(51 days)
Not Found
Not Found
No
The document describes a therapeutic drug calibrator, which is a laboratory reagent used for calibration. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a calibrator for therapeutic drug assays, not a therapeutic device itself. It is used for calibration, not for treating or diagnosing patients.
No
Explanation: The device is described as a calibrator for therapeutic drug assays, not a diagnostic device itself. Its purpose is to calibrate other assays, not to diagnose a condition.
No
The device description explicitly states it is a "Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays," indicating a physical, biological product, not software.
Based on the provided information, the Randox Laboratories Limited Therapeutic Drug Calibrators are likely considered IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states "for use in the calibration of therapeutic drug assays." Therapeutic drug assays are performed on biological samples (like blood or urine) in vitro (outside the body) to measure the concentration of drugs. Calibrators are essential components of these assays to ensure accurate results.
- Device Description: The description reinforces its use in calibrating therapeutic drug assays.
- Intended User: The intended user is "suitably qualified laboratory personnel under appropriate laboratory conditions," which is typical for IVD products used in clinical or analytical laboratories.
While the document doesn't explicitly state "In Vitro Diagnostic," the function and intended use of a calibrator for therapeutic drug assays strongly align with the definition of an IVD. IVDs are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Calibrators are crucial for the accurate performance of diagnostic tests.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Therapeutic Drug Calibrators are based on Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels.
The Randox Laboratories Limited Therapeutic Drug Calibrator should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
DBK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitably qualified laboratory personnel under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Pauline Armstrong, Ph.D. Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY
SEP 1 2 2001
Re: K012318
Trade/Device Name: Therapeutic Drug Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DBK Dated: July 11, 2001 Received: July 23, 2001
Dear Ms. Kindell:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
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 1 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/cdrb/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
2
Page 1 of 1
510(k) Number (if known) NOT KNOWN
Device Name
THERAPEUTIC DRUG CALIBRATOR
Indications For Use :
The Randox Laboratories Limited Therapeutic Drug Calibrators are based on Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels.
The Randox Laboratories Limited Therapeutic Drug Calibrator 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)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format1-2-96)
Kenia Alexander Shalton Crozier
(Division Sign-Off)
vision of Clinical Lab 510(k) Number