(40 days)
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Not Found
No
The document describes a control serum for laboratory assays and contains no mention of AI or ML.
No
The device is described as an assayed control serum for monitoring immunoassay and general chemistry assays in a clinical laboratory, not for treating any medical condition.
No
Explanation: The device is described as an assayed control serum used for monitoring immunoassay and general chemistry assays to assure consistent performance of reagents and instruments, not to diagnose a patient condition.
No
The device is described as a control serum for monitoring immunoassay and general chemistry assays, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use explicitly states that it is "intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays." This aligns with the definition of an IVD, which 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.
Control materials like this are used to verify the accuracy and precision of diagnostic tests performed on patient samples, which is a crucial part of the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
CardioImmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays. Include CardioImmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes
JJT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 30 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scot D. Kinghorn Vice President, Quality and Regulatory Affairs Medical Analysis Systems, Inc. 542 Flynn Road Camarillo, California 93012
K992430 Re:
Trade Name: CardioImmune Cardiac Marker Control Levels 1, 2, and 3 Regulatory Class: I Product Code: JJT Dated: July 16, 1999 Received: July 21, 1999
Dear Mr. Kinghorn:
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 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 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 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.
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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/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__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
510(k) Notification ● July 16, 1999 Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3
Statement of Indications for Use
Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.
Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suter E. Mason
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K992430 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| ------------------ | --- |
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)