(33 days)
CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material.
CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are intended to evaluate the performance of assayed, liquid, quality control products on the Olympus AU Systems™.
Not Found
This is a 510(k) premarket notification for two types of quality control materials: "CLINIQA Liquid QC™ TDM Controls" and "CLINIQA LiniCAL™ TDM Calibration Verifiers." These devices are classified as Class I medical devices, which means they are subject to general controls but do not require extensive clinical trials or performance studies for market clearance. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than establishing specific performance criteria through a detailed study.
Therefore, the provided document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes, expert qualifications, or detailed ground truth methodologies. These types of detailed performance studies are typically required for higher-risk devices (Class II or Class III) with more extensive regulatory requirements.
Here's why the requested information isn't present in this document:
- Device Type: Quality control materials (like controls and calibrators) are used to monitor the performance of diagnostic assays. Their "performance" is generally assessed by their stability, homogeneity, and their ability to produce expected values when tested on analytical systems, rather than their diagnostic accuracy in a clinical context.
- Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence. This means the manufacturer shows their new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and, if applicable, performance data to the predicate, but not necessarily establishing de novo acceptance criteria and proving performance against them in a large-scale study as would be needed for a novel diagnostic device.
- Absence of Clinical Study Data: The document is a clearance letter, not a full submission. For Class I devices, the submission itself would contain limited performance data, usually focusing on analytical performance (e.g., stability studies, target value assignments, matrix effects) rather than clinical accuracy or reader studies.
In summary, based on the provided FDA clearance letter, I cannot provide the requested information because it is not typically required or present for this type of device and regulatory pathway.
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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 stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2004
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, CA 92028
Re: K041898
Ro 11076
Trade/Device Name: CLINIQA Liquid QCTM TDM Controls Levels 1,2&3 CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A- E for Olympus AU Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: July 12, 2004 Received: July 14, 2004
Dear Ms. Ruggiero:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave 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
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my yourse FDA finding of substantial equivalence of your device to a legally premailed predicated. " Thesults 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, rr you deens op the promotion and advertising of your device, please contact the Office of or questions on atte promice 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 I ou inay 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, MS, DVM.
Jean 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
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Ko41898 510(k) Number (if known):
Device Name: CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3
Indications For Use:
Indications i of Ose.
CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3 are intended for use as an CENNIQA Elquid QO - TDM Ooklools of Acetaminophen, Amikain, assayed quality control material: Thros a Ethosuximide, Gentamicin, Lidocaine, Lithium, Galbamazephic, Bloopyrainiae, Landon, Primidone, Procainamide, Quinidine, N-Acetyprocamamiac, I nonobalbital, P. Romany in are provided.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Allete Cuts
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation ar
510(k) K041898
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KO41898 510(k) Number (if known):
Device Name: CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™.
Indications For Use:
Indications For Ose.
CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are CEINIQA LIfliCAL - TDM Odibraton Vollions as realuate the performance of assayed, liquid, quality oontrol products minophen, Amikacin, Caffeine, Carbamazepine, Ine Olympus AO Systems - 16. 7866am.nop. Lithium, N-Acetylprocainemide, Digoxh, Disopyranhido, Valproic Acid and Vancomycin at five useful concentrations
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please DO not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert King
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041898
111
§ 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.