(54 days)
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
I am sorry, but the provided text from the FDA letter (K972608) refers to a RANDOX Assayed Specific Protein Control, which is a control material used for clinical chemistry applications. It is not a medical device that uses AI or requires the extensive studies (like MRMC, standalone performance, training sets, etc.) typically associated with AI-powered devices.
The document is an FDA clearance letter stating that the device is "substantially equivalent" to previously marketed devices. It does not contain information on:
- Acceptance criteria and reported device performance in the context of an AI study.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used (pathology, outcomes data, etc.).
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for details about acceptance criteria and studies using AI, as this information is not present in the provided document, which pertains to a different type of medical product.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. P. Armstrong Regulatory Affairs RANDOX LABORATORIES LTD. Ardmore, Diamond Road Crumlin, BT29 4QY Co. Antrim, N. IRELAND
AUG - 4 1997
Re: K972608 Trade Name: RANDOX Assayed Specific Protein Control Regulatory Class: II Product Code: JJY Dated: June 11, 1997 Received: June 11, 1997
Dear Dr. Armstrong:
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 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, qood 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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 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.
{1}------------------------------------------------
Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
: | | 利用通信息网 |
Page 2
{2}------------------------------------------------
| WALLERS ChargesJ11------------------------------------------------------------------------------------------------------------ | Page of 1 of 1 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------- |
510(k) Number (if known) __Not known
Device Name: _________________________________________________________________________________________________________________________________________________________________
SERUM - LOW/ELEVATED
Indications For Use :
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Makris
(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number K972608
Prescription Use V (Per 21 CFR 801.109)
:: 【 川崎東雄東国際】
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.