(16 days)
- For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of DF3 defined antigen.
- For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of OC 125 defined antigen.
- For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of PSA.
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 System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided document is a 510(k) summary for "VITROS Immunodiagnostic Products CA 15-3 Range Verifiers, VITROS Immunodiagnostic Products CA 125 II Range Verifiers, and VITROS Immunodiagnostic Products PSA Range Verifiers."
This document describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. It does not present acceptance criteria for device performance or a study proving that the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence based on physical properties, intended use, and comparison with a previously cleared predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers, K973517).
Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment from this submission. These details would typically be found in a performance study report, which is not part of this 510(k) summary.
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3/25/99
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: H990783 .
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3790
Contact Person: Anne Zavertnik
Date 510(k) prepared: March 4, 1999
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products CA 15-3™ Range Verifiers: VITROS Immunodiagnostic Products CA 125 II™ Range Verifiers, and VITROS Immunodiagnostic Products PSA 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 CA 15-3, CA 125 II and PSA.
3. Predicate Device
The VITROS Immunodiagnostic Products CA 15-3, CA 125 II and PSA 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 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).
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- 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 (K964310).
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 DF3 defined antigen, OC 125 defined antigen or PSA.
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 CA 15-3. CA 125 II and PSA Range Verifiers with the predicate device, VITROS FSH Range Verifiers.
Continued on next page
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510(k) Summary, Continued
| DeviceCharacteristic | VITROS CA 15-3, CA125 II AND PSA RangeVerifiers | PredicateDevice |
|---|---|---|
| Intended use | For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of aparticular analyte (see page11 for a list of analytes). | For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH. |
| Matrix of Range Verifiers | A liquid buffered matrixspiked with analyte (seepage 11 for full details). | A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH. |
| Range Verifier levels | Low and high | Low and high |
Table 1 List of the assay characteristics
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS CA 15-3, CA 125 II and PSA 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 CA 15-3, CA 125 II and PSA Range Verifiers are safe and effective for the stated intended use.
4
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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 a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
MAR 2 5 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101
K990783 Re:
Trade Name: VITROS Immunodiagnostic Products CA 15-3 Range Verifiers VITROS Immunodiagnostic Products CA 125 II Range Verifiers VITROS Immunodiagnostic Products PSA Range Verifiers
Regulatory Class: I Product Code: JJX Dated: March 4, 1999 Received: March 9, 1999
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 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 K 990783 510(k) Number (if known): 1. VITROS Immunodiagnostic Products CA 15-3 Range Verifiers Device Name: 2. VITROS Immunodiagnostic Products CA 125 II Range Verifiers 3. VITROS Immunodiagnostic Products PSA Range Verifiers 1. For in vitro use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of DF3 defined antigen. 2. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of OC 125 defined antigen. 3. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of PSA.
(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 | K990783 |
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | ---------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
§ 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.