(9 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description and intended use do not suggest such technology.
No
The device is described as "control material" used to estimate test precision and detect analytical deviations in a test system, indicating it is an analytical tool rather than a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is "control material... to estimate test precision... and to detect systematic analytical deviations," which indicates it is used for quality control or calibration of a test system, not for diagnosing a patient's condition.
Unknown
The provided text is a 510(k) summary template with most sections marked as "Not Found" or "Not Applicable". It only describes the intended use of a control material for estimating test precision and detecting analytical deviations. This description does not provide enough information about the device itself to determine if it is software-only. The "Device Description" section is missing, which would be crucial for this determination.
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 device is a "control material" used to "estimate test precision in a test system" and "detect systematic analytical deviations that may arise from reagent or analytical instrument variation." This description perfectly aligns with the purpose of control materials used in laboratory testing, which is a core component of in vitro diagnostics.
While other sections are "Not Found," the intended use alone strongly indicates that this device is designed to be used in vitro (outside the body) to assess the performance of a diagnostic test.
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 deviations that may arise from reagent or analytical instrument variation.
Product codes
JJT
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized caduceus symbol, featuring a staff with a snake winding around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 21 1998
James W. Snipes Official Correspondent MORE Diagnostics, Inc. P.O.Box 6714 93412 Los Osos, California
Re : K982845 Cardiac Markers Control (Single Use) Levels 1,2,3 Requlatory Class: I Product Code: JJT August 8, 1998 Dated: Received: August 12, 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Litman
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
| ﺮ
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
510(k) Number (if known): $98385
CARDIAC MARKERS CONTROL (SINGLE USE) THREE LEVELS Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| for smontgomery | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 4982845 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |