(108 days)
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No
The summary describes a calibrator set for an immunoturbidimetric assay, which is a standard laboratory technique and does not mention any AI/ML components.
No
The device is a calibrator set used to establish reference points for quantitative determination of Ferritin, not to treat or diagnose a disease directly.
No
The device is a calibrator set used to establish points of reference for the quantitative determination of Ferritin, not to diagnose a condition itself.
No
The device is a calibrator set, which is a physical component used in a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement." This involves testing biological samples (serum or plasma) outside of the body (in vitro) to diagnose or monitor a medical condition (related to ferritin levels).
- Medical Purposes: The intended use also states it's for "medical purposes," which is a key characteristic of IVDs.
- Use with an IVD Kit: It's intended for use with the "RDI Ferritin Kit," which is itself an IVD kit for measuring ferritin. Calibrators are essential components of many IVD assays.
Therefore, based on the provided information, the RDI Ferritin Calibrator Set clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
Product codes
JIT
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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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administrat 2098 Gaither Road Rockville MD 20850
MAR 1 3 2006
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford MA, 01730
Re: K053291 Trade/Device Name: RDI Ferritin Calibrator Set Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 23, 2006 Received: February 24, 2006
Dear Dr. Lawlor:
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. A.
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
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Indications for Use
510(k) Number (if known): K053291
Device Name:
RDI Ferritin Calibrator Set
Indications For Usc:
The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
Prescription Use (Per 21 CFR 801.109)
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 (ODE)
CA
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
10(k) KOS3291