(93 days)
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No
The summary describes a calibrator set for a diagnostic kit, which is a chemical reagent, not a software-based device. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
This device is intended for use in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum, which is a diagnostic test, not a therapeutic treatment.
Yes
The device is a calibrator set used to establish reference points for the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum, which is a diagnostic measurement.
No
The 510(k) summary describes a "Calibrator Set" and a "Kit," which are physical components used in a laboratory test. There is no mention of software as the primary or sole component of the device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum." This involves testing a biological sample (human serum) outside of the body to obtain diagnostic information.
- Purpose: It's used "to establish points of reference that are used in the quantitative determination" with an IVD kit (RDI Direct TIBC Kit). This means it's a component or accessory specifically designed to be used with an IVD test.
The definition of an IVD generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems intended to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
This calibrator set fits this definition as it's a material used in vitro with an IVD kit to provide information about a physiological state (TIBC levels).
N/A
Intended Use / Indications for Use
The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.
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.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three overlapping human profiles, suggesting a sense of community and connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 2005
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive Suite 30 Bedford, MA 01730
Re: K052148
Trade/Device Name: Direct TIBC Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: October 25, 2005 Received: October 26, 2005
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. Iisting 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 Gutierrez, Ph.D.
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):
Device Name:
Direct TIBC Calibrator Set
Indications For Use:
The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.
Prescription Use (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 In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
STOKI
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