name:	DiaSys Diagnostic Systems GmbH
Address:	Alte Strasse 965558 HolzheimGermanyTelephone - 011 49 6432 9146 0Fax - 011 49 6432 9146 32www.diasys-diagnostics.com
Contact person:	Stephanie Klein, Import/Export Manager
Date of Preparation:	November 12, 2008

C. Device name

Proprietary name:	ASAT (GOT) FS assay
Common name:	Aspartate amino transferase (AST/SGOT) test system
Classification:	862.1100
Class:	II
Product Code:	CIT

Proprietary name:	TruCal U calibrator
Common Name:	Calibrator, Secondary
Classification:	862.1150
Class:	II
Product Code:	JIT

Proprietary name:	TruLab N and TruLab P controls
Common Name:	Quality control material (assayed and unassayed)
Classification:	862.1660
Class:	I
Product Code:	JJX

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D. Predicate Device

Roche/Hitachi AST (ASAT/GOT) Aspartate aminotransferase acc. to IFCC with/without pyridoxal phosphate activation (K924244)

Roche Calibrator for automated systems (C.f.a.s.) (K990460).

Roche Precinorm Universal Plus and Precipath Universal Plus controls (K042389).

E. Device Description and Explanation of the Test

The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation:

L-Aspartate + 2-Oxoglutarate L-Glutamate + Oxalacetate

Oxalacetate + NADH + H' < MDH > L-Malate + NAD*

Thomas L. Alanine ammotransferase (ALT), Aspartate aminotransferase (AST). In: Thomas L, editor. Clinical Laboratory Diagnostics. 1ª ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 55-65.

TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

F. Intended Use / Indications For Use

ASAT (GOT) FS

TruCal U

For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

TruLab N and TruLab P Controls

For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. Trul ab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

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G. Substantial Equivalence

Similarities and Differences

The similarities and differences between the predicate and subject devices are provided below. Briefly, the ASAT assays, calibrators, and control material are similar with respect to intended use, functionality, and operating principle. Both assays are intended to operate as in viro quantitative tests for the measurement of ASAT (GOT) on the Hitachi 917 instrument. Both calibrators are intended to calibrate their respective ASAT assays. Both control materials are intended to monitor the accuracy and precision of their respective ASAT assays.

The main differences are that the subject assay device is indicated only for human serum and lithium heparin plasma while the predicate assay device is indicated for human serum and both EDTA and Heparin plasma, the subject callbrator is indicated only for ASAT on the Hitachi 917 instrument while the predicate calibrator is a multi-analyte calibrator that can be used on a variety of instruments, and the subject controls are indicated only for ASAT on the Hitachi 917 instrument while the predicate controls are multi-analyte controls that can be used on a variety of instruments.

Conclusion

In summary, the DiaSys Diagnostic Systems ASAT (GOT) FS assay, TruCal U calibrator, and TruLab N and TruLab P controls devices described in this 510(k) are, in our opinion, substantially equivalent to the predicate devices. They have the same intended use and technological characteristics as the predicates, and raise no new issues of safety or effectiveness.

ComparativeCharacteristic or Feature	Subject DeviceDiaSys ASAT (GOT) FS assay(K080485)	Predicate DeviceRoche/Hitachi 917 AST(ASAT/GOT)(K924244)
Intended Use / IndicationsFor Use	The ASAT (GOT) FS assay is intendedfor quantitative in vitro diagnosticdetermination of the activity of theenzyme aspartate amino transferase(AST) in human serum and lithiumheparin plasma on the Hitachi 917instrument. Measurement ofaspartate amino transferase levelsaids in the diagnosis and treatment ofcertain types of liver and heartdisease.	In vitro test for the quantitativedetermination of aspartateaminotransferase (AST) in humanserum or plasma on Roche clinicalchemistry analyzers.
Assay Protocol	2-reagent method: modified IFCCreference method (without P-5-P)2-reagent method: IFCC referencemethod (P-5-P concentrate mixed intoR1)	2-reagent method: modified IFCCreference method (without P-5-P)2-reagent method: IFCC referencemethod (P-5-P tablet mixed intoR1)
Traceability	Standardized against the originalIFCC formulation with and withoutpyridoxal phosphate.	same
ComparativeCharacteristic or Feature	Subject DeviceDiaSys ASAT (GOT) FS assay(K080485)	Predicate DeviceRoche/Hitachi 917 AST(ASAT/GOT)(K924244)
Reagent Storage	Storage:2-8°CShelf LifeR1 - 15 monthsR2 - 15 monthsP-5-P - 24 monthsOn BoardR1(no P-5-P) - 4 weeksR1(with P-5-P) - 6 daysR2 - 4 weeks	Storage:2-8°CShelf LifeR1 - up to expiration dateR2 - up to expiration dateP-5-P - up to expiration dateOn BoardR1(no P-5-P) - 28 daysR1(with P-5-P) - 6 daysR2 - 90 days
Instrument	Hitachi 917	same
Measuring Range	7-700 U/L	4-800 U/L
Expected Values	With pyridoxal-5-phosphate activationWomen<31 U/LMen<35 U/LWithout pyridoxal-5-phosphate activationWomen<31 U/LMen<35 U/L	Men:up to 40 U/LWomen:up to 32 U/L
Precision	With P-5-P (N=80)Within RunLow serum: 1.08%Middle serum: 1.12%High serum: 0.93%Between RunLow serum: 2.42%Middle serum: 3.26%High serum: 0.14%TotalLow serum: 2.84%Middle serum: 4.41%High serum: 1.22%Without P-5-P (N=80)Within RunLow serum: 1.32%Middle serum: 1.13%High serum: 0.83%Between RunLow serum: 3.19%Middle serum: 3.85%High serum: 0.57%TotalLow serum: 3.81%Middle serum: 5.06%High serum: 1.30%	Within Runserum: 1.8%Low: 2.1%High: 1/1%Between Runserum: 3.2%Low: 3.2%High: 1.8%
Method Comparison	With P-5-PA comparison between DiaSys ASAT(GOT) FS with P-5-P (y) and acommercially available test (x) on Hitachi917 using 139 serum samples in a rangeof 20-639 U/L gave following results:$y = 0.975 x + 4.414$ U/L; r2 = 0.9999.Without P-5-PA comparison between DiaSys ASAT(GOT) FS without P-5-P (y) and acommercially available test (x) on Hitachi917 using 139 serum samples in a rangeof 12-654 U/L gave following results:$y = 1.065 x + 0.215$ U/L; r2 = 0.9994.	A comparison of the 10 $\mu$ L samplevolume AST assay (y) with the 20 $\mu$ Lassay using AST IFCC reagent fromRoche on a Roche/Hitachi 911analyzer gave the followingcorrelation (U/L):Passing/Bablock:$y=1.01x-0.93$Linear regression$y=1.01x-0.75$$r=1.000$Number of samples measured=91Activity range: 11-690 U/L

