(92 days)
No
The summary describes a standard immunoassay and analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic assay used for quantitative measurement of homocysteine to assist in diagnosis and treatment; it does not directly treat a condition.
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 described as a Fluorescence Polarization Immunoassay (FPIA) for use on the IMx Analyzer, indicating it is a laboratory assay kit with associated hardware (the analyzer), not a standalone software product.
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).
- Device Description: The description confirms it's a "Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma". This further reinforces the in vitro nature of the test.
- Assists in Diagnosis and Treatment: The intended use also states it "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria". This is a key characteristic of IVDs, which provide information used for medical purposes.
The information provided clearly indicates that this device is designed to perform tests on biological samples in vitro to provide information for diagnostic and treatment purposes, which is 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 Lhomocysteine 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
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.
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 method. 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, vielded 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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§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
510(k) Summary 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. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Hyperhomocysteinemia, elevated levels of homocysteine, can be associated with an increased risk of cardiovascular disease.
There are several 510(k) cleared methods for measurement of amino acids. 1,33 All these methods are based on HPLC separation and either traditional post-column derivitization (LKB. Beckman) or pre-column derivitization (Waters). Homocysteine can be analyzed using a traditional HPLC method with post-column derivitization. For example, Poele-Pothoff 4 et al. used a traditional system with 3 hours analysis for this purpose (LKB 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 method. 7 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. 8
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 or plasma (lithium heparin or tripotassium EDTA). A correlation analysis between these two assays, using 114 specimens, vielded a correlation coefficient of 0.989, slope of 0.980, and y-intercept of 0.12 umol/L.
1
Both the IMx Homocysteine assay and HPLC total homocysteine assays have been used to assess the connection between hyperhomocysteinemia and cardiovascular risk. Two recent prospective studies using either the IMx Homocysteine assay or HPLC total homocysteine method demonstrated the association between hyperhomocysteinemia and risk for cardiovascular disease349. The results of the study using IMx Homocysteine conducted by Dr. Ridker demonstrated that post-menopausal women with elevated homocysteine levels (highest quartile) had a two-fold increase risk of any cardiovascular event. In addition, the Framingham Heart Study also demonstrated that elevated levels of homocysteine in elderly men and women are independently associated with increased rates of all-cause and cardiovascular disease mortality.10
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. The revised labeling in the Summary and Explanation of the Test (package insert) reflects the relationship between hyperhomocysteinemia and risk of cardiovascular disease.
Prepared and submitted by:
Ronald Reagan
Date: September 10, 1999
Ronald G. Leonardi, Ph.D. President R&R Registrations P.O. Box 262069 San Diego, CA 92196 Phone (619) 586-0751
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- 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 2. Analyzer. 510(k) Number: K92093, 11/16/92.
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- Waters Chromatography Division. Waters Pico Tag Chem Pack. Free Amino Acid Analysis Kit. 510(k) Number: K943978, 05/02/95.
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- Poele-Pothoff et al. Ann Clin Biocehm. 1995;32:218-220.
- ഗ് Andersson et al. Scand J Clin Lab Invest. 1989;49:445-449.
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- Candito et al. J of Chromatography. 1997'692:213-216.
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- Fiskerstrand et al. Clin Chem/ 19931:39:263-271.
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- Refsum et al. Clin Chem. 1989;35:1921-7.
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- Ridker et al. JAMA 1999;281:1871-21.
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- Bostom et al. Arch Intern Med. 1999:159:1077-80.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a clear and recognizable emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 1999 OCT
Axis Biochemicals, ASA c/o Ronald G. Leonardi, Ph.D. R & R Registrations P.O. Box 262069 San Diego, California 92196-2069
Re: K992274
Trade Name: IMx® System Homocysteine Regulatory Class: II Product Code: LPS Dated: September 10, 1999 Received: September 13, 1999
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 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 Sutman
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
4
Indication for Use Statement
510(k) Number: K992274
Device Name: IMx® SYSTEM HOMOCY STEINE
Indications for use:
The IMx® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total Lhomocysteine 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.
Sam Cooper
(Division Sign-Off)
Division of Clinical Laboratory vicut
510(k) Numbe: K792274
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)