MACRA LP(A) ENZYME IMMUNOASSAY KIT

• K Number: K992665
• Device Name: MACRA LP(A) ENZYME IMMUNOASSAY KIT
• Manufacturer: TRINITY BIOTECH USA
• Date Cleared: 1999-11-26 ( 109 days)
• Product Code: DFC
• Regulation Number: 866.5600
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: K013130

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 (CHD) in specific populations, along with other risk factors.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Macra® Lp(a) Enzyme Immunoassay Kit." This document does not contain the acceptance criteria or a study detailing device performance. It is a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. The information typically found in such a study would include:

1. A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, linearity, detection limits, etc., and compare them against predetermined thresholds.
2. Sample size used for the test set and the data provenance: Information on the number of samples used for validation and where these samples originated (e.g., patient cohorts, geographical locations, retrospective or prospective collection).
3. Number of experts and their qualifications: Not applicable for an immunoassay. This is relevant for devices involving human interpretation of results (e.g., imaging devices).
4. Adjudication method: Not applicable for an immunoassay. This is relevant for devices involving human interpretation of results.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable for an immunoassay, as the device provides quantitative measurements. This is relevant for devices that assist human readers in making diagnoses or interpretations (e.g., CAD systems for radiology).
6. Standalone performance: This document implicitly refers to the standalone performance of the assay itself, but provides no data. For an immunoassay, "standalone" means the performance of the kit in measuring the analyte.
7. Type of ground truth used: For an immunoassay, the ground truth for performance evaluation usually involves reference methods (e.g., mass spectrometry, established gold-standard assays) for quantitative comparisons, or clinical outcomes for risk assessment validation. This document does not specify.
8. Sample size for the training set: Not applicable for a traditional immunoassay, which does not typically involve machine learning training in the same way an AI-powered device would. Its "training" is more akin to assay optimization and calibration.
9. How the ground truth for the training set was established: Not applicable for a traditional immunoassay in the context of machine learning.

The document states the device's "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 (CHD) in specific populations, along with other risk factors. This indicates the intended purpose, but not the performance metrics or study details.

To obtain the requested information, one would typically need to consult the full 510(k) submission, including the performance studies submitted to the FDA, or related peer-reviewed publications.

Summary

{0}------------------------------------------------

Image /page/0/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 features three lines forming a shape reminiscent of a bird or a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 1999

Mr. Wayne A. Kvetkosky Manager, Regulatory Affairs Trinity Biotech (USA) P.O. Box 1059 Jamestown, New York 14702

Re: K992665

Trade Name: Macra® Lp(a) Enzyme Immunoassay Kit Regulatory Class: II Product Code: DFC Dated: October 28, 1999 Received: November 1, 1999

Dear Mr. Kvetkosky:

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 Ouality System Regulation (OS) 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.

{1}------------------------------------------------

Page 2

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/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

{2}------------------------------------------------

K992665 510(k) Number: Not Known

Device Name: Macra ® Lp (a) Enzyme Linked Immunosorbant Assay (ELISA) Automated Application

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 (CHD) 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)

Regulation Number and Section

§ 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).