(40 days)
No
The device description details a chemical reaction-based assay for measuring AST levels, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic reagent used to quantitatively determine AST in human serum and plasma. It is not used to treat, mitigate, or cure a disease or condition, which is the definition of a therapeutic device.
Yes
The "Intended Use / Indications for Use" states that the device is for "in vitro quantitative determination of AST...in human serum and plasma," which is a measurement used for diagnostic purposes.
No
The device is a reagent kit used for in vitro diagnostic testing, involving chemical reactions and measurement of absorbance, which are hardware-dependent processes. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the in vitro quantitative determination of AST... in human serum and plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a chemical reaction that occurs outside the human body to measure a substance (AST) in a biological sample (serum and plasma).
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K961114) indicates that this device is being compared to a previously cleared medical device, which is a common process for IVDs seeking regulatory approval.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum and plasma on both automated and manual systems.
Product codes
CIT
Device Description
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 1. 2-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.
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)
Correlation studies to Sigma Diagnostics AST Reagent, Procedure No. 58 (K954839) using plasma samples yielded a regression equation of: INFINITY AST = 0.98 (AST 58) + 0.6 (N=126)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 8 1999
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 and plasma 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 1. 2-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.
Correlation studies to Sigma Diagnostics AST Reagent, Procedure No. 58 (K954839) using plasma samples yielded a regression equation of:
INFINITY AST = 0.98 (AST 58) + 0.6 (N=126)
References
-
- Zilva JF, Pannall PR. "Plasma Enzymes in Diagnosis" in Clinical Chemistry in Diagnosis and Treatment. Lloyd-Luke London. 1979:Chap 17:338-9.
-
- IFCC Method for L-Aspartate aminotransferase. J Clin Chem Clin Biochem 1986; 24:497-510.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 8 1999
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics® Clinical Technical Services 545 South Ewing Avenue St. Louis, Missouri 63103
Re: K992801
Trade Name: Infinity™ AST Reagent (Procedure No. 51) Regulatory Class: II Product Code: CIT Dated: August 16, 1999 Received: August 19, 1999
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 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). 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 regulatory action. In addition, FDA may publish further announcements 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 regulations.
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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 your 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sigma Diagnostics INFINITY™ AST Reagent
Indications For Use:
Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum and plasma on both automated and manual systems.
Sean Cooper
(Division Sign-Off) Division of Clinical Laborate L vices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OH
Over-The-Counter Use _