(51 days)
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No
The summary describes liquid quality control materials and calibration verifiers for laboratory instruments. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is described as an assayed quality control material and calibration verifiers for evaluating the performance of bilirubin testing systems, not for treating patients.
No
The device is described as quality control material and calibration verifiers, not for diagnosing patient conditions directly.
No
The device description explicitly states that the products are "assayed, liquid, quality control products," indicating they are physical substances, not software.
Based on the provided text, the devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states they are "quality control material" and "calibration verifiers" for evaluating the performance of systems used to measure Total and Direct Bilirubin. Bilirubin measurement is a common in vitro diagnostic test performed on biological samples (like blood).
- Device Description: The description reinforces their use as "assayed quality control products" for evaluating the performance of diagnostic systems.
- Nature of the Product: Quality control materials and calibration verifiers are essential components used in vitro (outside the body) to ensure the accuracy and reliability of diagnostic tests performed on patient samples.
Therefore, these devices fit the definition of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.
CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A – E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations.
Product codes
JJX
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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§ 862.1660 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three thick, curved lines that form the shape of the bird's body and wings. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 8 2005
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, CA 92028
K052679 Re:
Trade/Device Name: CLNIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A-E for Olympus AU Systems™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 26, 2005 Received: September 28, 2005
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. Ilsting 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 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 nother the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Art from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Alberto G.
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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510(k) Number (if known): Ko 52679
Device Name: CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3
Indications For Use:
CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.
Device Name: CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems™ .
Indications For Use:
CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A – E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations.
Prescription Use X
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tracy Phillips
Division Sign-Off
510(k)_K052679