(75 days)
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No
The summary describes a reagent kit for a turbidimetric analyzer, which is a standard laboratory technique. There is no mention of AI, ML, or any related concepts.
No.
The device is described as a "Human IgG Subclass Liquid Reagent Kit" intended for the "quantification of IgG subclasses in serum" which aids in diagnosis. It does not provide any therapeutic intervention or treatment.
Yes
The "Intended Use / Indications for Use" section states: "Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This explicitly indicates a diagnostic purpose.
No
The device is described as a "Human IgG Subclass Liguid Reagent Kit" and is intended for use on a "Hitachi 911/7070 Turbidimetric Analyzer." This clearly indicates it is a physical reagent kit and relies on a hardware analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "quantification of IgG subclasses in serum" and that this measurement "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes.
- Device Description: The description mentions it's a "Liquid Reagent Kit" for use on a "Turbidimetric Analyzer." This aligns with the typical components and methods used in in vitro diagnostic testing.
The definition of an IVD generally includes reagents, instruments, and systems 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. This device fits that description.
N/A
Intended Use / Indications for Use
This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
DEZ
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
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 7 2002
The Binding Site, Limited c/o Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, CA 90404
Re: K021081
Device Name: Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E Immunological Test System Regulatory Class: II Product Code: DEZ Dated: May 28, 2002 Received: June 4, 2002
Dear Mr. Geller:
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 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 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.
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K021081 INDICATIONS FOR USE STATEMENT
Device Name: Human IgG Subclass Liquid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyser
Indications for Use: This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Sousan S. Altaie
(Division Sign-Off) Division of Clinical Labo 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_