(75 days)
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No
The summary describes an in-vitro diagnostic test kit for measuring catecholamines and does not mention any AI or ML components.
No
This device is an in-vitro diagnostic test kit used to measure catecholamines in human plasma and urine, aiding in the diagnosis and follow-up of specific conditions. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the test kits are "useful as an aid in the diagnosis" of various conditions.
No
The device is an in-vitro diagnostic test kit, which involves physical reagents and laboratory procedures, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states "The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination..." This directly identifies the device as an in vitro diagnostic.
- Sample Type: The test is performed on "human plasma and urine," which are biological samples analyzed outside of the living body.
- Purpose: The test is used as "an aid in the diagnosis as well as the follow-up of... pheochromocytoma, but also the neuroblastoma and the ganglioneuroma." This indicates a medical purpose for diagnosing or monitoring a disease or condition.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine.
The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.
Product codes
CHQ
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1165 Catecholamines (total) test system.
(a)
Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IBL- Hamburg GmbH c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd. East Stroudsburg, PA 18301
Re: K051969
Trade/Device Name: TriCat RIA (Adrenaline/Dopamine/Dopamine), KatCombi RIA (Adrenaline/Noradrenaline). Adrenaline RIA and Noradrenaline RIA Regulation Number: 21 CFR 862.1165 Regulation Name: Catecholamines (total) test system Regulatory Class: Class I Product Code: CHQ Dated: July 5, 2005 Received: July 20, 2005
Dear Mr. Lehnus:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):_K051969
Device Name: TriCat RIA (Adrenaline/Noradrenaline/Dopamine) KatCombi RIA (Adrenaline/Noradrenaline) Adrenaline RIA Noradrenaline RIA
Indications For Use:
The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine.
The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
C.C.W.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sale
:10(k) /2051969
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