(42 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 or ML components.
No
The device is a calibrator set used to establish points of reference for the quantitative determination of C-reactive protein, which is a diagnostic purpose, not a therapeutic one.
No
The device is a calibrator set, used to establish reference points for the quantitative determination of C-reactive protein (CRP), not to directly diagnose a condition.
No
The device is a calibrator set, which is a physical component used in a laboratory test. The description clearly indicates it is used with a "Kit" for "immunoturbidimetric measurement," implying a hardware-based assay. There is no mention of software as the primary or sole component.
Yes, based on the provided information, 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 C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement." This involves testing biological samples (serum or plasma) outside of the body to provide information about a person's health status (CRP levels).
- Medical Purposes: The intended use also states it's for "medical purposes." This aligns with the definition of an IVD, which is used to diagnose, monitor, or treat medical conditions.
- Use with an IVD Kit: It is intended for use with the "RDI hs CRP Kit," which is itself an IVD kit for measuring CRP. Calibrators are essential components of many IVD tests.
Therefore, the RDI hs CRP Calibrator Set fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) 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
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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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered on the page. The text is likely the header of a document or website for the Department of Health and Human Services. The image is simple and straightforward, with a focus on the text.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 7 2002
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford, MA 01730
Re: K021607
Trade/Device Name: RDI hs CRP(C-reactive protein) Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: May 15, 2002 Received: May 16, 2002
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 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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REFERENCE DIAGNOSTICS, INC.
Abbreviated 510(k): RDI hs CRP Calibrator Set
19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730 Tel 781 276-9000 Fax 781 276-9002
Statement of Intended Use
Page 1 of 1
510(k) Number (if known): K021607
RDI hs CRP (C-reactive protein) Calibrator Set Device Name:
Indications For Use:
The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.
Summary and Explanation of the Test:
Measurement of CRP helps in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases. The accuracy of the CRP measurements is insured by using calibrators that are traceable to the international reference preparation (CRM470).
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
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