(294 days)
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No
The summary describes a standard electrophoresis test and instrument for identifying proteins. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an "in vitro diagnostic" test for identifying suspected monoclonal proteins, which aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the qualitative in vitro diagnostic separation and identification of immunoglobulins" and "is useful as an aid in identifying suspected monoclonal proteins." The phrase "in vitro diagnostic" directly indicates its diagnostic purpose.
No
The description explicitly states the device is an "in vitro diagnostic separation and identification of immunoglobulins... using agarose gel supported on Mylar®" and is intended to be used with the "automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device." This indicates the device is a physical kit and analyzer system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "for the qualitative in vitro diagnostic separation and identification of immunoglobulins..."
- "The test is useful as an aid in identifying suspected monoclonal proteins."
- "The test result is to be used in conjunction with clinical and other laboratory findings."
These phrases clearly indicate that the device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of a medical condition (identifying suspected monoclonal proteins).
N/A
Intended Use / Indications for Use
The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.
The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.
Product codes
CFF, DFH, DEH, CEF
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Grifols USA, LLC Diagnostic Division c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
OCT 13 2011
Re: K103757
Trade/Device Name: Immunofixation Electrophoresis Test using Interlab G26 Instrument Regulation Number: 21 CFR $866.5510
Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test System Regulatory Class: Class II
Product Code: CFF, DFH, DEH, CEF
- Dated: October 7, 2011
Received: October 11, 2011
Dear Mr. Lehnus:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Mr. Gary Lehnus
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Reena Philip
on Maria Chan, 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
2
Indications for Use
510(k) Number (if known):
Device Name: Immunofixation Electrophoresis Test using Interlab G 26 Instrument
Indications For Use:
The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.
The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.
Prescription Use X (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation a
510K K103757
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