(27 days)
No
The description focuses on the immunoassay technology, instrumentation, and reagents, with no mention of AI or ML.
No
The device is described as being "For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System" and is part of an immunoassay system. It does not exert a therapeutic effect on a patient.
No
The device is described as "For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System" which suggests it is used for quality control or calibration of a diagnostic system, rather than directly performing a diagnosis itself.
No
The device description clearly outlines hardware components (VITROS Immunodiagnostic System instrumentation, coated microwells, reagent packs, calibrators, etc.) and physical reagents, indicating it is 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" explicitly states "For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System...". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a product used with an "Immunodiagnostic System" for the "quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine." This is the core function of many IVD devices.
- Type of Product: The device is described as "VITROS Immunodiagnostic Products Cortisol Range Verifiers," which are used to verify the calibration of an immunoassay system. Calibration verification materials are a common type of IVD accessory or control.
- Predicate Device: The predicate device listed (K973517; VITROS Immunodiagnostic Products FSH Range Verifiers) is also an IVD, further supporting the classification of this device.
Therefore, based on the provided information, this device clearly falls under the definition of an In Vitro Diagnostic.
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 immunoassays which include Cortisol.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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:
- l. 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).
-
- 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
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: K9840 |
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 9, 1998
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Cortisol 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 Cortisol.
3. Predicate Device
The VITROS Immunodiagnostic Products Cortisol 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:
- l. 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).
Continued on next page
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
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays, which include Cortisol.
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 Cortisol Range Verifiers with the predicate device, VITROS FSH Range Verifiers.
Continued on next page
2
510(k) Summary (Appendix A), Continued
| Table 1 List of the assay characteristics | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------- | -- |
| Device
Characteristic | VITROS CORTISOL
Range Verifiers | Predicate
Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in verifying the
calibration range of the
VITROS
Immunodiagnostic System
when used for the
measurement of a
particular analyte
(Cortisol). | 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 freeze-
dried human plasma spiked
with analyte (Cortisol). | 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 information presented in the pre-market notification demonstrate that the VITROS Cortisol 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 information presented in the premarket notification provide a reasonable assurance that the VITROS Cortisol Range Verifiers are safe and effective for the stated intended use.
ﺖ
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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 the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text is arranged in a circular pattern around the central image.
DEC 7 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anne Zavertnik Requlatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K984011 Trade Name: VITROS Immunodiagnostic Products Cortisol Range Verifiers Regulatory Class: I Product Code: JJX Dated: November 9, 1998 November 10, 1998 Received:
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 leqally 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 requlations.
4
Page 2
This letter will allow you to beqin 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 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
5
Statement of Intended Use (Appendix C)
510(k) Number (if known):
Device Name:
Indications for Use:
K 984011
VITROS Immunodiagnostic Products Cortisol Range Verifiers
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.
(Division Sign-Off)
vision of Clinical Laboratory Devices
(k) Number. 1298401/
Page 1 of 1
(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) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
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