(231 days)
Not Found
Not Found
No
The description focuses on automated electrophoresis and analysis of hemoglobin profiles, with no mention of AI or ML terms or concepts.
No
The device is an in vitro diagnostic (IVD) kit used for the analysis of hemoglobins to separate and detect variants, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use," indicating its purpose is for diagnosing medical conditions.
No
The device description clearly states it is a "kit" and describes a process involving electrophoresis and red blood cells, indicating it includes physical components and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states: "For In Vitro Diagnostic Use" in the "Intended Use / Indications for Use" section. This is the primary indicator that the device is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
N/A
Intended Use / Indications for Use
The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System.
The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.
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
Not Found
Intended User / Care Setting
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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): 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.
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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).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sebia Inc Karen Anderson Director of Technical Training and Regulatory 400-1705 Corporate Drive Suite 400 Norcross, Georgia 30093
MAR 2 G 2009
Re: K082227 Trade/Device Name: Minicap Hemoglobin (E) Kit, Model 2207, 2227 Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal Hemoglobin Assay Regulatory Class: II Product Code: GKA Dated: March 12, 2009 Received: March 13, 2009
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2- Ms. Anderson
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 meall that I DA has made a december and regulations administered by other requirements of the Act of any I edelized and a matter requirements, including, but not Federal agencies: You must comply manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practice requirements and extronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will anow you to begin manaling of substantial equivalence of your device 510(K) prematker notification: "He I Presults 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 the labeling regulation, please ontact the If you desire specific acvice in your Evaluation and Safety at 240- 276-0450. Also, Office of in Vitro Diagnostic Dovies Evaranding by reference to premarket notification" (21 CFR Part 807.97). For question regarding postmarket surveillance, please contact (21 CFR Furt 601.91). Por questand Biometric's (OSB's) Division of Postmarket CDRIT's Office of Surveillance and Distinct reporting of device adverse Surveillance at 246-270 91111118 (MDR), please contact the Division of Surveillance Systems at 240-276-3464. You many obtain other general information on your Systems at 240-270-5404. Tourmaly Jouxil on of Small Manufactuers, International and Its polisionines under the Free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Josephine Bautista
for Maria M. Chan, Ph.D.
Prector 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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MINICAP HEMOGLOBIN(E)
Page 1 of 1
510(K) Number (if known):
Device name:
MINICAP HEMOGLOBIN(E), PN 2207 & PN 2227
Indications For Use:
The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System.
The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.
For In Vitro Diagnostic Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _
(Optional Format 1-2-96)
Suphine Bautida
Division Sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082227
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