(28 days)
No
The document describes a standard immunoassay system and does not mention any AI or ML components.
No
Explanation: This device is an in vitro diagnostic (IVD) assay designed for quantitative measurement of testosterone in human samples. It does not provide any therapeutic function or directly treat a disease or condition.
Yes
Explanation: The device is intended for the quantitative measurement of testosterone in human serum or plasma, which provides information used for diagnosis or monitoring of a disease or condition. The "Intended Use / Indications for Use" section explicitly states "in vitro quantitative measurement of testosterone," and such measurements are inherently diagnostic in nature when applied to patient samples. Furthermore, the "Summary of Performance Studies" mentions "samples from a variety of clinical categories," implying its use in a clinical diagnostic context.
No
The device description clearly outlines a system comprised of reagent packs, calibrators, and instrumentation, indicating a hardware-based immunoassay 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 that the assay is for the "in vitro quantitative measurement of testosterone in human serum or plasma". "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs.
- Device Description: The description details a system that uses reagents and instrumentation to perform an assay on human body fluids (serum or plasma). This is consistent with the nature of IVD devices.
- Predicate Device: The mention of a "predicate device" (K813401; DPC Coat-A-Count Testosterone assay) which is also an assay for testosterone, further indicates that this device falls within the category of IVDs. Predicate devices are used in the regulatory process for new IVDs.
N/A
Intended Use / Indications for Use
The VITROS TESTOSTERONE assay is intended for the in vitro quantitative measurement of testosterone in human serum or plasma (EDTA or heparin).
Product codes (comma separated list FDA assigned to the subject device)
3JY, CDZ, JIX
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 TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE 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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparisons of the VITROS TESTOSTERONE 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 TESTOSTERONE assay package insert for VITROS TESTOSTERONE assay results.
The data presented in the pre-market notification demonstrate that the VITROS TESTOSTERONE assay performs substantially equivalent to the predicate device, for which there is FDA clearance.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KA983807
NOV 4 1999
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: H98350 7
- 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: September 21, 1998
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products TESTOSTERONE assay Common Name: Testosterone assay
Classification Name: TESTOSTERONE assay for the in vitro quantitative measurement of testosterone in human serum and plasma (EDTA or heparin).
3. Predicate Device
The VITROS Immunodiagnostic Products TESTOSTERONE assay is substantially equivalent to DPC Coat-A-Count Testosterone assay (K813401).
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 TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE assay).
Continued on next page
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE assay).
1
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
The VITROS TESTOSTERONE assay is intended for the in vitro quantitative measurement of testosterone in human serum or plasma (EDTA or heparin).
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products TESTOSTERONE assay is substantially equivalent to DPC Coat-A-Count Testosterone assay (predicate device), which was approved by FDA (K813401) for IVD use.
The relationship between the VITROS TESTOSTERONE assay and the predicate device, determined by Deming's Regression, is:
VITROS TESTOSTERONE assay = 0.9222 x DPC Coat-A-Count Testosterone assay - 2.25 nmol/L
Comparisons of the VITROS TESTOSTERONE 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 TESTOSTERONE assay package insert for VITROS TESTOSTERONE assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS TESTOSTERONE assay with the predicate device, DPC Coat-A-Count Testosterone assay.
Continued on next page
2
510(k) Summary (Appendix A), Continued
| Device | VITROS | Predicate |
|---|---|---|
| Characteristic | TESTOSTERONE assay | Device |
| Calibration range | 0-75 nmol/L | 0.7 - 55 nmol/L |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Radio labeled |
| Instrumentation | VITROS | Microwell plate reader |
| Immunodiagnostic System | ||
| Sample type | Serum, plasma (EDTA or | Serum, plasma (heparin) |
| heparin) | ||
| Antibody | Mouse monoclonal anti- | Polyclonal anti- |
| testosterone antibody | testosterone antibody | |
| biotinylated antibody | coated onto | |
| reagent. | polypropylene tubes. | |
| Sample volume | 25 uL | 50 uL |
| Incubation time and | 16 minutes at 37° C | 3 hours at 37° C |
| temperature |
Table 1 List of the assay characteristics
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS TESTOSTERONE assay performs substantially equivalent to the predicate device, for which there is FDA clearance.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.
The data presented in the premarket notification provide a reasonable assurance that the VITROS TESTOSTERONE assay is safe and effective for the stated intended use.
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Public Health Service
Image /page/3/Picture/1 description: The image shows the Department of Health & Human Services logo and text. The text includes the department's name and the date NOV 4 1998. The logo is a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anne Zavertnik Requlatory Affairs Associate Ortho-Clinical Diaqnostics, Inc. Requlatory Affairs MC00882 100 Indigo Creek Drive Rochester, New York 14626-5101
к983507 Re: Trade Name: VITROS Immunodiagnostic Products TESTOSTERONE Assay Product Code: 3JY Requlatory Class: I CDZ I II JIX Dated: October 6, 1998 Received: October 7, 1998
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 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 regulations.
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Page 2
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 requlation (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 Putman
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
A.L.I
5
Statement of Intended Use (Appendix D)
(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)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983507 |
Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Testosterone Reagent Pack VITROS Immunodiagnostic Products Testosterone Calibrators VITROS Immunodiagnostic Products Testosterone Controls