(212 days)
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No
The description focuses on a standard immunoassay technique (FPIA) and its performance characteristics, with no mention of AI or ML terms or concepts.
No
The device is an assay for quantitative measurement, designed to assist in diagnosis, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria."
No
The device is a Fluorescence Polarization Immunoassay (FPIA) which is a laboratory assay requiring physical reagents and an analyzer (IMx Analyzer) to perform the measurement. This involves hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of total L-homocysteine in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Diagnosis and Treatment: The intended use also mentions assisting in the "diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria". This is a key characteristic of IVDs, which are used to provide information for diagnostic or treatment purposes.
- Device Description: The description confirms it's an "Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma". Immunoassays are a common type of IVD technology.
- Sample Type: The device analyzes "human serum or plasma", which are biological specimens.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMx Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Product codes
LPS, DFC
Device Description
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. IMx Homocysteine is calibrated with IMx Homocysteine Calibrators. IMx Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness of the IMx Homocysteine Assay, the IMx assay was compared to the University of Bergen Homocysteine HPLC mehtod. This method uses pre-column derivitization and permits rapid analysis. In the work of Poele-Pothoff, a similar precolumn method was compared to an amino acid analyzer method and was shown to give an excellent correlation. In addition, the Bergen HPLC method was shown to be equivalent to the amino acid analysis for detection of homocysteine.
A correlation analysis between these two assays, using 114 specimens, yielded a correlation coefficient of 0.989, slope of 0.980, and y-intercept of 0.12 umol/L.
Key Metrics
Correlation coefficient of 0.989, slope of 0.980, and y-intercept of 0.12 umol/L.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
KG80812
1 1998 OCT
510(k) Summarv IMx® Homocysteine Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for IMx Homocysteine constitutes data supporting a substantially equivalent determination.
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. IMx Homocysteine is calibrated with IMx Homocysteine Calibrators. IMx Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
There are several 510(k) cleared methods for measurement of amino acids. 1,2,3 All these methods are based on HPLC separation and either traditional post-column derivatization (LKB, Beckman) or pre-column derivatization (Waters). Homocysteine can be analyzed using a traditional HPLC method with post-column derivatization. For example, Poele-Pothoff et al. Used a traditional system with 3 hours analysis for this purpose (1.KB analyzer). Sera were reduced using dithiothreitol, then proteins were precipitated as would normally be done for this instrument. Candito et al. also published an analysis of homocysteine using a Beckman Amino Acid Analyzer, after reduction with dithiothreitol. Both of these methods are based on earlier work by Andersson , which used a modified separation on an amino acid analyzer.
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness of the IMx Homocysteine Assay, the IMx assay was compared to the University of Bergen Homocysteine HPLC mehtod. This method uses pre-column derivitization and permits rapid analysis. In the work of Poele-Pothoff, a similar precolumn method was compared to an amino acid analyzer method and was shown to give an excellent correlation. In addition, the Bergen HPLC method was shown to be equivalent to the amino acid analysis for detection of homocysteine.
LKB Instruments Inc. 4150 Alpha Amino Acid Analyzer. 510(k) Number: K820415, 02/11/82
- Beckman Instruments Inc. System 6300 Series High Performance Amino Acid Analyzer. 510(k) Number 2. K92093 11/16/92
- Poele-Pothoff et al. Ann Clin Biochem. 1995; 32:218-220.
- Andersson et al. Scand J Clin Lab Invest. 1989;49:445-449.
- Candito et al. J of Chromatography. 1997;692:213-216
- Fiskerstrand et al. Clin Chem. 1993; 39:263-271
- Refsum et al. Clin Chem. 1989;35:1921-7
Waters Chromatography Division. Waters Pico Tag Chem Pack. Free Amino Acid Analysis Kit. 510(k) Number: K943978, 05/02/95.
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Substantial equivalence has been demonstrated between the IMx Homocysteine assay and the Bergen HPLC method for measuring total homocysteine. The intended use of both assays is for the quantitative measurement of total homocysteine. Both the IMx Homocysteine assay and the HPLC total homocysteine assay can be performed with human serum of plasma (lithium heparin or tripotassium EDTA). A correlation analysis between these two assays, using 114 specimens, yielded a correlation coefficient of 0.989, slope of 0.980, and y-intercept of 0.12 umol/L.
In conclusion, these data demonstrate that the IMx Homocysteine assay is as safe and effective as, and is substantially equivalent to the HPLC total homocysteine assay.
Date
Prepared and submitted by:
Ronald C. Leonardi, Ph.D.
Ronald G/Leonardi, Ph. D. President R&R Registrations P.O. Box 262069 San Diego, CA 92196 Phone (619) 586-0751
Image /page/1/Picture/5 description: The image contains a solid black circle. The circle is centered in the image and takes up a significant portion of the frame. The background is white, providing a stark contrast to the black circle. There are some artifacts around the edges of the circle.
Image /page/1/Picture/6 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely featureless.
Image /page/1/Picture/7 description: The image shows a solid black circle against a white background. The circle is slightly off-center, positioned towards the right side of the frame. The black color of the circle contrasts sharply with the white background, creating a simple yet visually striking composition.
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Public Health Service
1 OCT
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ronald G. Leonardi, Ph.D. President R & R Reqistrations P.O. Box 262069 San Diego, California 92196-2069
Re: K980812 IMx® Homocysteine Regulatory Class: II Product Code: LPS, DFC Dated: September 10, 1998 Received: September 11, 1998
Dear Dr. Leonardi:
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, labelinq, 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 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 qeneral 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): K980812
Device Name: IMx Homocysteine
Indications for Use:
The IMx Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The- Counter Use _
(Optional Format 1-2-96)
:
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K980812