CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM

K112550 · Sebia · GKA · May 25, 2012 · Hematology

Device Facts

• Record ID: K112550
• Device Name: CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
• Applicant: Sebia
• Product Code: GKA · Hematology
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7415
• Device Class: Class 2

Intended 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) the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS with HEMOGLOBIN(E) kit is designed for laboratory use. The CAPILLARYS 2 FLEX-PIERCING 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 whole blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. For In Vitro Diagnostic Use.

Device Story

Device is an automated capillary electrophoresis system for hemoglobin analysis. Input: whole blood samples in K2EDTA or K3EDTA tubes. Process: automated hemolysate preparation followed by capillary electrophoresis in alkaline buffer (pH 9.4). Output: quantitative hemoglobin profile (fractions A, A2, F) and detection of variants (S, C, E, D). Used in clinical laboratories by trained personnel. Results provided to clinicians for hemoglobinopathy assessment and patient management.

Clinical Evidence

Bench testing only. Analytical performance evaluated through comparison studies between the CAPILLARYS 2 FLEX-PIERCING and the predicate CAPILLARYS 2 system. Studies confirmed equivalent separation and quantification of hemoglobin fractions A, A2, and F, and detection of variants S, C, E, and D. No clinical diagnostic trials required for this analytical performance validation.

Technological Characteristics

Capillary electrophoresis system; alkaline buffer (pH 9.4); automated sampling via FLEX-PIERCING mechanism; K2EDTA/K3EDTA whole blood input; quantitative analysis of hemoglobin fractions; standalone laboratory instrument.

Indications for Use

Indicated for laboratory use for the separation and quantitative analysis of normal hemoglobins (A, A2, F) and detection of major hemoglobin variants (S, C, E, D) in human whole blood samples (K2EDTA or K3EDTA anticoagulated).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sebia CAPILLARYS HEMOGLOBIN(E) (K080327)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Sebia Inc. c/o Ms. Karen Anderson Director of Technical and Quality Assurance 1705 Corporate Drive Suite 400 Norcoss, GA. 30093

MAY 2 5 2012

Re: k112550

Trade/Device Name: Sebia CAPILLARYS HEMOGLOBINE(E) using the CAPILLARYS 2 FLEX-PIERCING 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 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 – Ms. Karen Anderson

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 [phone]. 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.

ದಿಂದ

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

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): K112250

## Device Name: CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 FLEX-PIERCING 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) the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS with HEMOGLOBIN(E) kit is designed for laboratory use.

The CAPILLARYS 2 FLEX-PIERCING 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 whole blood samples collected in tubes containing K₂EDTA or K3EDTA as anticoagulant.

For In Vitro Diagnostic Use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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510(k) K112250