(13 days)
For in vitro diagnostic use only. VITROS TDM Performance Verifiers are designed for use in assessing bias (mean) and impersion (standard deviation) for each reagent lot. Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet.
Not Found
This document is an FDA 510(k) clearance letter for the VITROS Chemistry Products TDM Performance Verifiers. It primarily focuses on regulatory approval rather than providing a detailed technical study report.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
The document does include a "Statement of Intended Use" which mentions how the device is designed to be used and how its performance is assessed in a general sense.
Here's what can be inferred or directly stated from the provided pages, as well as what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not contain a table of acceptance criteria.
- Inference from "Indications for Use":
- Acceptance Criteria (Implied Function): The device is intended for "assessing bias (mean) and imprecision (standard deviation) for each reagent lot." This implies that the 'acceptance criteria' for the performance verifiers themselves would be related to their stability, consistency, and ability to accurately reflect known TDM values for quality control.
- Reported Device Performance: "Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet." This indicates that the performance of the test system (VITROS Chemistry Products with TDM Performance Verifiers) is evaluated by comparing results from the verifiers against established "assay sheet" values, which are themselves derived from interlaboratory studies. However, the specific performance metrics (e.g., specific bias and CV% thresholds) are not given here.
2. Sample sized used for the test set and the data provenance
- Cannot be provided. The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). The mention of "interlaboratory performance data" suggests multiple labs contributed, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. The document does not mention the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for the test set
- Cannot be provided. The document does not describe any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- Cannot be provided. This type of study is not mentioned. The device is a "Performance Verifier" (quality control material), not a diagnostic algorithm typically evaluated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Cannot be provided. This device is a consumable diagnostic product (a "verifier" or control material), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used
- Inference: The "Indications for Use" states: "Published values are derived from interlaboratory performance data." This implies the ground truth for the performance verifiers' expected values (the "assay sheet" values) are established through interlaboratory consensus/comparison using various reference methods and potentially reference materials.
8. The sample size for the training set
- Not applicable/Cannot be provided. This is a quality control material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. As above, this is not an AI/ML algorithm. The "ground truth" for the verifiers themselves (their expected values) would be established through robust analytical methods and interlaboratory comparisons, but the specifics are not in this document.
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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 2 1998
Charles C. Morqanson, Jr., RAC · Requlatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101
Re : K982649 VITROS Chemistry Products TDM Performance Verifiers I, II, and III Requlatory Class: I Product Code: DIF Dated: July 29, 1998 Received: July 30, 1998
Dear Mr. Morganson:
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. A 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 Druq 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 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
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Statement of Intended Use
Page 1_of 1
510(k) Number (if known): K19831649
VITROS Chemistry Products TDM Performance Verifiers Device Name:
Indications for Use:
Intended Use:
For in vitro diagnostic use only.
VITROS TDM Performance Verifiers are designed for use in assessing bias (mean) and impersion (standard deviation) for each reagent lot. Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet.
Summary and Explanation of the Test:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use _(Per 21 CFR 801.109) | ✓ |
|---|---|
| -------------------------------------------- | -------------- |
OR
| Over-The-Counter Use _ | (Optional Format 1-2-96) |
|---|---|
| ------------------------ | -------------------------- |
(Division of General, Restorative,
Neurological and Physical Medicine Devices)
510(k) Nutabel
§ 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.