K Number
K991720
Device Name
KRONUS OPTIQUANT THYROGLOBULIN KIT
Manufacturer
Date Cleared
1999-08-09

(81 days)

Product Code
Regulation Number
866.6010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a quantitative determination of a biomarker, which is typically performed using standard laboratory techniques.

No
The device is used for the quantitative determination of thyroglobulin, which aids in the detection of thyroid tissue. This is a diagnostic function, not a therapeutic one. It provides information for diagnosis rather than directly treating a condition.

Yes
The device is described as aiding in the "detection of local and metastatic thyroid tissue," which is a diagnostic purpose.

No

The provided text only describes the intended use of a device for measuring thyroglobulin in human serum. It does not contain any information about the device's description, technology, or components, making it impossible to determine if it is software-only.

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for the "quantitative determination of thyroglobulin (Tg) in human serum." This involves testing a biological sample (serum) in vitro (outside the body) to obtain diagnostic information.

The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The described intended use perfectly aligns with this definition.

N/A

Intended Use / Indications for Use

The KRONUS OPTIQUANT THYROGLOBULIN KIT is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.

Product codes

MSW

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - VISA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - VISA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 1999

A.P. Doerschuk, Ph.D. Manager of Regulatory Affairs Kronus Market Development Associates 1000 Calle Amanecer San Clemente, California 92673

K991720 Re:

Trade Name: Kronus Optiquant Thyroglobulin Kit Regulatory Class: II Product Code: MSW Dated: July 19, 1999 Received: July 20, 1999

Dear Dr. Doerschuk:

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 (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.

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 (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

2

  • D. INDICATIONS FOR USE STATEMENT

510(k) Number: _K999720

Device Name: KRONUS OPTIQUANT THYROGLOBULIN KIT

The KRONUS OPTIQUANT THYROGLOBULIN KIT Indications For Use: is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stur E. Maperm
(Division Sign-Off)

Division of Clinical Laboratory Devic 510(k) Nurnber

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)