(64 days)
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No
The summary describes calibration verifiers for laboratory analyzers, which are chemical reagents, not software or hardware that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques indicative of AI/ML.
No
The device is described as calibration verifiers intended for use in a clinical laboratory to verify calibration and assess linearity of analyzers, not to directly treat a medical condition.
No
Explanation: This device is for verifying calibration and assessing linearity of laboratory analyzers, not for diagnosing patient conditions.
No
The device description is not found, but the intended use clearly describes a physical product ("Five assayed levels... are provided") which are calibration verifiers for laboratory analyzers. This indicates a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for use in the "clinical laboratory to verify calibration and/or assess linearity of the Olympus® AU Analyzers." This indicates it's used in vitro (outside the body) to analyze samples (presumably patient samples run on the analyzers).
- Analyte Measurement: The product contains assayed levels of various proteins (Anti Streptolysin O, C-Reactive Protein, etc.) which are common analytes measured in clinical diagnostics.
- Purpose: The purpose is to "verify calibration and/or assess linearity," which are essential quality control steps for diagnostic tests performed on analyzers.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical Iaboratory to verify calibration and/or assess linearity of the Olympus® AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive Protein, Complement C3, Complement C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.
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
clinical Iaboratory
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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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 caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
JUL 2 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432-B South Mission Road Fallbrook, California 92028
Re: K031575
Trade/Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A - E for Olympus® AU Analyzers Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality, Control Material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: May 16, 2003 Received: June 3, 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, 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 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
2
510(k) Number (if known):
Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Olympus® AU Analyzers
Indications For Use:
CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical Iaboratory to verify calibration and/or assess linearity of the Olympus® AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive Protein, Complement C3, Complement C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Reeves for L. Bautista
Division of Clinical Laboratory Devices
510(k) Number K031575
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use