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.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Sebia CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument." However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.

The document mainly focuses on:

The FDA's decision of substantial equivalence.
The regulatory classification (Class II, Product Code GKA).
General information about FDA regulations for medical devices.
The intended use of the device.

Therefore, I cannot provide the specific details about acceptance criteria, performance, sample sizes, ground truth establishment, or expert qualifications as these are not present in the given text.

To answer your request, I would need a different document, typically a Summary of Safety and Effectiveness or a full clinical study report, which is usually part of the 510(k) submission but not contained within this FDA correspondence letter.

Summary

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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

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Indications for Use

510(k) Number (if known): K112491

Device Name: CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument

Indications For Use:

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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Regulation Number and Section

§ 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.