(38 days)
Not Found
No
The device is described as assayed, liquid, quality control products, and there is no mention of AI, ML, or related technologies in the summary.
No
The device is described as a "quality control product" used to "evaluate the performance of the Olympus AU Systems™" for various analytes, not for directly treating a medical condition.
No
The device is described as a quality control product used to evaluate the performance of laboratory systems. It does not directly diagnose a patient's condition.
No
The device description explicitly states it is "assayed, liquid, quality control products," indicating a physical, liquid substance, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the product is used to "evaluate the performance of the Olympus AU Systems™ for Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein". These are all substances measured in biological samples (in vitro) to provide information about a patient's health.
- Device Description: The description "assayed, liquid, quality control products" aligns with the nature of IVD products used for calibration and quality control in laboratory testing.
The fact that it's a "quality control product" for evaluating the performance of a diagnostic system further confirms its role within the IVD ecosystem.
N/A
Intended Use / Indications for Use
CLINIQA LiniCAL™ Esoterics 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 Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations.
Product codes
JJY
Device Description
Assayed, liquid, quality control products.
Mentions image processing
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing or supporting another figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 3 2004
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook, CA 92028
K040091 Re: K040071
Trade/Device Name: LiniCALTM Esoterics 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: JJY Dated: January 13, 2004 Received: January 16, 2004
Dear Ms. Ruggiero:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases 976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, and excordance with the provisions of the Federal Food, Drug, devices that have been reciasined require approval of a premarket approval application (PMA). and Costicule Act (110.) that to nevies, subject to the general controls provisions of the Act. The r our may, diererere, mains of the Act include requirements for annual registration, listing of general controls proving 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 If your device is olusified (600 acc roy ols. Existing major regulations affecting your device can may oe subject to suel adentifical 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 r lease oc advised that 1 Dr. 5 issuanted evour device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I cut all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Tec of CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), iaooning (21 the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I has letter with and in yourse FDA finding of substantial equivalence of your device to a legally prematicated 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, If You desire spoonie navertising 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 Tou may 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,
Jean M. Cooper, US, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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™ Esoterics Calibration Verifiers Levels A – E for Olympus AU Systems™
Indications For Use:
CLINIQA LiniCAL™ Esoterics 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 Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations.
Alberto Lutz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040091
(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