Comparison of Similarities and Differences

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ComparativeCharacteristic or Feature	Subject DeviceDiaSys ASAT (GOT) FS assay(K080485)	Predicate DeviceRoche/Hitachi 917 AST(ASAT/GOT)(K924244)
Interferences	Without P-5-P	Criterion: Recovery within ± 10% of initial value.Hemolysis: 25 mg/dL.Icterus: 60 mg/dLLipemia: L index of 500
	Interference < 10%by Level ASAT[U/L] Ascorbic acid up to30 mg/dL 25.4 58.1 Conj. Bilirubin up to60 mg/dL 22.3 55.8 Unconj. Bilirubin up to24 mg/dL 22.4 54.1 Triglycerides up to400 mg/dL 23.3 78.2
	With P-5-P
	Interference < 10%by Level ASAT[U/L] Ascorbic acid up to30 mg/dL 35.3 67.8 Conj. Bilirubin up to36 mg/dL 31.2 66.9 Unconj. Bilirubin up to24 mg/dL 31.5 65.9 Triglycerides up to400 mg/dL 32.8 78.2
	The lipid interference limit was assessed using an artificial lipid solution and does not necessarily correspond to the interference limit by native triglycerides. The presence of hemoglobin in serum indicates destruction of erythrocytes with release of

. . .

ComparativeCharacteristic or Feature	Subject DeviceDiaSys TruCal U calibrator(K080485)	Predicate DeviceRoche Calibrator for automatedsystems(K990460)
Intended Use/ IndicationsFor Use	For in vitro diagnostic use on theHitachi 917 instrument. TruCal U isused as a calibrator for the DiaSysASAT (GOT) FS assay.	The Calibrator for automatedsystems (C.f.a.s.) is for use in thecalibration of the quantitativeRoche methods on Roche clinicalchemistry analyzers as specifiedin the value sheets.
Matrix	Lyophilized human serum	Lyophilized human serum
Levels	Single level	same
Stability	Unopened: 17 months at 2-8°COpened: 2 days at 2-8°C8 hours at 25 °C4 weeks at -20 °C(frozen only once)	Unopened: Stable at 2-8°C untilexpiration dateOpened: 2 days at 2-8 °C
Traceability	ASAT target values in TruCal U aretraceable to the InternationalFederation of Clinical Chemistry(IFCC)	Traceability of the target values isgiven in the respectiveinstructions for use of the systemreagents.

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ComparativeCharacteristic or Feature	Subject DeviceDiaSys TruLab N and TruLab Pcontrols(K080485)	Predicate DeviceRoche Precinorm U andPrecipath U controls(K042389)
Intended Use / IndicationsFor Use	For in vitro diagnostic use forquantitative testing on the Hitachi 917instrument. TruLab N and TruLab Pcontrol sera are used to monitoraccuracy and precision for the DiaSysASAT (GOT) FS assay.	Precinorm U Plus / Precipath UPlus are for use in quality controlby monitoring accuracy andprecision for the quantitativemethods as specified in theenclosed value sheet
Matrix	Lyophilized human serum	same
Stability	Unopened: 36 months at 2-8°COpened: 2 days at 2-8°C8 hours at 25 °C4 weeks at -20 °C(frozen only once)	Unopened: Until expiration date at2-8°C.Opened:12 hours at 15-25°C5 days at 2-8°C4 weeks at -15 to -25°C whenfrozen once

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스

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DiaSys Diagnostic Systems GmbH c/o Ms. Stephanie Klein Import/Export Manager Alte Strasse 9 D-65558 Holzheim, Germany

DEC 0 4 2008

Re: K080485

Trade/Device Name: ASAT (GOT) FS assay, TruCal U calibrator & TruLab N and TruLab P controls

Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Code: CIT, JIT, JJX Dated: November 12, 2008 Received: November 14, 2008

Dear Ms. Klein:

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 1 ogally 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): K080485

Device Name: DiaSys ASAT (GOT) FS assay

Indication For Use:

ASAT (GOT) FS

The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

TruCal U

For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

TruLab N and TruLab P Controls

For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

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)

Carol C Benson

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

510(k) K080485

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.