(11 days)
CLINIQA LiniCAL™ Uric Acid Calibration Verifiers Levels A – E for Olympus AU Systems™ CLINIQA LiniCAL - Ont Atla Control products which may be used to evaluations are "assayed," liquid," quality" ontrol production with in the useful concentrations.
Not Found
This is a letter, not a study report. It states that the FDA reviewed a 510(k) premarket notification for the "LiniCAL™ Uric Acid Calibration Verifiers Levels A-E for Olympus AU Systems" and determined the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study. The letter is an FDA clearance, not a study report.
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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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 5 2004
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook CA 92028
K040455 Re:
Ro401935
Trade/Device Name: LiniCAL™ Uric Acid Calibration Verifiers Levels A-E for Olympus AU Systems 1M Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 14, 2004 Received: February 23, 20034
Dear Ms. Ruggiero:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your becermined the device 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 encreativent of 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). allu Cosmetter rear (110) the device, subject to the general controls provisions of the Act. The I out may, are beve, mains of the Act include requirements for annual registration, listing of general controls profitering 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 elassified (see wo roy als. Existing major regulations affecting your device can may be subject to badli addin at Pederal 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 I tease of the rised that I Bremination that your device complies with other requirements of the Act that 1 D'I has made a and regulations administered by other Federal agencies. You must or any I edetar statuated and regirements, including, but not limited to: registration and listing (21 Clift Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erequirements 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) I this letter will and in yourse FDA finding of substantial equivalence of your device to a legally premaired predicated 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 (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,
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
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510(k) Number (if known): 长ወዛዕዛડડ
Device Name: LiniCAL™ Uric Acid Calibration Verifiers Levels A – E for Olympus AU Systems™
Indications For Use:
CLINIQA LiniCAL™ Uric Acid Calibration Verifiers Levels A – E for Olympus AU Systems™ CLINIQA LiniCAL - Ont Atla Control products which may be used to evaluations are "assayed," liquid," quality" ontrol production with in the useful concentrations.
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD40455
(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
§ 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.