(32 days)
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.
Not Found
This document is a 510(k) clearance letter for the VITROS Immunodiagnostic Products Range Verifiers. Based on the provided text, the device is an in vitro diagnostic (IVD) product. The available information primarily focuses on regulatory clearance and intended use, rather than a detailed study description with specific acceptance criteria and performance data as might be found in a clinical trial report for an AI device.
Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included in this type of regulatory document for this kind of device.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
Based on the nature of the device (Range Verifiers for an immunodiagnostic system), the primary "acceptance criteria" for regulatory clearance would be substantial equivalence to a predicate device. The performance is assessed in terms of its ability to verify the calibration range for specific immunoassays.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Substantially equivalent to a legally marketed predicate device for verifying the calibration range of the VITROS Immunodiagnostic System. | The FDA found the device substantially equivalent for the stated indications for use (verifying calibration range for Free T4, Estradiol, CK-MB, and Ferritin immunoassays). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. As this is a range verifier, the "test set" would likely refer to internal validation data, which is not detailed here.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not specified for this type of IVD device regulatory clearance. Ground truth for a range verifier would be established through a comparison to a known standard or reference method, not typically by human experts interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an IVD device, not an algorithm, and its function is to verify calibration ranges.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a range verifier, the "ground truth" would be the expected concentration/range values of the analytes being measured, established through highly accurate reference methods or certified reference materials. The device is designed to confirm that the VITROS Immunodiagnostic System is performing within these established ranges.
8. The sample size for the training set
- Not applicable/not specified. This is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
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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 VITROSImmunodiagnostic System when used for the measurement ofimmunoassays which include Free T4, Estradiol, CK-MB andFerritin. |
(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
§ 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.