(30 days)
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions and for use as a consistent test sample of known concentration for monitoring assay convent use as a consistent toot bankplo of not of the many of control with patient serum in immunological ueterminations: intractions . The user can compare speciments when assaying for any of the noted of time as a means of evaluating analytical recovered values over and instrument performance.
Not Found
This is a letter acknowledging receipt and clearance of a 510(k) submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth that you're requesting.
The document indicates that the device, "Liquimmune® Liquid Assayed Immunoassay Control," is intended for use as a quality control material to monitor immunoassay conditions. As such, it's a control product, not a diagnostic device that would typically undergo a study to demonstrate sensitivity, specificity, or other performance metrics against a clinical ground truth in the way a diagnostic algorithm or device would.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided in the 510(k) submission, which would include data demonstrating the control's stability, reproducibility, and commutability (how well it behaves like patient samples in an assay). However, those specific study details are not present in this letter.
To provide the information you've requested, one would need access to the actual 510(k) submission (K011731) and its supporting documentation, which contains the detailed studies and data demonstrating the performance of the Liquimmune® control.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Darwin Richardson Vice President, Quality and Regulatory Affairs Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, California 93012
JUL - 5 2001
K011731 Re:
Trade Name: Liquimmune® Liquid Assayed Immunoassay Control Regulation Number: 21 CFR § 862.1150 Regulatory Class: I Product Code: JJY Dated: June 1, 2001 Received: June 5, 2001
Dear Mr. Richardson:
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 (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). 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 proiredion, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspoticility ato 2007 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 I his letter will and it you di substantial equivalence of your device to a legally marketed nontication. The PDF Intently of Scation 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 additionally 00911 odditionally, for questions on the promotion and advertising of your device, (201) 591 1500: Traditionaly) (namically) , mpliance 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 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 Sutman
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) Notification ● June 1, 2001 Liquid Assayed Immunoassay Control Levels 1, 2, and 3
Statement of Indications for Use
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is intended for i ri-Polit "" grano Liquinimum" Liquid Asourcentration for monitoring assay conditions
use as a consistent test sample of known concentration for monitoring assay convent use as a consistent toot bankplo of not of the many of control with patient serum in immunological ueterminations: intractions . The user can compare speciments when assaying for any of the noted of time as a means of evaluating analytical recovered values over and instrument performance.
V Hackett
(Division Sign-Off) Division of Clinical Laboratory Devices
上611731 510(k) Number-
(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_
(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.