(117 days)
Not Found
No
The summary describes a standard in-vitro diagnostic test for enzyme activity and does not mention any AI/ML components or related concepts like image processing, training/test sets, or complex algorithms beyond basic statistical analysis.
No
The device is an in-vitro diagnostic system used for quantitative determination of an enzyme, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test system is intended 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 as a diagnostic device.
No
The device is described as an in-vitro diagnostic test system for use on a "T60 instrument," which implies a hardware component is involved in the measurement process. The summary also mentions "Auxiliary product: Pyridoxal Phosphate" and "Auxiliary reagent," further indicating a system that includes physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST)..."
This statement clearly indicates that the device is designed to be used outside of the body (in-vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
E. Indications 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CIT, JIX, JJY
Device Description
Not Found
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)
Method Comparison:
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
Precision:
1-reagent method:
Within run: Level 38 U/l, SD= 0.5, CV(%)= 1.4; Level 101 U/l, SD=0.9, CV(%)= 0.9; Level 189 U/l, SD= 1.0, CV(%)= 0.5
Among run: Level 101 U/l, SD=0.5, CV(%)= 0.5; Level 189 U/l, SD= 1.1, CV(%)= 0.6
Total: Level 38 U/l, SD= 0.9, CV(%)= 2.4; Level 101 U/l, SD= 2.0, CV(%)= 2.0; Level 189 U/l, SD= 3.2, CV(%)= 1.7
3-reagent method:
Within run: Level 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
Among 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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 2 | |
| P.O. Box 100 | ||
| FIN-01621 Vantaa | ||
| Finland | ||
| 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
I
JJY
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-lunnus 0921547-0
VAT No FI09215470 Domicile Helsinki
ww.thermo.com
1
| 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
2
E. Indications 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.
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
3
The following table compares the AST/ GOT (IFCC) with the predicate device. Table 1
| Table 1
| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| 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 | |
| IFCC | ||
| 3-reagent method: IFCC | ||
| Traceability/Standar | ||
| dization | 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: 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
9
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
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 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