(212 days)
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.
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.
Here's an analysis of the provided information about the IMx® Homocysteine device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (Bergen HPLC method) | Correlation Coefficient: 0.989 |
| Slope of Regression (IMx vs. Bergen HPLC) | Slope: 0.980 |
| Y-intercept of Regression (IMx vs. Bergen HPLC) | Y-intercept: 0.12 umol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 114 specimens
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, it compares the IMx Homocysteine assay to an existing, validated analytical method (the University of Bergen Homocysteine HPLC method), which serves as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. The study compares a new analytical method to an established reference method, rather than involving human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic device (IVD) based on a quantitative immunoassay, not an imaging device or a device that involves human interpretation of results in a diagnostic setting in the typical sense of an MRMC study.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was performed. The IMx Homocysteine assay's performance was evaluated by directly comparing its quantitative measurements against the Bergen HPLC method on human serum or plasma specimens.
7. Type of Ground Truth Used
The ground truth used was the quantitative measurement of total L-homocysteine obtained from a reference analytical method: the University of Bergen Homocysteine HPLC method. This method was already established and shown to be equivalent to amino acid analysis for homocysteine detection.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. This is typical for an immunoassay where the "training" (calibration) is usually managed through a set of calibrators provided with the assay itself, rather than a separate large-scale data training process as seen in machine learning algorithms. The 114 specimens were used for the comparative evaluation study.
9. How the Ground Truth for the Training Set Was Established
As noted in section 8, the concept of a "training set" for ground truth establishment, in the sense of AI/ML, is not directly applicable here. The IMx Homocysteine assay is calibrated using "IMx Homocysteine Calibrators," and its accuracy and precision are verified using "IMx Homocysteine Controls." The ground truth for these calibrators and controls would have been established through robust analytical validation processes, likely against highly accurate reference methods, but the specifics are not detailed in this summary.
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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
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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
§ 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).