This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification document for a medical device. It is a regulatory approval, not a scientific study document. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document:

Identifies the device: Human alpha-2-Macroglobulin kit for use on SPAPLUS.
States its intended use: Quantitative in vitro measurement of alpha-2-Macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders.
Declares substantial equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes for test or training sets, nor data provenance.
Information on experts or ground truth for the test set.
Adjudication methods.
Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
Information on standalone algorithm performance.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. The information you're asking for would typically be found in a separate study report or technical documentation submitted as part of the 510(k) application, but it is not present in the FDA's decision letter itself.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall appearance is simple and straightforward, suggesting a formal or official context.

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 16, 2014

The Binding Site Group, Ltd c/o Mr. Jon Lauder Regulatory Affairs Specialist 8 Calthorpe Road Edgbaston, Birmingham B15 1QT United Kingdom

Re: K140664

Trade/Device Name: Human alpha-2-Macroglobulin kit for use on SPAPLUS Regulation Number: 21 CFR 866.5620 Regulation Name: Alpha-2-macroglobulin immunological test system Regulatory Class: II Product Code: DEB Dated: March 13, 2014 Received: March 18, 2014

Dear Mr. Lauder:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

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

Page 2-Mr. Jon Lauder

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K 140664

Device Name

Human alpha2-Macroglobulin Kit for use on SPAPLUS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

ላይ የሚገኝ የተደለቀዋል። የአማርኛ ምሳሌ ነው። ትርጉሙ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Maria M. Chan -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

14 17 געוואר 1 1 1 11 11 11 בארצייער 1 1 16 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 14 11 10 11 14 11 1 159

Regulation Number and Section

§ 866.5620

Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.