(6 days)
Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid chemistry control material for monitoring the automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is an FDA 510(k) clearance letter for a "LiquiSPx Liquid Lipid Control" which is a chemical control material used in laboratory settings, not an AI/ML device. Therefore, I cannot fulfill your request based on the given input.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2001
Mr. James F. Godfrey Official Correspondent, Regulatory Affairs Clinical Controls Division 12038 Centralia Road Suite C Hawaiian Gardens, CA 90716
Re: K012855
Trade/Device Name: LiquiSPx Liquid Lipid Control Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: August 20, 2001 Received: August 24, 2001
Dear Mr. Godfrey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 nothleation. The I Dr I imating sification 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 1 IT you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This alagitestions on the promotion and advertising of your device, (2017) 594-1566. Fraunding 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 mormation on your responsibility on sumer 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): K012855
Device Name: LiquiSly Liquid Lipid Control
Indications For Use:
Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed Clinical Controls Liquior X Elquio Lipit Control and precision of lipid
chemistry control material for my the accuracy and precision of lipid chemistry control material for monitoring the assulting the automated analytical procedures.
Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and Lipid analysis consists of measuring to the diagnosis and management of
LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kusia Alexander/for Joan Cooper
Division Sign-Off
(Division Sign-Oft)
Division of Clinical Laboratory Devices
510(k) Number K012855
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.