(297 days)
Not Found
No
The document describes an automated analyzer for hemoglobin analysis using electrophoresis, with no mention of AI or ML technologies.
No.
The device is used for in-vitro diagnostic analysis of hemoglobin variants in newborns, which is a diagnostic purpose, not a therapeutic one.
Yes
The text explicitly states "For In Vitro Diagnostic Use" for both the kit and the control, and describes the CAPILLARYS 2 as performing a "qualitative analysis of hemoglobins," which are diagnostic procedures.
No
The device description explicitly states it is an "automated analyzer" which performs a physical assay on blood samples. This indicates it is a hardware device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use" multiple times for both the CAPILLARYS NEONAT Hb kit and the Hb AF Control.
- Intended Use: The intended use describes the device as being used to separate and analyze hemoglobins in blood samples from human newborns. This is a diagnostic test performed on a biological sample outside of the body.
- Laboratory Use: The device is designed for "laboratory use," which is a common setting for IVD testing.
- Qualitative Analysis: The CAPILLARYS 2 performs "qualitative analysis of hemoglobins," which is a type of diagnostic information.
- Control Material: The Hb AF Control is described as a "quality control" for the procedure, which is a standard component of IVD testing to ensure accuracy and reliability.
All of these factors clearly indicate that this device is intended for use in the diagnosis of conditions by examining samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CAPILLARYS NEONAT Hb kit is designed for the separation of the normal hemoglobins (F and A) in blood samples from human new-borns, and for the major hemoglobin vanants (S, C, E, D and Bart's), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use.
The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.
For In Vitro Diagnostic Use.
The Hb AF Control is designed:
-
for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresis procedure used with the CAPILLARYS 2 system, and,
-
for the quantitative quality control for detection of the human hemoglobins A, F and A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system.
The Hb AF Control is designed for laboratory use. It should be used (with its bar code label for the CAPILLARYS and MINICAP procedures) like a normal human blood. The values obtained must fall within the range provided with each batch of Hb AF Control.
For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
GKA
Device Description
The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.
The Hb AF Control is designed for laboratory use. It should be used (with its bar code label for the CAPILLARYS and MINICAP procedures) like a normal human blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
human new-borns
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
FEB 2 2 2010
Sebia c/o Ms. Karen Anderson, MT(ASCP) Director of Technical Training and Regulatory 1705 Corporate Drive, Suite 400 Norcross, Georgia 30093
Re: K091283
Trade/Device Name: CAPILLARYS NEONAT Hb, PN 2006 Hb AF CONTROL, PN 4777 Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal hemoglobin assay Regulatory Class: Class II Product Code: GKA Dated: February 5, 2010 Received: February 12, 2010
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
1
Page 2 - Ms. Karen Anderson
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 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 (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.
for 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): K091283
Device Name: CAPILLARYS NEONAT Hb, PN 2006
Indications For Use:
The CAPILLARYS NEONAT Hb kit is designed for the separation of the normal hemoglobins (F and A) in blood samples from human new-borns, and for the major hemoglobin vanants (S, C, E, D and Bart's), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use.
The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.
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
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091283
3
Indications for Use
510(k) Number (if known):
Device Name: Hb AF CONTROL, PN 4777
Indications For Use:
The Hb AF Control is designed:
-
for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresis procedure used with the CAPILLARYS 2 system, and,
-
for the quantitative quality control for detection of the human hemoglobins A, F and A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system.
The Hb AF Control is designed for laboratory use. It should be used (with its bar code label for the CAPILLARYS and MINICAP procedures) like a normal human blood. The values obtained must fall within the range provided with each batch of Hb AF Control.
For In Vitro Diagnostic Use.
Prescription Use (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 Diagnostic (){aluation and Safer
51000 K091283
Page 1 of 1
Image /page/3/Picture/18 description: The image is a black and white circular graphic. The number 3502 is prominently displayed in the center of the circle. The background of the circle is filled with a dense, speckled pattern, creating a textured effect.