(41 days)
No
The summary describes a laboratory immunoassay system and its components for verifying calibration. There is no mention of AI, ML, or any related technologies in the intended use, device description, or the "Mentions AI, DNN, or ML" section.
No
The device is an in vitro diagnostic (IVD) system used to verify the calibration range of another diagnostic system. It does not provide any form of therapy or treatment.
No
This device, the VITROS Immunodiagnostic Products Range Verifiers, is intended for "verifying the calibration range of the VITROS Immunodiagnostic System." It is a quality control material used to ensure the proper functioning of a diagnostic system, rather than directly performing a diagnosis itself. The diagnostic system (VITROS Immunodiagnostic System) measures analytes, but this specific device only verifies its calibration.
No
The device description clearly outlines a system comprised of physical components: immunoassay kits (reagents, calibrators, verifiers), instrumentation (VITROS ECi Immunodiagnostic System), and common reagents. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro use." This is a key indicator of an IVD.
- Function: The device is used to "verify the calibration range" of a system that measures cardiac Troponin I (cTnl) in "human body fluids, commonly serum, plasma and urine." This involves testing samples outside of the human body to assess the performance of a diagnostic assay.
- Device Description: The description details components like "Immunodiagnostic Products Range Verifiers," "Reagent Pack," and "Calibrators," which are typical components of IVD systems used for laboratory testing.
- System Context: The device is part of the "VITROS Immunodiagnostic System," which is designed for the "quantitative and semi-quantitative determination of selected analytes in human body fluids." This entire system is clearly intended for diagnostic testing performed in a laboratory setting.
The purpose of this specific device (the Range Verifiers) is to ensure the accuracy and reliability of the diagnostic measurements performed by the VITROS system, which is a core function within the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnI).
Product codes
JJY
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).
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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).
1
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
2
510(k) Summary, Continued
| Table 1 List of the assay characteristics | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------- | -- | -- | -- | -- | -- | -- |
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Intended use | For use in verifying the | |
| calibration range of the | ||
| VITROS | ||
| Immunodiagnostic System | ||
| when used for the | ||
| measurement of cardiac | ||
| Troponin I | For use in verifying the | |
| calibration range of the | ||
| VITROS | ||
| Immunodiagnostic | ||
| System when used for the | ||
| measurement of FSH. | ||
| Matrix of Range Verifiers | A base matrix of a freeze | |
| dried human serum based | ||
| medium spiked with | ||
| analyte of human origin | A base matrix of freeze- | |
| dried human plasma | ||
| spiked with human | ||
| pituitary 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.
3
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.
4
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
5
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: