(16 days)
Not Found
Not Found
No
The summary describes a quality control material for an immunoassay, with no mention of AI or ML technologies.
No
The device is described as a quality control material for monitoring the performance of assays, not for treating a condition.
No
The device is described as a quality control material for monitoring the performance of assays, not for diagnosing medical conditions in patients.
No
The device is described as a "Control Set" and "quality control material," which are physical substances used to verify the performance of assays. There is no mention of software as the primary component or function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the performance of C-Reactive Protein immunoturbidimetric assays." This means it's used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic test.
- Quality Control Material: It's described as an "assayed quality control material." Quality control materials are a fundamental component of IVD testing, used to ensure the test is working correctly.
While the other sections are "Not Found," the intended use alone is sufficient to classify this device as an IVD. It's a product used in a laboratory setting to evaluate the performance of another diagnostic test.
N/A
Intended Use / Indications for Use
The K-ASSAY® hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.
Product codes
DCK
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads facing to the right. The eagle is made up of three curved lines that represent the heads, wings, and tail feathers.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 4 2002
Mr. Brian Schliesman Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K022486 Trade/Device Name: K-ASSAY® hs-CRP Controls Regulation Number: 21 CFR § 866.5270 Regulation Name: C-Reactive Protein, Immunological Test System Regulatory Class: II Product Code: DCK Dated: July 22, 2002 Received: July 29, 2002
Dear Mr. Schliesman:
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 (QS) 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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INDICATIONS FOR USE STATEMENT
K022486 510(k) Number (if known):
K-ASSAY® hs-CRP Controls Device Name:
Indications For Use:
The K-ASSAY® hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sebastian Altaie
(Division Sign-Off) Division of Clinical Laboratory 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96)