(73 days)
Not Found
No
The summary describes a control material for in vitro diagnostic assays, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, image processing, or data analysis algorithms.
No.
The device is for in vitro diagnostic use to monitor the precision and accuracy of assays, not for treating a condition or disease.
Yes
The 'Intended Use / Indications for Use' states "For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems." This indicates it is used in a diagnostic process, even if it's for quality control of other diagnostic assays.
No
The device description explicitly states it is a "bovine serum based" control material, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use..." This is the primary indicator that the device is intended for use outside of a living organism to examine specimens from the human body for diagnostic purposes.
Furthermore, the device is described as a control material used to monitor the precision and accuracy of assays that measure complexed PSA, which is a substance found in human blood. This aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added.
The analytes currently in the control material are: cPSA
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.
Not Found
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
JUL - 6 2006
Summary of Safety and Effectiveness
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.
k 061137 The assigned 510(k) Number is:
Submitter's Name and Address
Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235
Contact Person: Andres Holle Telephone: 914-524-3494 Fax: 914-524-2500 e-mail: andres.holle.b(@bayer.com
Contract Manufacturer
Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645-0307 Establishment Registration: 1181121
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ADVIA® IMS cPSA Control ADVIA® IMS cPSA Control Assayed Quality Control Material Assayed Quality Control Material Class I 21 CFR 862.1660 Chemistry (75) JJY
1
Predicate Device:
Bayer Special Chemistry Controls Premarket Notification Number: K033379
Device Description:
The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added.
The analytes currently in the control material are: cPSA
Intended Use:
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.
Substantial Equivalence:
The ADVIA® IMS cPSA Controls are substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use as the previously cleared Bayer Special Chemistry Controls.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" written around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 6 2006
Bayer Healthcare, LLC c/o Mr. Andres Holle Manager, Regulatory Affairs 511 Benedict Ave. Tarrytown, NY 10591-5097
Re: K061137
Trade/Device Name: ADVIA® IMS cPSA Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: April 17, 2006 Received: April 25, 2006
Dear Mr. Holle:
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 cnactment 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 affècting 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 FDAs 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 Acts requirements. including, but not limited to: registration and listing (21 CER 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.
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This letter will allow you to begin marketing your device as described in your Section 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 wour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation ventitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (
Sincerely yours.
Robert R. Bochel
Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ADVIA® IMS cPSA Control
Indications for Use:
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immunol® systems.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Mana In Chan
Division Sign-Off
Office of In Vitto Diagnostic Device Evaluation and Safety
510(k) K061137