Who is the manufacturer of ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

Diasys Diagnostics Systems GmbH filed the 510(k) submission for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485).

What is the FDA product code for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

CIT. It is classified under 21 CFR 862.1100 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K080485 · Diasys Diagnostics Systems GmbH · CIT · Dec 4, 2008 · Clinical Chemistry

Device Facts

Record ID	K080485
Device Name	ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
Applicant	Diasys Diagnostics Systems GmbH
Product Code	CIT · Clinical Chemistry
Decision Date	Dec 4, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1100
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of aspartate amino transferase (AST) activity in human serum and lithium heparin plasma to aid in the diagnosis and treatment of liver and heart disease. Used on the Hitachi 917 instrument.

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

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)

Related Devices

K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL · Thermofisher Scientific OY · Oct 3, 2007
K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) · Trace America, Inc. · Jan 30, 1998
K983131 — AST · Abbott Laboratories · Sep 28, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ # 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 9 65558 Holzheim Germany Telephone - 011 49 6432 9146 0 Fax - 011 49 6432 9146 32 www.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 | {1}------------------------------------------------ #### 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 <ASAT> 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 . 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. 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. #### F. Intended Use / Indications 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. 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. {2}------------------------------------------------ #### 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. | Comparative Characteristic or Feature | Subject Device DiaSys ASAT (GOT) FS assay (K080485) | Predicate Device Roche/Hitachi 917 AST (ASAT/GOT) (K924244) | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / 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. | In vitro test for the quantitative determination of aspartate aminotransferase (AST) in human serum or plasma on Roche clinical chemistry analyzers. | | Assay Protocol | 2-reagent method: modified IFCC reference method (without P-5-P) 2-reagent method: IFCC reference method (P-5-P concentrate mixed into R1) | 2-reagent method: modified IFCC reference method (without P-5-P) 2-reagent method: IFCC reference method (P-5-P tablet mixed into R1) | | Traceability | Standardized against the original IFCC formulation with and without pyridoxal phosphate. | same | | Comparative Characteristic or Feature | Subject Device DiaSys ASAT (GOT) FS assay (K080485) | Predicate Device Roche/Hitachi 917 AST (ASAT/GOT) (K924244) | | Reagent Storage | 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 | Storage: 2-8°C Shelf Life R1 - up to expiration date R2 - up to expiration date P-5-P - up to expiration date On Board R1(no P-5-P) - 28 days R1(with P-5-P) - 6 days R2 - 90 days | | Instrument | Hitachi 917 | same | | Measuring Range | 7-700 U/L | 4-800 U/L | | Expected Values | With pyridoxal-5-phosphate activation Women <31 U/L Men <35 U/L Without pyridoxal-5-phosphate activation Women <31 U/L Men <35 U/L | Men: up to 40 U/L Women: up to 32 U/L | | Precision | 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% | Within Run serum: 1.8% Low: 2.1% High: 1/1% Between Run serum: 3.2% Low: 3.2% High: 1.8% | | Method Comparison | With P-5-P A comparison between DiaSys ASAT (GOT) FS with P-5-P (y) and a commercially available test (x) on Hitachi 917 using 139 serum samples in a range of 20-639 U/L gave following results: $y = 0.975 x + 4.414$ U/L; r2 = 0.9999. Without P-5-P A comparison between DiaSys ASAT (GOT) FS without P-5-P (y) and a commercially available test (x) on Hitachi 917 using 139 serum samples in a range of 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 sample volume AST assay (y) with the 20 $\mu$ L assay using AST IFCC reagent from Roche on a Roche/Hitachi 911 analyzer gave the following correlation (U/L): Passing/Bablock: $y=1.01x-0.93$ Linear regression $y=1.01x-0.75$ $r=1.000$ Number of samples measured=91 Activity range: 11-690 U/L | ## Comparison of Similarities and Differences {3}------------------------------------------------ : : : : : · Page 4 : {4}------------------------------------------------ | Comparative Characteristic or Feature | Subject Device DiaSys ASAT (GOT) FS assay (K080485) | Predicate Device Roche/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/dL Lipemia: L index of 500 | | | | | | | | | | | | | | | | | | Interference < 10% by Level ASAT [U/L] Ascorbic acid up to 30 mg/dL 25.4 58.1 Conj. Bilirubin up to 60 mg/dL 22.3 55.8 Unconj. Bilirubin up to 24 mg/dL 22.4 54.1 Triglycerides up to 400 mg/dL 23.3 78.2 | | | | | | | | | | | | | | | | | | | With P-5-P | | | | | | | | | | | | | | | | | | | Interference < 10% by Level ASAT [U/L] Ascorbic acid up to 30 mg/dL 35.3 67.8 Conj. Bilirubin up to 36 mg/dL 31.2 66.9 Unconj. Bilirubin up to 24 mg/dL 31.5 65.9 Triglycerides up to 400 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 | | | | | | | | | | | | | | | | | - : : : : . . . : | Comparative Characteristic or Feature | Subject Device DiaSys TruCal U calibrator (K080485) | Predicate Device Roche Calibrator for automated systems (K990460) | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications For 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. | The Calibrator for automated systems (C.f.a.s.) is for use in the calibration of the quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. | | Matrix | Lyophilized human serum | Lyophilized human serum | | Levels | Single level | same | | Stability | Unopened: 17 months at 2-8°C Opened: 2 days at 2-8°C 8 hours at 25 °C 4 weeks at -20 °C (frozen only once) | Unopened: Stable at 2-8°C until expiration date Opened: 2 days at 2-8 °C | | Traceability | ASAT target values in TruCal U are traceable to the International Federation of Clinical Chemistry (IFCC) | Traceability of the target values is given in the respective instructions for use of the system reagents. | : : : {5}------------------------------------------------ | Comparative Characteristic or Feature | Subject Device DiaSys TruLab N and TruLab P controls (K080485) | Predicate Device Roche Precinorm U and Precipath U controls (K042389) | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications For 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. | Precinorm U Plus / Precipath U Plus are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet | | Matrix | Lyophilized human serum | same | | Stability | Unopened: 36 months at 2-8°C Opened: 2 days at 2-8°C 8 hours at 25 °C 4 weeks at -20 °C (frozen only once) | Unopened: Until expiration date at 2-8°C. Opened: 12 hours at 15-25°C 5 days at 2-8°C 4 weeks at -15 to -25°C when frozen once | ﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ . . : . 스 : {6}------------------------------------------------ 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). {7}------------------------------------------------ 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 {8}------------------------------------------------ ## 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

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

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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