← Product Code [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT) · K080485

# ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485)

_Diasys Diagnostics Systems GmbH · CIT · Dec 4, 2008 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K080485

## Device Facts

- **Applicant:** Diasys Diagnostics Systems GmbH
- **Product Code:** [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT.md)
- **Decision Date:** Dec 4, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1100
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

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. 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.

## Device Story

The DiaSys ASAT (GOT) FS assay is a two-reagent, in vitro diagnostic test for measuring aspartate aminotransferase (AST) activity in human serum and lithium heparin plasma. The assay utilizes a modified IFCC reference method involving the reduction of NADH to NAD; pyridoxal-5-phosphate (P-5-P) is added to stabilize transaminases and prevent falsely low values in patients with liver or heart disease. The system includes TruCal U for calibration and TruLab N/P controls for quality monitoring. The assay is performed on the Hitachi 917 clinical chemistry analyzer. Healthcare providers use the quantitative AST results to assist in the diagnosis and management of liver and heart conditions. The device is intended for professional clinical laboratory use.

## Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=80); total CVs 1.22-5.06%. Linearity verified 0-900 U/L (reportable 7-700 U/L). Interference studies per CLSI EP7-A2 showed significant hemoglobin interference; hemolyzed samples contraindicated. Method comparison (N=130-139) against predicate using Passing Bablok regression showed high correlation (R2 > 0.999).

## Technological Characteristics

Two-reagent enzymatic assay; modified IFCC reference method. Uses pyridoxal-5-phosphate (P-5-P) activation. Lyophilized human serum matrix for calibrators and controls. Designed for the Hitachi 917 clinical chemistry analyzer. Storage at 2-8°C. Quantitative measurement range: 7-700 U/L.

## Regulatory 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

- Roche/Hitachi AST (ASAT/GOT) Aspartate aminotransferase acc. to IFCC with/without pyridoxal phosphate activation ([K924244](/device/K924244.md))
- Roche Calibrator for automated systems (C.f.a.s.) ([K990460](/device/K990460.md))
- Roche Precinorm Universal Plus and Precipath Universal Plus controls ([K042389](/device/K042389.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k080485

B. Purpose for Submission:
New device

C. Measurand:
Aspartate Amino Transferase (AST/SGOT)

D. Type of Test:
Quantitative, enzymatic

E. Applicant:
DiaSys Diagnostic Systems GmbH

F. Proprietary and Established Names:
ASAT (GOT) FS assay
TruCal U calibrator (calibrator material for the ASAT FS assay)
TruLab N and TruLab P Controls (control material for the ASAT FS assay)

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  Aspartate amino transferase (AST/SGOT) Test System (CIT) | Class II | 21 CFR 862.1100, Aspartate amino transferase (AST/SGOT) Test System | 75 Clinical Chemistry (CH)  |
|  Product Code | Classification | Regulation Section | Panel  |
|  Calibrator, Secondary (JIT) | Class II | 21 CFR 862.1150, Calibrator | 75 Clinical Chemistry (CH)  |
|  Product Code | Classification | Regulation Section | Panel  |
|  Single analyte control (JIX) | Class I | 21 CFR 862.1660, Quality Control Material (assayed and unassayed) | 75 Clinical Chemistry (CH)  |

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H. Intended Use:

1. Intended use(s):

See Indication for use below.

2. Indication(s) for use:

ASAT (GOT) FS assay

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.

