(132 days)
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No
The summary describes a semiquantitative enzyme linked immunoassay, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is described as a semiquantitative enzyme linked immunoassay for detecting autoantibodies, used as an aid in diagnosis. This indicates a diagnostic purpose rather than a therapeutic one.
Yes
The intended use explicitly states the device is "for use as an aid in the diagnosis" of certain medical conditions.
No
The provided 510(k) summary describes an enzyme-linked immunoassay, which is a laboratory test involving physical reagents and processes, not a software-only device. The lack of information in other sections further supports this conclusion.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "semiquantitative enzyme linked immunoasay for detecting IgG class autoantibody to βρ glycoprotein I (β GPT)". This describes a test performed in vitro (outside the body) on a biological sample (likely blood or serum) to detect a specific substance (autoantibody).
- Purpose: The purpose is "for use as an aid in the diagnosis of of certain arcommand assessment lupus erythematosus disorders, such as those secondary to systemic lupus erythematosus disorders, Baon ake thrombotic diseases." This clearly indicates the test is used to provide information for diagnostic purposes.
The core definition of an IVD is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
A semiquantitative enzyme linked immunoasay for detecting IgG entification of the commends of (8, GRI) for use as an aid class autoantibody to βρ glycoprotein I (β GPT) for use as an aid class autoantibody to βρ glycoprotein I (β GPT) for use as an aid oantibody to β2 glycoprocein i (pp ord) assess thrombotic the in the diagnosis of of certain arcommand assessment lupus erythematosus disorders, such as those secondary to systemic lupus erythematosus disorders, Baon ake thrombotic diseases.
Product codes
MSV
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Brys Myers INOVA Diagnostics, Inc. 10451 Roselle Street San Diego, CA 92121 ---
Re: K970551/S001 Trade Name: QUANTA Lite™ Beta 2 GPI IgG ELISA Regulatory Class: II Product Code: MSV Dated: May 02, 1997 Received: May 05, 1997
Dear Mr. Myers:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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Page 2
This letter will allow you to begin marketing your device as described in your 5!0(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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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 | "
011 |
| ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
K970551 510(k) Number (if known):
QUANTA Lite™ B,GPI IgG Device Name:
Indications For Use:
A semiquantitative enzyme linked immunoasay for detecting IgG
entification of the commends of (8, GRI) for use as an aid class autoantibody to βρ glycoprotein I (β GPT) for use as an aid
class autoantibody to βρ glycoprotein I (β GPT) for use as an aid oantibody to β2 glycoprocein i (pp ord) assess thrombotic the in the diagnosis of of certain arcommand assessment lupus erythematosus
disorders, such as those secondary to systemic lupus erythematosus disorders, Baon ake thrombotic diseases.
Peter E. Mapin
Division of Clinical I 510(k) Nur
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEGERD)
Concurrence of CDRB, Office of Device Evaluation (ODE)
Image /page/2/Picture/9 description: The image shows the words "Prescription Use" in bold font, with an underscore after the word "Use". Below this, in a smaller font, is the text "(Per 21 CFR 801.109)". There is a check mark above the underscore after the word "Use".
Over-The-Counter Use
(Optional Format 1-2-96)