(27 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310). The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Immunodiagnostic Products Cortisol Range Verifiers are a base matrix of freeze-dried human plasma spiked with analyte (Cortisol) at low and high levels.
The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products Cortisol Range Verifiers. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.
The document focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, rather than presenting a detailed performance study with acceptance criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The text compares the intended use and matrix of the subject device to its predicate, but it does not specify any quantitative acceptance criteria or performance metrics for the VITROS Cortisol Range Verifiers themselves.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The 510(k) summary focuses on substantial equivalence based on device characteristics rather than a new performance study with a test set.
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):
This information is not provided in the document. As no detailed performance study with a test set is described, there's no mention of ground truth establishment or experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not applicable and not provided in the document. This device (range verifiers for an immunoassay system) is an in vitro diagnostic product, not an AI-assisted diagnostic tool that would involve human readers and MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided in the document. This is not an algorithm, but a physical diagnostic product. The document describes the "VITROS Immunodiagnostic System" as the instrumentation, but the subject device is the "Cortisol Range Verifiers" used with that system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of the Study (as described in the document):
The document does not describe a clinical performance study with defined acceptance criteria and detailed quantitative results. Instead, it discusses a substantial equivalence comparison study to a predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers, K973517).
- Study Goal: To demonstrate that the VITROS Immunodiagnostic Products Cortisol Range Verifiers are substantially equivalent to the predicate device.
- Methodology: Equivalence was demonstrated by comparing the physical properties and intended uses of the subject device with the predicate device and other commercially available reagents.
- Key Comparisons (from Table 1):
- Intended Use: Both devices are for verifying the calibration range of the VITROS Immunodiagnostic System for the measurement of a particular analyte (Cortisol for the subject device, FSH for the predicate).
- Matrix of Range Verifiers: Both use a base matrix of freeze-dried human plasma spiked with the respective analyte.
- Range Verifier Levels: Both have "Low and high" levels.
- Conclusion: The information presented in the pre-market notification (including these comparisons) was deemed sufficient to provide reasonable assurance that the VITROS Cortisol Range Verifiers are safe and effective for their stated intended use and are substantially equivalent to the predicate device.
In essence, the "study" described here is primarily a comparative analysis for regulatory clearance (510(k)) rather than a detailed performance validation study with specific acceptance criteria beyond demonstrating equivalence.
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Appendices
510(k) Summary (Appendix A)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K9840 |
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3607
Contact Person: Anne Zavertnik
Date 510(k) prepared: November 9, 1998
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Cortisol Range Verifiers. __ Common Name: Range Verifiers
Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.
3. Predicate Device
The VITROS Immunodiagnostic Products Cortisol Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products FSH Range Verifiers (K973517).
4. Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- l. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
Continued on next page
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510(k) Summary (Appendix A), Continued
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays, which include Cortisol.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device), which was approved by FDA (K973517) for IVD use.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Cortisol Range Verifiers with the predicate device, VITROS FSH Range Verifiers.
Continued on next page
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510(k) Summary (Appendix A), Continued
| Table 1 List of the assay characteristics | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------- | -- |
| DeviceCharacteristic | VITROS CORTISOLRange Verifiers | PredicateDevice |
|---|---|---|
| Intended use | For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of aparticular analyte(Cortisol). | For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH. |
| Matrix of Range Verifiers | A base matrix of freeze-dried human plasma spikedwith analyte (Cortisol). | A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH. |
| Range Verifier levels | Low and high | Low and high |
7. Conclusions
The information presented in the pre-market notification demonstrate that the VITROS Cortisol Range Verifiers are substantially equivalent to the predicate device, for which there is FDA clearance.
Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents.
The information presented in the premarket notification provide a reasonable assurance that the VITROS Cortisol Range Verifiers are safe and effective for the stated intended use.
ﺖ
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Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text is arranged in a circular pattern around the central image.
DEC 7 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anne Zavertnik Requlatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K984011 Trade Name: VITROS Immunodiagnostic Products Cortisol Range Verifiers Regulatory Class: I Product Code: JJX Dated: November 9, 1998 November 10, 1998 Received:
Dear Ms. Zavertnik:
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 leqally 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 aqainst 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 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 requlations.
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Page 2
This letter will allow you to beqin 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 Autman
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):
Device Name:
Indications for Use:
K 984011
VITROS Immunodiagnostic Products Cortisol Range Verifiers
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.
(Division Sign-Off)
vision of Clinical Laboratory Devices
(k) Number. 1298401/
Page 1 of 1
(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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
18
§ 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.