(32 days)
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No
The summary describes a calibration verification material for an immunoassay system and contains 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 being "for in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays". This indicates it is a quality control or calibration tool for diagnostic equipment, not a device used for treating a disease or condition in a patient.
No
Explanation: The device is described as "for in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System." This indicates it is a calibration or quality control device for another diagnostic system, rather than a diagnostic device itself.
No
The intended use describes a device for in vitro use in verifying the calibration range of an immunodiagnostic system. This strongly suggests a physical component (e.g., a calibrator solution or material) is involved, not just software. The lack of a device description prevents definitive confirmation, but the context points away from a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states:
"For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays..."
The phrase "For in vitro use" is the key indicator that this device is intended to be used outside of the body to examine specimens, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Free T4, Estradiol, CK-MB and Ferritin.
Product codes
JJX
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
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
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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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 3 1998
Ann Quinn Manager, Regulatory Affairs Johnson & Johnson Clinical Diagnostics, Inc. 100 Indigo Creek Rochester, New York 14650
K974644 Re : VITROS Immunodiagnostic Products Range Verifiers Requlatory Class: I Product Code: JJX Dated: December 11, 1997 December 12, 1997 Received:
Dear Ms. Quinn:
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ 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 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 requlations.
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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 requlation (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 Other general premarket notification" (21 CFR 807.97). 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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Statement of Intended Use (Appendix C)
510(k) Number (if known): | Page 1 of 1 |
---|---|
Device Name: | VITROS Immunodiagnostic Products Range Verifiers |
Indications for Use: | For in vitro use in verifying the calibration range of the VITROS |
Immunodiagnostic System when used for the measurement of | |
immunoassays which include Free T4, Estradiol, CK-MB and | |
Ferritin. |
(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,
510(k) Number | K974644 |
---|---|
--------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | ✓ |
---|---|
------------------------------------------ | ---------------------------------------------------- |
OR
Over-The-Counter Use | |
---|---|
---------------------- | --------------------------------------------------- |
(Optional Format 1-2-96)ﺮ