ABBOTT AXSYM HOMOCYSTEINE

K992858 · Abbott Laboratories · LPS · Oct 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992858
• Device Name: ABBOTT AXSYM HOMOCYSTEINE
• Applicant: Abbott Laboratories
• Product Code: LPS · Clinical Chemistry
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

The AxSYM® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the AxSYM System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Device Story

AxSYM Homocysteine is a fluorescence polarization immunoassay (FPIA) for quantitative measurement of total L-homocysteine in human serum or plasma. Device operates on the AxSYM System using antibodies specific for s-adenosyl-L-homocysteine. Used in clinical laboratory settings by trained personnel. Provides quantitative results to assist clinicians in diagnosing and treating patients with suspected hyperhomocysteinemia and homocystinuria.

Clinical Evidence

Bench testing only. Comparison study between AxSYM Homocysteine and IMx Homocysteine assays using 300 specimens. Least squares linear regression yielded r=0.985, slope 1.04 (95% CI 1.02-1.06), intercept -0.56 umol/L. Passing-Bablok regression yielded r=0.985, slope 1.08 (95% CI 1.05-1.10), intercept -0.80 umol/L.

Technological Characteristics

Fluorescence Polarization Immunoassay (FPIA). Automated competitive immunoassay. Uses antibodies specific for s-adenosyl-L-homocysteine. Designed for use on the AxSYM System.

Indications for Use

Indicated for the quantitative measurement of total L-homocysteine in human serum or plasma to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Regulatory Classification

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.

Predicate Devices

• Abbott IMx® Homocysteine assay

Submission Summary (Full Text)

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# ¥992858

## 510(k) Summary Abbott AxSYM® Homocysteine

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott AxSYM Homocysteine constitutes data supporting a substantially equivalent determination.

AxSYM Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative r ate volument of total L-homocysteine in human serum or plasma on the AxSYM System. AxSYM Homocysteine is calibrated with Abbott Homocysteine Calibrators. Abbott Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

Substantial equivalence has been demonstrated between the AxSYM Homocysteine assay and the Abbott IMx® Homocysteine assay. The intended use of both assays is for the quantitative measurement of total L-homocysteine. Both assays are automated, in vitro, competitive immunoassays that use antibodies specific for s-adenosyl-L-homocysteine. A least squares linear regression analysis between these two assays, using 300 specimens, yielded a correlation coefficient of 0.985, slope of 1.04 (95% confidence interval of 1.02 to 1.06), and y-axis intercept of -0.56 umoVL (95% confidence interval of -0.87 to -0.25). A Passing-Bablok linear regression analysis, using 300 specimens, yielded a correlation coefficient of 0.985, slope of 1.08 (95% confidence interval of 1.05 to 1.10), and y-axis intercept of -0.80 umol/L (95% confidence interval of -1.16 to -0.47).

AxSYM Homocysteine 510(k) August 1999 hcy 510k preface to section II lwp

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In conclusion, these data demonstrate that the AxSYM Homocysteine assay is as safe and effective as, and is substantially equivalent to, the IMx Homocysteine assay.

Prepared and Submitted August 24, 1999 by: Margaret Prochniak Regulatory Specialist ADD Regulatory Affairs 1-847-937-4106

Abbott Laboratories Department 9YC, Building AP31 200 Abbott Park Road Abbott Park, IL 60064-6200

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### OCT 2 5 1999

Ms. Margaret Prochniak Regulatory Specialist Abbott Laboratories ADD Regulatory Affairs Dept. 9YC, Bldg. AP 31 200 Abbott Park Road Abbott Park, Illinois 60064-6200

K992858 Re: Trade Name: Abbott AxSYM® Homocysteine Regulatory Class: II Product Code: LPS Dated: August 24, 1999 Received: August 25, 1999

Dear Ms. Prochniak:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notificantially equivalent (for the indications for use above and we nave delemined the ucvice is sedicate devices marketed in interstate commerce
s to devices to legally marketed in the links in the increasedments, or to devices stated in the enclosure) to legally marked processor wondments, or to devices that
prior to May 28, 1976, the enactment date of the Medical Device American Coad, Drug, and prior to May 26, 1970, the chactiven auto of the Federal Food, Drug, and have been reclassified in accordance with the pro the device, subject to the general controls Cosmetic Act (Act). Tou may, merciols, market include requirements for annual provisions of the Act. "The general oonlous provisions provises, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classifica (sec above) into sich additional controls. Existing major regulations (Premarket Approval), it may of subject to outer fielderal Regulations, Title 21, Parts 800 to 895. allecting your device can be found in the assumes compliance with the Current Good A substantially equirvalent determination assumts oche system Regulation (QS) for
Manufacturing Practice requirements, as set forth in the Quality System be and in one in the Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. Gelicial regulation (21 of A P P P P P P P P S will verify such assumptions. F ailure to inspections, the Pood and Drug Nammedation (1 = Laton . In addition, FDA may publish comply with the GMI Tegarator may reading in the Federal Register. Please note: this further alliouncements concorning your submission does not affect any obligation you might It spollse to your promanter as a see 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 [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and it you to organizatial equivalence of your device to a legally marketed notification. - The I Dr. In and ssification 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 [phone]. Additionally, for questions on the promotion and advertising of your device, (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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-frec number [phone] or [phone], 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

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510(k) Number (if known): K992858

Device Name: Abbott AxSYM® Homocysteine

Indications For Use:

The AxSYM® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the AxSYM System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Cooph

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992858

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Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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