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.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Roche Hitachi 917 analyzer

I. Device Description:

The DiaSys aspartate amino transferase (AST) assay is supplied as ready-to-use, liquid reagents with two formats (with or without pyridoxal-5'-phosphate). The first format is a two reagents format without P-5-P, which consists of reagent A and reagent B. The second format is a three reagents format, which consists of reagent A, reagent B, and a third optional reagent, which is pyridoxal-5'-phosphate (P-5-P). For the two-reagent method, the entire contents of reagent B are added to reagent A and are mixed well before use. For the three-reagent method, reagent A, reagent B and pyridoxal-5'-phosphate are not mixed together. Components included in the reagents are listed below:

1. Reagent A (Enzyme reagent) contains Tris buffer, pH 7.65 (110 mmol/L), L-Aspartate (320 mmol/L), lactate dehydrogenase (≥ 1200 U/L), and malate dehydrogenase (≥ 800 U/L).
2. Reagent B (substrate) contains 2-Oxoglutarate (65 mmol/L) and NADH (1 mmol/L).

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3. Liquid pyridoxal-5'-phosphate contains Good's buffer, pH 9.6 (100 mmol/L) and pyridoxal-5'-phosphate (13 mmol/L).

The TruCal U calibrator is a lyophilized calibrator based on human serum and contains purified additives from human and animal origin, purified pharmaceuticals, and chemical additives. The AST added origins of porcine heart.

The TruLab N and TruLab P controls are lyophilized human-based control serum and contains purified human and animal components, purified drugs and non-organic components.

Human source materials was tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HBsAg, and HCV.

# J. Substantial Equivalence Information:

1. Predicate device names(s):

Roche AST assay, Roche calibrator for automated systems (C.f.a.s), and Roche Precinorm Universal Plus and Precipath Universal Plus controls

2. Predicate 510(k) number(s):

k924244, k990460, k042389

3. Comparison with predicate:

DiaSys ASAT FS assay:

|  Similarities and Differences  |   |   |
| --- | --- | --- |
|  Item | DiaSys AST assay (candidate device) | Roche AST assay (predicate device)  |
|  Intended Use | The AST/ GOT (IFCC) assay is intended for quantitative in vitro 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 | In vitro test for the quantitative determination of aspartate amino transferase (AST) in human serum or plasma on Roche clinical chemistry analyzers  |
|  Assay protocol | 1.) 2-reagent method: Modified IFCC reference method (without P-5-P) 2.) 3-reagent method: Original IFCC reference method (with P-5-P) | Same  |

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|  Traceability | Standardized against the original IFCC formulation with and without pyridoxal phosphate | Same  |
| --- | --- | --- |
|  Methodology | Enzymatic | Enzymatic  |
|  Analyzer | Roche Hitachi 917 analyzer | Roche auto chemistry analyzer  |
|  Calibrator | One level | Two levels:
1) A: Phosphate buffer
2) B: Gravimetrically prepared S-adenosyl-L-homocysteine (SAH) in phosphate buffer at defined concentrations.  |
|  Sample types | Serum or Heparin Plasma | Serum, EDTA or Heparin Plasma  |
|  Reportable range | 7-700 U/L | 4-800 U/L  |

## TruCal U Calibrator:

|  Similarities and differences  |   |   |
| --- | --- | --- |
|  Item | Candidate Device | Predicate Device  |
|  Intended use | 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 use in the calibration of the quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets  |
|  Form | Lyophilized human serum | Same  |
|  Levels | Single | Same  |

## TruLab N and TruLab P Controls:

|  Similarities and differences  |   |   |
| --- | --- | --- |
|  Item | Candidate Device | Predicate Device  |
|  Intended use | 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 | For use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets  |
|  Form | Lyophilized human serum | Same  |

## K. Standard/Guidance Document Referenced (if applicable):

CLSI Guideline, EP5-A2 Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline Second edition (2004)

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CLSI Guideline, EP6-A Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline

CLSI Guideline, EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second edition

CLSI Guideline, EP9-A2 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second edition

CLSI Guideline, EP17-A Protocols for Demonstration, Verification, and Evaluation of Limits of Detection and Quantitation; Approved Guideline

## L. Test Principle:

AST catalyses the transfer of amino group from aspartate to oxoglutarate during the formation of glutamate and oxaloacetate. Oxaloacetate is reduced to malate by malate dehydrogenase (MDH). During this conversion, an equivalent amount of NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is directly proportional to the activity of AST in serum.

Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

A precision study was evaluated according to CLSI EP5-A guideline using three levels of serum samples. Samples were run twice per day in duplicate for 20 days on the Hitachi 917 analyzer (N=80). Precision data was calculated and summarized below:

Precision for method with P-5-P on the Hitachi 917 analyzer:

|  Levels | Mean (U/L) | Within run (%CV) | Between run (%CV) | Total precision (%CV)  |
| --- | --- | --- | --- | --- |
|  Sample 1 | 42.0 | 1.08 | 2.42 | 2.84  |
|  Sample 2 | 83.2 | 1.12 | 3.26 | 4.41  |
|  Sample 3 | 541 | 0.93 | 0.14 | 1.22  |

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Precision for method without P-5-P on the Hitachi 917 analyzer:

|  Levels | Mean (U/L) | Within run (%CV) | Between run (%CV) | Total precision (%CV)  |
| --- | --- | --- | --- | --- |
|  Sample 1 | 29.7 | 1.32 | 3.19 | 3.81  |
|  Sample 2 | 74.0 | 1.13 | 3.95 | 5.06  |
|  Sample 3 | 560 | 0.83 | 0.57 | 1.30  |

b. Linearity/assay reportable range:

A linearity study was evaluated across the entire measuring range. A low serum sample and a high serum sample were mixed to prepare 11 different concentrations of AST and then diluted with saline (the recommended diluent). Each concentration was tested in quadruplicate and range tested was 0-900 U/L for both methods (with P-5-P and without P-5-P) on the Hitachi 917 analyzer. Values were plotted for the expected concentrations (X) versus the observed concentrations (Y) and an appropriate line fitted by Passing Bablok method was calculated as follows:

With P-5-P:  $y = 0.997x + 0.046$ ,  $r = 0.9998$

Without-P-5-P:  $y = 0.999x + 0.001$ ,  $r = 0.9997$

The data provided supports the sponsor's claim that the assay has a reportable range of 7-700 U/L.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

The DiaSys ASAT (GOT) FS assay is standardized against IFCC reference method. The two reagent format without P-5-P is traceable to the modified IFCC formulation while the three reagent format with P-5-P is traceable to the original IFCC formulation.

Value Assignment:

The concentration of the TruCal U calibrator, TruLab N and P controls are lot-specific and given in the value sheet of the corresponding lot. The value was determined using either the two reagent method without P-5-P or the three reagent method with P-5-P and by using the reagents specified by the method formats. Determinations of the value were performed under an internal protocol against a TruCal U master lot.

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Stability of the TruCal U calibrator, TruLab N and P controls:

The shelf life and open vial stability testing protocols for the calibrators and controls and the acceptance criteria were described and found to be acceptable.

d. Detection limit:

A detection limit study was evaluated according to CLSI EP17-A guideline. The Limit of Blank (LoB) is defined as the highest value expected to see in a series of results on a sample that contains no analyte. The Limit of Detection (LoD) is the smallest amount that the method can reliably detect to determine presence or absence of an analyte. The Limit of Quantitation (LoQ) is the smallest amount the assay can reliably measure quantitatively and at which the uncertainty of the observed test result is less than or equal to the goal set (total error of a $\mathrm{CV} \leq 20\%$). LoB was determined by running a blank sample 60 times on the Hitachi 917 analyzer. The limit of detection (LoD) and limit of quantitation (LoQ) were determined by running 4 low samples 60 times on the Hitachi 917. The detection limits are calculated as follows:

For method with P-5-P: $\mathrm{LoB} = 0.78 \mathrm{U/L}$, $\mathrm{LoD} = 1.26 \mathrm{U/L}$, and $\mathrm{LoQ} = 1.26 \mathrm{U/L}$

