(24 days)
No
The summary describes a standard immunoassay system and reagents, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
Explanation: The device is an in vitro diagnostic (IVD) product that quantitatively measures progesterone in human serum and plasma for diagnostic purposes, not for direct therapeutic intervention on a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
No
The device description clearly outlines a system comprised of reagent packs, calibrators, and instrumentation (the VITROS Immunodiagnostic System), all of which are physical components. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use only." for the VITROS Progesterone Reagent Pack.
- "For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma..." for the VITROS Progesterone Calibrators.
These statements clearly indicate that the device is intended for use outside of the body to diagnose or aid in the diagnosis of a condition, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA or heparin).
Product codes
JIS
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 and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- 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 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only 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)
Equivalence was demonstrated using manufactured reagents along with patient samples with measured Progesterone values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Progesterone assay (modified) for use with human serum and plasma is safe and effective for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
SEP 2 7 2002
·
KO22901
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: _________________.
| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, New York 14626-5101
(585) 453-4041 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Marlene A. Hanna |
| 2. Preparation date | Date Special 510(k) prepared: 30 August 2002 |
| 3. Device name | Trade or Proprietary Name:
VITROS Immunodiagnostic Products Progesterone Reagent Pack
VITROS Immunodiagnostic Products Progesterone Calibrators |
| | Common Name : Progesterone assay
Classification Name: Progesterone test system ( 21 CFR 862.1620). |
| 4. Predicate device | The VITROS Immunodiagnostic Products Progesterone Reagent Pack (new formulation) and VITROS Immunodiagnostic Products Progesterone Calibrators (new formulation) are substantially equivalent to the VITROS Immunodiagnostic Products Progesterone Reagent Pack (original formulation) and VITROS Immunodiagnostic Products Progesterone Calibrators (original formulation). |
Continued on next page
1
510(k) Summary, Continued
-
The VITROS Immunodiagnostic System uses luminescence as the signal in Device 5. description the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements: -
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone 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) premarket 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 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
- VITROS Progesterone Reagent Pack 6. Device intended For in vitro diagnostic use only. use The VITROS Progesterone Reagent Pack quantitatively measures Progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA or heparin).
Continued on next page
2
510(k) Summary, Continued
The VITROS Immunodiagnostic Products Progesterone Reagent Pack 7. Comparison to predicate (modified) and VITROS Immunodiagnostic Products Progesterone device Calibrators (modified) are substantially equivalent to VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators cleared by the FDA (K972133) for in vitro diagnostic use.
Table 1 lists the assay characteristics performed using the modified VITROS Progesterone assay and the current VITROS Progesterone assay.
Table 1: List of Assay Characteristics: Comparison to Predicate Device
| Device
Characteristic | Predicate Device
VITROS Progesterone assay
(Current) | New Device
VITROS Progesterone assay
(Modified) |
|------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Number of Calibrators | 2 | 3 |
| Nominal Calibrator values | 3.40 and 137 nmol/L | 0.0, 4.25, 120 nmol/L |
| Calibration range | 0 to178 nmol/L | 0 to178 nmol/L |
| Sample type | Serum and plasma (EDTA or
heparin). | Serum and plasma (EDTA or
heparin). |
| Antibody | Rabbit polyclonal anti-
progesterone antibody in
biotinylated antibody reagent | Rabbit polyclonal anti-
progesterone antibody in
biotinylated antibody reagent |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic
System | VITROS Immunodiagnostic
System |
| Sample volume | 25µL | 25µL |
| Incubation time and
temperature | 16 minutes at 37°C with
shaking | 16 minutes at 37°C with
shaking |
Continued on next page
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators
3
510(k) Summary, Continued
The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured reagents along with patient samples with measured Progesterone values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Progesterone assay (modified) for use with human serum and plasma is safe and effective for the stated intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene A. Hanna Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K022901
Trade/Device Name: VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: August 30, 2002 Received: September 3, 2002
Dear Ms. Hanna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/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
6
Statement of Intended Use
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use:
VITROS Immunodiagnostic Products Progesterone Reagent Pack
VITROS Immunodiagnostic Products Progesterone Calibrators
VITROS Progesterone Reagent Pack For in vitro diagnostic use only. The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA or heparin).
Sam Conger
(Division)
Division Laboratory Devices
510(k) Number K022901
(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)