MACRALP(A) ENZYME IMMUNOASSAY KIT

• K Number: K971157
• Device Name: MACRALP(A) ENZYME IMMUNOASSAY KIT
• Manufacturer: STRATEGIC DIAGNOSTICS, INC.
• Date Cleared: 1998-04-15 ( 383 days)
• Product Code: JHO , DFC
• Regulation Number: 862.1475
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

MACRA O LP (a) ENZYME The IN VITRO I mmuro solizant Assay (ELISA) kit is Fri CIAGNOSTIC the guartititive DEVICE FOR MIEASUILEMEN ASSESSment Ob SErum or plasma FOR CONCON ary heart 017EASE Risk OF F OLL )之:: SPECIFIC DORULLATIONS ALONG WITH Official FACTORS.

Device Description

IN VITRO I mmuro solizant Assay (ELISA) kit

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the MACRA Lp(a) Enzyme Immunoassay Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory clearance and not a detailed technical or clinical study report.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions, I would need a different type of document, such as:

• A summary of safety and effectiveness (SSE) from the 510(k) submission.
• A clinical study report.
• The device's instructions for use (IFU) or technical specifications.

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.