For method without P-5-P: $\mathrm{LoB} = 1.30 \mathrm{U/L}$, $\mathrm{LoD} = 1.84 \mathrm{U/L}$, and $\mathrm{LoQ} = 1.84 \mathrm{U/L}$

The reportable range for the assay is $7 - 700\mathrm{U/L}$.

e. Analytical specificity:

An interference study was evaluated to determine the effect of common interference substances according to the CLSI EP7-A2 guideline. Two levels of human serum pools with different AST were tested. The following interference substances were tested: conjugated bilirubin, unconjugated bilirubin, hemoglobin, ascorbic acid and triglyceride. Stock solutions of the above chemicals were prepared and spiked into the tested samples with different concentrations. The % bias was calculated based on the differences between the spiked sample and the pool sample. The sponsor's acceptance criterion was $< 10\%$ bias for the interferences to be considered as not significant. Results of the hemoglobin study demonstrated significant interference for hemoglobin; thus, the sponsor recommends that user not to use hemolyzed samples for this test and this information is provided in the labeling.

Results of the interference studies of various potential interferents were shown as follows:

For method without P-5-P:

Conjugated bilirubin: Interference $\leq 10\%$ for up to $60~\mathrm{mg/dL}$ conj. bilirubin

Unconjugated bilirubin: Interference $\leq 10\%$ for up to $24~\mathrm{mg/dL}$ unconj.bilirubin

Triglycerides: Interference $\leq 10\%$ for up to $400~\mathrm{mg/dL}$ triglycerides

Ascorbic acid: Interference $\leq 10\%$ for up to $30~\mathrm{mg/dL}$ ascorbic acid

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For method with P-5-P:

Conjugated bilirubin: Interference  $\leq 10\%$  for up to  $36~\mathrm{mg / dL}$  conj. bilirubin

Unconjugated bilirubin: Interference  $\leq 10\%$  for up to  $24~\mathrm{mg / dL}$  unconj.bilirubin

Triglycerides: Interference  $\leq 10\%$  for up to  $400~\mathrm{mg / dL}$  triglycerides

Ascorbic acid: Interference  $\leq 10\%$  for up to  $30~\mathrm{mg / dL}$  ascorbic acid

f. Assay cut-off:

Not applicable

# 2. Comparison studies:

# a. Method comparison with predicate device:

A method comparison study was performed using the DiaSys ASAT FS assay (candidate device) for both methods (with and without P-5-P) according to CLSI EP9-A2 guideline. Patient serum and lithium heparin plasma samples were used to evaluate against the Roche AST assay (predicate device). In order to cover the hard-to-find sample range some of the samples were spiked. All testing were performed using the Hitachi 917 analyzer. The method used to fit the linear regression line was Passing Bablok. A summary of the regression statistics is provided below:

|  Methods | N | Sample range | Slope | Intercept | R2  |
| --- | --- | --- | --- | --- | --- |
|  Serum with P-5-P method | 139 | 20-639 | 0.975 | 4.414 | 0.9999  |
|  Serum without P-5-P method | 139 | 12-654 | 1.065 | 0.215 | 0.9994  |
|  Heparin plasma with P-5-P method | 131 | 17-692 | 0.994 | 2.286 | 0.9998  |
|  Heparin plasma without P-5-P method | 130 | 12-649 | 1.081 | 0.466 | 0.9998  |

# b. Matrix comparison:

See method comparison study for both matrices in 2a. above

The sponsor recommends serum and lithium heparin plasma as samples to use.

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3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Reference ranges are provided in the labeling as follows: Male is < 35 U/L and Female is < 31 U/L for both with and without P-5-P methods (according to the literature that the sponsor cited)*
* IFCC 2002/6: IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C, Part. 5. Reference Procedure for the Measurement of Catalytic Concentrations of Aspartate Aminotransferase, Clin.Chem.Lab.Med. 2002, 40(7): 725-733.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K080485](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K080485)

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