(28 days)
Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum on both automated and manual systems.
Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Sigma Diagnostics INFINITY AST Reagent is based on the recommendations of the IFCC. The series of reactions involved in the assay system is as follows:
- AST present in the sample catalyzes the transfer of the amino group from L-aspartate to 2-1 . oxoglutarate forming oxaloacetate and L-glutamate.
- Oxaloacetate in the presence of NADH and Malate dehydrogenase (MDH), is reduced to 2. L-malate. In this reaction NADH is oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
- Addition of Lactate dehydrogenase (LDH) to the reagent is necessary to achieve rapid and 3. complete reduction of endogenous pyruvate so that it does not interfere with the assay.
The provided text is a 510(k) summary and FDA clearance letter for an in vitro diagnostic reagent, the Sigma Diagnostics INFINITY™ AST Reagent. This type of device is a chemical reagent used in laboratory tests and does not involve AI or algorithms in the way typically discussed for medical imaging or other diagnostic tools.
Therefore, many of the requested bullet points, such as those related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truth methods for AI models, are not applicable to this type of device.
This document describes the intended use and substantial equivalence to a predicate device, rather than a study demonstrating meeting specific performance criteria in the context of an AI/ML device.
However, I can extract information relevant to the device's characteristics and the basis for its clearance:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state quantitative "acceptance criteria" for performance metrics in a table. Instead, it asserts substantial equivalence to a predicate device, meaning its performance is considered comparable and acceptable based on the predicate's established performance.
- Acceptance Criteria (Implied by Substantial Equivalence): The device's performance characteristics (e.g., accuracy, precision, linearity, analytical measurement range) are deemed equivalent to the legally marketed predicate device (TRACE Scientific AST (DST) Reagent Kit, K961114). The specific quantitative criteria met by the predicate are not detailed in this summary.
- Reported Device Performance: The document states, "The Sigma Diagnostics INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114." This statement is the reported performance, indicating that it performs identically to an already-cleared device. No independent performance data for the INFINITY™ AST Reagent is provided beyond this claim of equivalence.
2. Sample size used for the test set and the data provenance
Not applicable as this is a reagent and not an AI/ML device requiring a test set for performance evaluation in the context of an algorithm. The basis for clearance is substantial equivalence to an existing product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an IVD reagent, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a chemical reagent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For an IVD reagent, "ground truth" typically refers to the accuracy of its analytical measurement against a reference method or known concentration standards, but these details are not provided in this summary. The substantial equivalence claim suggests that the analytical performance matches the predicate.
8. The sample size for the training set
Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model to train.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFINITY™ AST Reagent, Procedure 51-UV
Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum on both automated and manual systems.
AST is widely distributed with high concentrations in the heart, liver, skeletal muscle, kidney and erythrocytes. Damage or disease to any of these tissues such as myocardial infarction, viral hepatitis, liver necrosis, cirrhosis and muscular dystrophy may result in raised serum levels of AST.
The Sigma Diagnostics INFINITY AST Reagent is based on the recommendations of the IFCC.2 The series of reactions involved in the assay system is as follows:
- AST present in the sample catalyzes the transfer of the amino group from L-aspartate to 2-1 . oxoglutarate forming oxaloacetate and L-glutamate.
- Oxaloacetate in the presence of NADH and Malate dehydrogenase (MDH), is reduced to 2. L-malate. In this reaction NADH is oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
- Addition of Lactate dehydrogenase (LDH) to the reagent is necessary to achieve rapid and 3. complete reduction of endogenous pyruvate so that it does not interfere with the assay.
The Sigma Diagnostics INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114.
References
- Zilva JF, Pannall PR. "Plasma Enzymes in Diagnosis" in Clinical Chemistry in Diagnosis 1. and Treatment. Lloyd-Luke London. 1979:Chap 17:338-9.
- IFCC Method for L-Aspartate aminotransferase. J Clin Chem Clin Biochem 1986; 2. 24:497-510.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 20 1998
William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
Re : K980666 INFINITY™ AST Reagent (Procedure No. 51) Regulatory Class: II Product Code: CIT Dated: February 19, 1998 Received: February 20, 1998
Dear Dr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with - the Current Good Manufacturing Practice requirements, as set ---forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____K980666
Device Name: Sigma Diagnostics INFINITY™ AST Reagent
Indications For Use:
Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off).
Division of Clinical Laboratory Devices
510(k) Number. K980666
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _
§ 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.