(400 days)
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No
The summary describes a qualitative ELISA assay, which is a standard laboratory technique and does not mention any AI or ML components.
No.
The device is described as a qualitative plate ELISA for the detection of human anti-rabbit antibodies, which is a diagnostic purpose, not a therapeutic one. It identifies a biological marker associated with therapeutic interventions, but does not itself provide therapy.
Yes
The device is described as a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum, with the presence of these antibodies being associated with patients receiving therapeutic rabbit antibodies. This indicates its use in identifying a clinical condition or state, which is the definition of a diagnostic device.
No
The device is described as a "qualitative plate ELISA," which is a laboratory assay involving physical reagents and equipment, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that ThymoStat™ is for the "detection of human anti-rabbit antibodies in human serum." This involves testing a biological sample (human serum) in vitro (outside the body) to obtain information about a patient's health status (presence of antibodies).
- ELISA: The device is described as a "qualitative plate ELISA." ELISA (Enzyme-Linked Immunosorbent Assay) is a common laboratory technique used for in vitro diagnostic testing.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. The ThymoStat™ fits this description.
N/A
Intended Use / Indications for Use
ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum.
The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.
Product codes
DAK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
SEP 3 0 1998
Hana B. Moran, Ph.D. Senior Vice President Regulatory Affairs and Quality Assurance Sangstat Medical Corporation 1505 Adams Drive Menlo Park, California 94025
Re : K973203/S2
Trade Name: ThymoStat™ ELISA for the Detection of Human IgG, M and A anti-Rabbit IgG Antibodies Regulatory Class: II Product Code: DAK Dated: August 31, 1998 Received: September 1, 1998
Dear Dr. Moran:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 leqally 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 labelinq 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 (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/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
| 510(k) Number (if known): | #K973203 |
|---|---|
| Device Name: | ThymoStat™ ELISA for Detection of Human anti-Rabbit Antibodies |
| Indications for Use: | ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. |
The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit |
antibodies for therapeutic purposes.
(Please Do Not Write Below This Line - Continue On Another Page If Needed Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maples
Division Sign-Off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973203
Prescription Use
(Per 21 CFR §801.109)
Or
Over-The-Counter Use (Optional Format 1-2-96)