(112 days)
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No
The summary describes a traditional RIA assay kit for detecting antibodies, with no mention of AI, ML, image processing, or any computational analysis beyond standard assay interpretation.
No
The device is an assay kit used for diagnosis and not for treatment or therapy.
Yes
The device is used as "an aid in the diagnosis of myasthenia gravis (MG)," which directly indicates its role in diagnostics.
No
The device is described as an "Assay Kit" for determining antibodies in human serum, which strongly suggests it is a laboratory test kit involving physical reagents and procedures, not a software-only device.
Yes, based on the provided information, the KRONUS Blocking AChRAb RIA Assay Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum." This involves testing a biological sample (human serum) outside of the body.
- Purpose: It is described as "useful as an aid in the diagnosis of myasthenia gravis (MG)." This indicates its use in a clinical setting for diagnostic purposes.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).
Product codes
NST
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or figures, creating an abstract representation of people.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
KRONUS Market Development Associates, Inc. c/o Ms. Heather Viele Director, Technical Affairs 12554 West Bridger St. Suitc 108 Boise, ID 83713
JUN 1 7 2008
Re: K080523
Trade/Device Name: KRONUS I123 Acetylcholine Receptor Blocking Antibody Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NST Dated: May 19, 2008 Received: May 28, 2008
Dear Ms Viele:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K080523 510(k) Number (if known): To be ussigned by FDA
Device Name:
KRONUS Blocking Acetylcholine Receptor Autoantibody (AChRAb) RIA Assay Kit
Indications for Use Statement:
The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).
(Please Do Not Write Below This Line - Continue On another Page If Needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Pursuant to 21 CFR 801.109)
Over-the-counter Use__________________________________________________________________________________________________________________________________________________________
Mare M chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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