(47 days)
Not Found
K/DEN number is not in the document.
No
The provided text focuses on control materials for estimating test precision and detecting analytical deviations in the measurement of cyclosporin A and tacrolimus. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as control material used for estimating test precision and detecting analytical deviation in the measurement of cyclosporin A and tacrolimus, which indicates it is an in-vitro diagnostic tool, not a therapeutic device.
No
The device is described as a control material used to estimate test precision and detect analytical deviations in the measurement of substances like cyclosporin A and tacrolimus. This indicates it is used for quality control within a testing system, not for diagnosing a condition in a patient.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use describes control material for testing, which could be a physical substance or a software-based control system.
Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the control material is used "in the measurement of cyclosporin A and tacrolimus." These are substances measured in biological samples (like blood) to monitor drug levels, which is a classic application of in vitro diagnostics.
- Function: The control material is used to "estimate test precision" and "detect systematic analytical deviation." This is a quality control function for a diagnostic test system, which is a core component of IVD testing.
While the "Device Description" is missing, the intended use strongly points towards this being a control material used within an IVD test system. Control materials themselves are considered IVD devices as they are used in vitro to assess the performance of other IVD devices.
N/A
Intended Use / Indications for Use
The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument of cyclosporin A and tacrolimus.
Product codes
DIF, MKW
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
Not Found
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
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 6 1998
James W. Snipes Official Correspondent MORE Diagnostics, Inc. P.O.Box 6714 93412 Los Osos, California
K980331 Re : Immunosuppressant (Whole Blood) Control-Level 1, 2, 3, and 4 Regulatory Class: I & III Product Code: DIF, MKW March 2, 1998 Dated: Received: March 4, 1998
Dear Mr. Snipes:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨੇ substantially equivalent determination assumes compliance with would 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 comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page_ of ……
510(k) Number (if known): __
CycloA-Tac IMMUNOSUPPRESSANT CONTROL Device Name:_
Indications For Use:
The use of control material is necessary to estimate test precision in a test system and to The use of control material is licccssmy to commite to present or analytical instrument
detect systematic analytical deviation that may arise from reagent or analytical instr detect systematic analy noan of cyclosporin A and tacrolimus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | (Division Sign-Off) Division of Clinical Laboratory Devices |
| 510(k) Number | 510(k) Number |
| 98033 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |