(18 days)
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No
The summary describes a reagent pack and calibrators for a laboratory immunoassay system, which are chemical components and do not inherently incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods typically associated with AI/ML.
No
This device is an in vitro diagnostic (IVD) reagent pack and calibrator used for the quantitative measurement of progesterone, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
The device is described as being for "diagnosis and treatment of disorders of the ovaries or placenta," which clearly indicates a diagnostic purpose.
No
The 510(k) summary describes a reagent pack and calibrators for an in vitro diagnostic system, which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the in vitro quantitative measurement of progesterone in human serum and plasma..."
- "For in vitro use in the calibration of the VITROS Immunodiagnostic System..."
The phrase "in vitro" is a key indicator that the device is intended for use outside of the living body, which is the definition of an in vitro diagnostic device. The purpose of measuring progesterone in human serum and plasma for diagnosis and treatment of disorders further confirms its IVD nature.
N/A
Intended Use / Indications for Use
VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta
Product codes
JLS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Ann M. Quinn · Manager, Regulatory Affairs Johnson & Johnson Clinical Diagnostics 100 Indiqo Creek Rochester, New York 14650
Re : K972133 VITROS Immunodiagnostic Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070) Regulatory Class: I Product Code: JLS Dated: June 5, 1997 Received: June 6, 1997
Dear Ms. Quinn:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Reqister. 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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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/dsmamain.html".
Sincerely yours,
Steven Litman
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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Statement of Intended Use (Appendix D)
510(k) Number (if known): VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators Indications for Use: VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER ITAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 10(k) Number | K972133 |
|---|---|
| -------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| ------------------ | -------------- |
OR Over-The-Counter Use ______
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Progesterone Reagent Pack
(Per 21 CFR 801.109) VITROS Immunodiagnostic Products Progesterone Calibrators92
510(k) Number (if known
Device Name:
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