(177 days)
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No
The summary describes an immunoradiometric assay (IRMA) for measuring calcitonin levels, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is a diagnostic tool used to measure calcitonin levels for the diagnosis and treatment of diseases, not to provide therapy itself.
Yes
The intended use explicitly states that calcitonin measurements, which this device provides, are "used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands."
No
The device description explicitly states "Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)", which describes a laboratory assay kit involving physical components (coated tubes) and chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum." This involves testing a biological sample (serum) outside of the body.
- Purpose: The measurements are used "in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description "Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)" describes a laboratory test method performed on a biological sample.
Therefore, based on the provided information, the Scantibodies Laboratory Inc. Calcitonin test system fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
Product codes
JKR
Device Description
Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)
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
thyroid and parathyroid glands
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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§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol of medicine, with three intertwined snakes wrapped around a staff. The logo is encircled by the words "U.S. Department of Health & Human Services" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Nordstrom Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071
AUG 3 0 2006
Re: K060578 Trade/Device Name: Calcitonin Immunoradiometric Asay (IRMA) (Coated Tube Version) Regulation Number: 21 CFR 862.1140 Regulation Name: Calcitonin test system Regulatory Class: Class II Product Code: JKR Dated: August 10, 2006 Received: August 14, 2006
Dear Mr. Nordstrom:
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,
Alberto G
Alberto Gutierrez, Ph.D. 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): K060578
Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version) Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
Prescription Use XX (Part 21 CFR 801 Subpart D) C)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K060577
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