(286 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay based on enzymatic reactions and spectrophotometric measurement, with no mention of AI or ML components.
No
This device is an in vitro diagnostic assay used for measuring enzyme activity for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "quantitative in vitro diagnostic determination" and that "Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease." This directly indicates its role in diagnosis.
No
The device description clearly outlines a chemical assay (reagents) and calibrators/controls for use on a specific hardware instrument (Hitachi 917). This is an in vitro diagnostic (IVD) test kit, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the 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." It also mentions that the measurement "aids in the diagnosis and treatment of certain types of liver and heart disease." The phrase "For in vitro diagnostic use" is repeated multiple times.
- Device Description: The description details the biochemical reaction used to measure the enzyme activity in a sample (human serum and plasma).
- Performance Studies: The document includes performance data such as method comparison and precision, which are typical for IVD devices.
- Predicate Device(s): The inclusion of predicate devices with K numbers (which are FDA clearance numbers for medical devices, including IVDs) further confirms its classification as an IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
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. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.
Product codes (comma separated list FDA assigned to the subject device)
CIT, JIT, JJX
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' 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%
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.
Interferences:
Without P-5-P (Interference
§ 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.
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 L-Glutamate + Oxalacetate
Oxalacetate + NADH + H' 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
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
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