(101 days)
P850048
No
The summary describes a standard in vitro diagnostic immunoassay system and does not mention any AI or ML components or capabilities.
No
This device is an in vitro diagnostic assay used for the quantitative measurement of PSA to aid in the management of prostate cancer. It does not directly treat or alleviate symptoms of a disease, which is the primary function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for the quantitative measurement of prostate specific antigen (PSA)... to aid in the management of patients with prostate cancer," which directly indicates its use in diagnosis or management of a disease.
No
The device description explicitly states it is comprised of three main elements, including "The VITROS Immunodiagnostic System instrumentation," which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Vitros® PSA is an "in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma...". The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of the living organism.
- Device Description: The description details a system that uses "luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine." This describes a laboratory-based test performed on biological samples.
- Components: The device is comprised of reagents, calibrators, and instrumentation used to perform an assay on human body fluids. These are typical components of an IVD system.
The entire description points to a test performed in a laboratory setting on patient samples (serum or plasma) to provide diagnostic information (measurement of PSA to aid in the management of prostate cancer patients). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.
Product codes
LTJ
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 or 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 PSA Reagent Pack, VITROS Immunodiagnostic Products PSA Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS PSA assay).
-
- 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.
- 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to Predicate Device: The relationship between the VITROS PSA assay and the predicate device, determined by Bablock Passing, is: VITROS PSA assay = 1.028 x [the Tandem-R PSA assay] -- 0.089 (ng/mL), with a correlation coefficient of 0.989. Comparisons of the VITROS PSA assay and the predicate device were performed with samples from a variety of clinical categories. Tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values.
The data presented demonstrate that the VITROS PSA assay performs substantially equivalent to the approved predicate device. Equivalence was demonstrated using currently commercially available reagents along with patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation. In clinical studies of apparently healthy individuals, patients with malignant disease and patients with a variety of non-malignant diseases, the VITROS PSA assay exhibited distribution results that parallel expected distributions for these patient types. The serial monitoring study demonstrated that the VITROS PSA assay is substantial equivalent to the predicate device in patients previously treated for prostate cancer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: VITROS PSA assay 0.02 ng/mL, Predicate Device 0.1 ng/mL
Predicate Device(s)
P850048
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
ADMINISTRATIVE 1
1.1 510(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: K984889
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 30, 1998
2. Device Name
Trade or Proprietary Name: VITROS® Immunodiagnostic Products PSA Calibrators VITROS® Immunodiagnostic Products PSA Reagent Pack
Common Name: PSA assay
Classification Name: test for the in vitro quantitative determination of prostate specific antigen in serum or plasma.
3. Predicate Device
The VITROS Immunodiagnostic Products PSA assay is substantially equivalent to the Hybritech Tandem®-R PSA (P850048).
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 or 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 PSA Reagent Pack, VITROS Immunodiagnostic Products PSA Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS PSA assay).
1
-
- 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
The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products PSA assay is substantially equivalent to Hybritech Tandem-R PSA (predicate device), which was approved by FDA (P850048) for IVD use.
The relationship between the VITROS PSA assay and the predicate device, determined by Bablock Passing, is:
VITROS PSA assay = 1.028 x [the Tandem-R PSA assay] -- 0.089 (ng/mL), with a correlation coefficient of 0.989.
Comparisons of the VITROS PSA assay and the predicate device were performed with samples from a variety of clinical categories.
In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS PSA assay package insert for VITROS PSA assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS PSA assay with the predicate device:
2
| Device
Characteristic | VITROS PSA assay | Predicate
Device |
|--------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Calibration range | 0 - 100 ng/mL | 0 - 100 ng/mL |
| Basic principle | Solid phase immunoassay | Solid phase
immunoradiometric assay |
| Sample type | Serum, plasma (heparin or
EDTA) | Serum |
| Antibody | l) Two mouse monoclonal
anti-PSA antibodies in
biotinylated antibody
reagent | l) Mouse monoclonal
anti-PSA antibody coated
onto plastic beads |
| | 2) Goat polyclonal anti-
PSA antibody in conjugate
reagent | 2) Radiolabeled mouse
monoclonal anti-PSA in
protein matrix |
| Sample volume | 15 uL | 50 uL |
| Analytical sensitivity | 0.02 ng/mL | 0.1 ng/mL |
Table 1 List of the assay characteristics
7. Conclusions
The data presented in the premarket notification demonstrate that the VITROS PSA assay performs substantially equivalent to the approved predicate device.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation. In clinical studies of apparently healthy individuals, patients with malignant disease and patients with a variety of non-malignant diseases, the VITROS PSA assay exhibited distribution results that parallel expected distributions for these patient types.
The serial monitoring study demonstrated that the VITROS PSA assay is substantial equivalent to the predicate device in patients previously treated for prostate cancer.
The data presented in the premarket notification provide a reasonable assurance that the VITROS PSA assay is safe and effective for the stated intended use.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized figures that appear to be birds or abstract human figures. The figures are arranged in a vertical stack, with the top figure being the largest and the bottom figure being the smallest.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 2 1999
Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester NY 14626-5101
Re: K984289
Trade Name: VITROS Immunodiagnostic Products PSA Calibrators VITROS Immunodiagnostic Products PSA Reagent Pack Regulatory Class: II Product Code: LTJ Dated: February 26, 1999 Received: March 1, 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page 1 of 1
1.2 Indications For Use Statement
510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products PSA Reagent Pack VITROS Immunodiagnostic Products PSA Calibrators
1484289
Indications for Use:
The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.
Tita E. Makeri
(Division Sign Off)
(Division Sign-Off) (Division Sign of Clinical Laboratory Dev 84289 510(k) Number
(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)