MACRALP(A) ENZYME IMMUNOASSAY KIT

K971157 · Strategic Diagnostics, Inc. · JHO · Apr 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K971157
• Device Name: MACRALP(A) ENZYME IMMUNOASSAY KIT
• Applicant: Strategic Diagnostics, Inc.
• Product Code: JHO · Clinical Chemistry
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Macra® Lp(a) Enzyme Linked Immunosorbant Assay (ELISA) kit is an in vitro diagnostic device for the quantitative measurement of Lp(a), in human serum or plasma, for the assessment of risk for coronary heart disease in specific populations, along with other risk factors.

Device Story

Macra® Lp(a) is an enzyme-linked immunosorbent assay (ELISA) kit; used for in vitro diagnostic quantitative measurement of lipoprotein(a) [Lp(a)] in human serum or plasma. Device operates in clinical laboratory settings; performed by trained laboratory personnel. Input is patient serum or plasma sample; assay utilizes immunological binding principles to quantify Lp(a) concentration. Output is numerical concentration value; used by clinicians to assess coronary heart disease risk alongside other clinical risk factors. Provides objective data to support cardiovascular risk stratification.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) kit; in vitro diagnostic; quantitative measurement; manual or semi-automated laboratory procedure.

Indications for Use

Indicated for quantitative measurement of Lp(a) in human serum or plasma to assess coronary heart disease risk in specific populations, used in conjunction with other risk factors.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

APR 15 1998

Donald W. Durandetta, Ph.D.
Marketing Manager
Strategic Diagnostics Inc.
128 Sandy Drive
Newark, Delaware 19713-1147

Re: K971157
Macra®Lp(a) Enzyme Immunoassay Kit
Regulatory Class: I & II
Product Code: JHO, DFC
Dated: January 15, 1998
Received: January 16, 1998

Dear Mr. Durandetta:

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, 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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Apr-15-98 09:50 Lion Square Lodge
970 476 7423
10:13024300776
PAGE 1 of 1

510(k) Number (if known): K971157
Device Name: MACRA Lp(a)

Indications For Use:

The Macra® Lp(a) Enzyme Linked Immunosorbant Assay (ELISA) kit is an in vitro diagnostic device for the quantitative measurement of Lp(a), in human serum or plasma, for the assessment of risk for coronary heart disease in specific populations, along with other risk factors.

(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)

Patricia A. Berlawt (for A. Montgomery)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 971157