(493 days)
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Not Found
No
The summary describes a quality control material for electrophoresis methods, with no mention of AI or ML.
No
The device is a quality control solution for in vitro diagnostic testing, not a device used to treat or prevent disease in a patient.
Yes
The device is described as "IT / IF Control" which is designed for "qualitative quality control of the detection and characterization of human monoclonal immunoglobulins" using electrophoresis methods. It is intended for "In Vitro Diagnostic Use" and is used in a laboratory setting "like a human serum sample." This indicates its role in ensuring the accuracy and reliability of diagnostic tests, making it a component of the diagnostic process.
No
The device description and intended use clearly describe a physical control material (IT / IF Control) used in laboratory electrophoresis methods. It is treated like a human serum sample and has a barcode label for use with specific instruments. This indicates a physical, non-software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The IT / IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins..."
- "For In Vitro Diagnostic Use."
These statements clearly indicate that the device is intended for use in vitro (outside the body) for diagnostic purposes (quality control of tests used for detection and characterization of substances in human samples).
N/A
Intended Use / Indications for Use
The IT / IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kaopa and Lambda) with the electrophoresis methods:
- Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, -HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For In Vitro Diagnostic Use.
Prescription Use X (Part 21 CFR 801 Subpart D)
Product codes
JJY, 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory use
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized emblem that resembles a bird or a symbol representing human profiles. The emblem is abstract and composed of curved lines.
10903 New Hampshire Avenue Silver Spring, MD 20993
Sebia Inc. USA c/o Ms. Karen Anderson, MT (ASCP) Director of Technical and Quality Assurance 1705 Corporate Drive, Suite 400 Norcross, GA 30093
NOV - 7 2011
Re: K101863
Trade/Device Name: IT/IF Control Regulation Number: 21 CFR §862.1660 Regulation Name: Ouality Control Material (Assayed and Unassayed) Regulatory Class: Class I (Reserved) Product Codes: JJY, CFF, DFH, DEH, CEF Dated: October 12, 2011 Received: October 13, 2011
Dear Ms. Anderson:
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. Iisting 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 - Ms. Karen Anderson
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 yours.
Reena Philip
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
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Indications for Use
510(k) Number (if known): _ K101863
Device Name: IT / IF CONTROL
Indications For Use:
The IT / IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kaopa and Lambda) with the electrophoresis methods:
- Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, -HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For In Vitro Diagnostic Use.
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 Diagnost Device Evaluation and
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510K K101863