(345 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses on an in-vitro diagnostic assay.
No
The device is intended for in-vitro diagnostic measurement of autoantibodies, which is used to aid in the diagnosis of thrombosis. It does not directly treat or cure thrombosis.
Yes
The "Intended Use / Indications for Use" states that the kit "may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis." Aid in diagnosis is a key characteristic of a diagnostic device.
No
The intended use describes an in-vitro diagnostic kit for measuring antibodies in human serum, which inherently involves physical reagents and laboratory procedures, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "in-vitro measurement" of a substance (IgA autoantibodies against B2-glycoprotein 1) present in a human sample (serum). This is the defining characteristic of an in vitro diagnostic device – it's used to examine samples taken from the body, rather than being used directly on or in the body.
The rest of the information provided (Device Description, Mentions image processing, etc.) being "Not Found" or "Not Applicable" doesn't negate the clear statement in the Intended Use that it's for in-vitro measurement.
N/A
Intended Use / Indications for Use
For the in-vitro measurement of IgA autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
Product codes
MSV
Device Description
Not Found
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): 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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three wavy lines above three smaller wavy lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 5 2000
The Binding Site c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K991802 Trade Name: Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Regulatory Class: II Product Code: MSV Dated: March 31, 2000 Received: April 4, 2000
Dear Mr. Geller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 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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Page_ |of
510(k) Number (if known): _ | 99 / 807-
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
INDICATIONS FOR USE STATEMENT
Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Device Name:
for ' Use: For the in-vitro measurement of IgA Indications autoantibodies against B2-glycoprotein 1 (B2GP1) present in human This kit may be used in conjunction with anticardiolipin serum. assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tute E. Maleni
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991802
Prescription Use √
(Per 21 CFR 801.109)
OR
一,
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)