THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.

The Rubella IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum. The test is intended to be used to evaluate serologic evidence of primary or active infection with Rubella and is for in vitro diagnostic use.

Device Description

The Aptus (automated) Application of the Rubella IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum.

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the Rubella IgM ELISA." This letter grants clearance for the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.

The 510(k) letter states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a review of information submitted by the manufacturer to the FDA, which would have included performance data. However, the specific details of that performance data, the acceptance criteria used, and the study design are not present in the provided text.

Therefore, I cannot fulfill your request for the following information based solely on the provided document:

A table of acceptance criteria and the reported device performance: This information is not in the document.
Sample size used for the test set and the data provenance: Not in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not in the document.
Adjudication method for the test set: Not in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not in the document. This is also for an in vitro diagnostic device, not an AI-assisted diagnostic.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not in the document, and likely not applicable in the context of an ELISA assay.
The type of ground truth used: Not in the document. For an ELISA, this would typically involve reference methods or confirmed clinical status.
The sample size for the training set: Not in the document. The concept of a "training set" in the context of an ELISA assay is different from that of machine learning algorithms.
How the ground truth for the training set was established: Not in the document.

To obtain this information, you would need to access the full 510(k) submission (K984180) made to the FDA by Zeus Scientific, Inc., which is typically a much more detailed document than the clearance letter.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 20 1999

Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876

Re: K984180

Trade Name: The Aptus (automated) Application of the Rubella IgM ELISA

Regulatory Class: III Product Code: 83 LFX Dated: November 19, 1998 Received: November 23, 1998

Dear Mr. Kopnitsky:

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 Quality 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.

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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 (770)488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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): ____________________________________________________________________________________________________________________________________________________

Aptus (automated) Application for the Rubella IgM ELISA Device Name: Test System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

i i

(Per 21 CFR 801,109)

2-96)

Woody Dubois

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K984180

(Optional Format 1-

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.