(93 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a standard in vitro diagnostic assay.
No
The device is intended for in vitro diagnostic (IVD) use to determine the presence of mitochondrial antibodies in human serum, which is an aid in diagnosis, not a therapeutic intervention.
Yes
The device is intended for the in vitro determination of mitochondrial (M2) antibody in human serum, and these assays are explicitly stated to be used "as an aid in the diagnosis of Primary Biliary Cirrhosis". This direct contribution to diagnosis qualifies it as a diagnostic device.
No
The intended use describes an in vitro diagnostic device for determining mitochondrial antibodies in human serum, which inherently involves laboratory hardware and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states:
- "Intended for the in vitro determination of mitochondrial (M2) antibody in human serum." The phrase "in vitro determination" is a key indicator of an IVD.
- "Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090" This further clarifies that the device is used to analyze a sample (human serum) outside of the body for diagnostic purposes, which aligns with the definition of an IVD. The CFR reference also points to a specific regulation for IVDs.
N/A
Intended Use / Indications for Use
Intended for the in vitro determination of mitochondrial (M2) antibody in human serum.
Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090
Product codes
DBM
Device Description
TRACE Enzymatic Mitochondria (M2) Antibody reagent
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
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the title or heading of a document or webpage. The font is a serif typeface, and the text is black against a white background.
SEP 17 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Trace Scientific Ltd. David Johnston c/o Trace America Inc. 7260 North West 58th Street Miami, FL 33166
Re: K982121 Trade Name: TRACE Enzymatic Mitochondria (M2) Antibody Reagent Regulatory Class: II Product Code: DBM Dated: Auqust 19, 1998 Received: August 24, 1998
Dear Mr. Johnston: ·
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 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, Druq, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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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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 requlation (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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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8.0 INDICATIONS / USE
510(K) Number (if Known): K982121
Page 1 _ of _ of _ l_
Device Name : TRACE Enzymatic Mitochondria (M2) Antibody reagent Indications for use:
Intended for the in vitro determination of mitochondrial (M2) antibody in human serum.
Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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OR
Over - The - Counter-Use______________________________________________________________________________________________________________________________________________________
Peter E. Mancini