(22 days)
CLINIQA Liquid-QC™ hCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.
CLINIQA Liquid-QC™ hCG Control Levels 1, CLINIQA Liquid-QC™ hCG Control Levels 2, CLINIQA Liquid-QC™ hCG Control Levels 3
The provided text is a 510(k) premarket notification letter from the FDA regarding CLINIQA Liquid-QC™ hCG Control Levels 1, 2, and 3. This document confirms the substantial equivalence of the device to a predicate device and allows it to be marketed.
However, the letter does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving a device meets acceptance criteria.
This type of FDA letter is an administrative approval based on the device being "substantially equivalent" to an already legally marketed device (the "predicate device"). It means the new device has the same intended use and technological characteristics as the predicate, or if it has different characteristics, these do not raise new questions of safety and effectiveness. The detail about performance criteria and specific studies demonstrating those criteria are typically found in the 510(k) submission itself, not in the FDA's decision letter.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document is about the regulatory approval, not the detailed performance study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 01 2002
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqua Corporation 1432 South Mission Road Fallbrook, CA 92028
K022232 Re:
Trade/Device Name: CLINIQA Liquid-QC™ hCG Control Levels 1 CLINIQA Liquid-QCTM hCG Control Levels 2 CLINIQA Liquid-QCTM hCG Control Levels 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unasayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: July 3, 2002 Received: July 10, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KOJJJ232
Device Name:
CLINIQA Liquid-QC™ hCG Control Level 1 CLINIQA Liquid-QC™ hCG Control Level 2 CLINIQA Liquid-QC™ hCG Control Level 3
Indications For Use:
CLINIQA Liquid-QC™ hCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.
(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
for Joe Kennel Sheriff
(Division Sign Off)
ivision Sign-Off) Division of Clinical Laboratory Devices
510(k) Number Lezzzz
§ 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.