(308 days)
Not Found
None
No
The description focuses on automated procedural sequences and direct detection based on absorbance, with visual evaluation of electrophoregrams. There is no mention of AI, ML, or related concepts.
No
The device is described as an "in vitro diagnostic use" kit for detecting and characterizing hemoglobins in human blood, which is for diagnostic purposes, not therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the kit is designed for "detection and the characterization of hemoglobins in human blood," and "For in vitro diagnostic use," which are clear indicators of a diagnostic device.
No
The device description explicitly mentions a "Sebia CAPILLARYS system" which performs automated procedural sequences, mixes blood samples, and uses silica capillaries and absorbance detection. This indicates the device includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"For in vitro diagnostic use"
This statement, along with the description of the device being used to detect and characterize hemoglobins in human blood, confirms its classification as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The electrophoregrams are evaluated visually for the pattern abnormalities. Direct detection of the hemoglobins provides relative quantification of individual hemoglobin fraction of the normal hemoglobin fractions A, A2, F and for the detection of major hemoglobin variants as S, C, E and D using Capillarys electrophoresis
For in vitro diagnostic use
Product codes
GKA
Device Description
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The electrophoregrams are evaluated visually for the pattern abnormalities. Direct detection of the hemoglobins provides relative quantification of individual hemoglobin fraction of the normal hemoglobin fractions A, A2, F and for the detection of major hemoglobin variants as S, C, E and D using Capillarys electrophoresis
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a circular seal with a stylized eagle in the center. The eagle is depicted with its wings spread and its head turned to the right. The seal is surrounded by text, but the text is too small to read. The seal is likely a government or organizational seal.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen Anderson, MT (ASCP) Director of Customer Support Sebia, Inc. 400-1705 Corporate Drive Norcross, Georgia 30093
Re: K052291
Trade/Device Name: Capillarys Hemoglobin (E), PN 2007 Regulation Number: 21 CFR & 864.7515 Regulation Name: Abnormal Hemoglobin Assay Regulatory Class: II Product Code: GKA Dated: May 15, 2006 Received: May 17, 2006
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.
JUN 2 7 2006
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 frea number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, P/ Director Division of Immunology and Hematology 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): ___K052991
Device Name: CAPILLARYS HEMOGLOBIN(E), PN 2007
Indications for Use:
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The electrophoregrams are evaluated visually for the pattern abnormalities. Direct detection of the hemoglobins provides relative quantification of individual hemoglobin fraction of the normal hemoglobin fractions A, A2, F and for the detection of major hemoglobin variants as S, C, E and D using Capillarys electrophoresis
For in vitro diagnostic use
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Lawrence Ostrick, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Viten Diaunostic Device Evaluation and sticty
510(k) K052291