(20 days)
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No
The 510(k) summary describes a quality control material for laboratory analysis and contains no mention of AI or ML technology.
No
This device is a quality control material for laboratory analysis, not a device used to provide therapy or treatment to patients.
No
The device is described as an "assayed quality control material" for tumor marker analysis, not a device that performs the analysis itself or provides a diagnosis. It is used to ensure the accuracy of other diagnostic devices.
No
The device description clearly indicates it is a "Liquid QC™ Tumor Marker Control," which is a physical substance used for quality control in laboratory analysis, not a software application.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "serum protein and tumor marker analysis." This involves testing biological samples (serum) outside of the body to obtain information about a patient's health status.
- Device Description: It is described as a "quality control material." Quality control materials are essential components used in IVD testing to ensure the accuracy and reliability of the test results.
The definition of an IVD generally includes reagents, calibrators, control materials, and other products intended for use in the in vitro examination of specimens derived from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes. This device clearly fits within this definition as a control material used in such examinations.
N/A
Intended Use / Indications for Use
CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis
Product codes
JJY
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
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Key Metrics
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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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head facing left, with three parallel lines extending from the back of the head, resembling feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle head.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, California 92028
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 6 2003
K030705 Re: Trade/Device Name: CLINIQA Liquid QC™ Tumor Marker Control Level 1 CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIOA Liquid OC™ Tumor Marker Control Level 3 CLINIQA Liquid QCTM Tumor Marker Control Level, Tri-Level Regulation Number: 21 CFR § 862.1660
Regulation Name: Multi Analyte Controls (Assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: March 5, 2003 Received: March 6, 2003
Dear Ms. Ruggiero:
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). 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.
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 030 7 05
CLINIQA Liquid QC™ Tumor Marker Control Level 1 Device Name: CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIQA Liquid QC™ Tumor Marker Control Level 3 CLINIQA Liquid QC™ Tumor Marker Control, Tri- Level
Indications For Use:
CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AP Reeves for S. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030705
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use