(41 days)
Assayed for use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnl). For in vitro use.
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:
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS ECi 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 (K964310).
The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VITROS Immunodiagnostic Products Troponin I Range Verifiers:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary does not contain performance acceptance criteria or a specific study demonstrating that the device meets those criteria in the traditional sense of a clinical or analytical performance study. This submission is for Range Verifiers, which are quality control materials used to verify the calibration range of an existing immunodiagnostic system (VITROS Immunodiagnostic System) for a specific analyte (Troponin I).
Instead of demonstrating a specific diagnostic performance (like sensitivity or specificity), the submission focuses on substantial equivalence to a predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers) based on physical properties and intended use. The "study" here is essentially a comparison study against the predicate device to establish equivalence, rather than a de novo performance study.
Therefore, many of the requested fields cannot be filled as they pertain to performance studies that were not conducted or reported in this 510(k) summary for this specific type of device (range verifiers).
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit acceptance criteria and corresponding performance metrics for the Troponin I Range Verifiers (e.g., accuracy, precision, stability) are not detailed in this 510(k) summary. The summary states that "Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents." This implies that the 'acceptance' was based on the similarity of the new device to the already-cleared predicate device in terms of its characteristics as range verifiers.
| Acceptance Criterion | Reported Device Performance (as implied by equivalence) |
|---|---|
| Intended Use | For use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I. (Matches predicate in function, differs in specific analyte) |
| Matrix | A base matrix of a freeze-dried human serum-based medium spiked with analyte of human origin. (Similar to predicate's freeze-dried human plasma base spiked with human analyte) |
| Levels | Low and high. (Matches predicate) |
| Safety and Effectiveness | Deemed "safe and effective for the stated intended use" based on substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission concerns range verifiers, which are control materials, not a diagnostic test device with a "test set" of patient data. The comparison was against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There was no "test set" of patient data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
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 device is a quality control material, not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
Not applicable. No ground truth for diagnostic performance was established for this device; instead, the ground for approval was an assessment of substantial equivalence to an existing legally marketed device (the VITROS FSH Range Verifiers) based on their intrinsic properties as quality control materials.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of an algorithm or diagnostic model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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Chapter 1 -- Summary Information
510(k) Summary
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: K99234 9
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-4041
Contact Person: Marlene Shulman
Date 510(k) prepared: July 13, 1999
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Troponin I 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 Troponin I.
3. Predicate Device
The VITROS Immunodiagnostic Products Troponin I 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:
-
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
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510(k) Summary, Continued.
-
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS ECi 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 (K964310).
The VITROS ECi 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 inverifying the galibration range of the VITROS (mmunodiag when used for the measurement of cardias Troponin (c In).
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 Troponin I Range Verifiers with the predicate device, VITROS FSH Range Verifiers.
Continued on next page
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510(k) Summary, Continued
| Table 1 List of the assay characteristics | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------- | -- | -- | -- | -- | -- | -- |
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Intended use | For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of cardiacTroponin I | For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH. |
| Matrix of Range Verifiers | A base matrix of a freezedried human serum basedmedium spiked withanalyte of human origin | A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH. |
| Range Verifier levels | Low and high | Low and high |
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Troponin I 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 data presented in the premarket notification provide a reasonable assurance that the VITROS Troponin I Range Verifiers are safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines representing hair or clothing.
AUG 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics A Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101
K992349 Re:
Trade Name: VITROS Immunodiagnostic Products Troponin I Range Verifiers Regulatory Class: I Product Code: JJY Dated: July 13, 1999 Received: July 14, 1999
Dear Ms. Shulman:
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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Page 2
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
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Statement of intended Use
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | VITROS Immunodiagnostic Products Troponin I Range Verifiers |
Assayed for use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnl). For in vitro use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| tes E. Maxim | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992349 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
ン:
§ 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.