(269 days)
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No
The description focuses on the analytical method (capillary electrophoresis) and the automation of the process, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as an "In Vitro Diagnostic Use" device designed for laboratory use to analyze hemoglobin in blood samples, which indicates it is for diagnostic purposes, not for treating a disease or condition.
Yes
The document states "For In Vitro Diagnostic Use" under the "Intended Use / Indications for Use" section. This directly indicates the device's diagnostic purpose.
No
The device description explicitly states it is an "automated analyzer" and performs assays on blood samples, indicating it is a hardware instrument with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
- Nature of the Test: The device is designed to analyze human blood samples to detect and quantify different types of hemoglobin. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is for the separation and detection of hemoglobins in human blood samples, which is a diagnostic purpose.
- Care Setting: The device is designed for "laboratory use," which is a typical setting for IVD devices.
N/A
Intended Use / Indications for Use
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use.
The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant.
For In Vitro Diagnostic Use.
Product codes
GKA
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
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
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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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§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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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 stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top and left side of the seal.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Sebia Inc.
c/o Ms. Karen Anderson, MT(ASCP) Director of Technical and Quality Assurance 1705 Corporate Drive, Suite 400 Norcross, Georgia 30093
MAY 2 4 2012
Re: K112491
Trade/Device Name: Sebia CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument
Regulation Number: 21 CFR § 864.7415 Regulation Name: Abnormal hemoglobin assay Regulatory Class: Class II Product Code: GKA Dated: May 11, 2012 Received: May 14, 2012
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 I ou mayy more of the Act include requirements for annual registration, listing of general controls provision 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 if your device is thatsinist major regulations affecting your device can be found in Title 21, additional 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 that I DA has Intact a wond regulations administered by other Federal agencies. You must of any I cacial saltutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rice of requirements, 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 - Ms. Karen Anderson
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as be form inrketing your device as described in your Section 510(k) premarket while won to began mading of substantial equivalence of your device to a legally marketed nothicate 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 11 you dente opened 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
04 Maria M. 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): K112491
Device Name: CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument
Indications For Use:
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use.
The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.
For In Vitro Diagnostic Use.
Prescription Use
(Part 21 CFR 801 Subpart D)
510lk
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 and Safety
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