(75 days)
No
The description details a standard indirect fluorescent antibody test and does not mention any AI or ML components. The performance studies are based on comparisons to predicate and reference methods, not on the evaluation of an AI/ML algorithm.
No
The device is an in vitro diagnostic test system used for the detection and semi-quantitation of antibodies in human serum, acting as an aid in diagnosing certain conditions. It does not directly treat or manage a disease.
Yes
The "Intended Use / Indications for Use" states that this is "an in vitro diagnostic test system" and is "to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis." This clearly defines it as a diagnostic device.
No
The device is an in vitro diagnostic test system that uses an indirect fluorescent antibody test. This involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "This is an in vitro diagnostic test system..." and describes its use for detecting antibodies in human serum to aid in the diagnosis of certain conditions.
- Device Description: Describes an "indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum," which is a common type of in vitro diagnostic test.
- Intended User / Care Setting: States "in vitro diagnostic use."
All of these points clearly indicate that the device is intended to be used outside of the body to examine specimens (human serum in this case) for diagnostic purposes.
N/A
Intended Use / Indications for Use
This test system is for in vitro diagnostic use for the detection in antibody in human serum. This test system is to be used as a aid in the sescotated with glomerulonephritis.
This is an in vitro diagnostic test system for thedetection and Semi-quantitation of tagsesses oblic cytoplasmic antibodies in human serum This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.
Product codes
MOB
Device Description
This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum
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)
Serum Samples Obtained from Normal Blood Donors: Serum samples from 497 blood donors (247 males and 250 females) were tested using the subject device and the predicate device.
Comparison table:
| Predicate Device | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 5 | 9 |
| Immuno Concepts ANCA Negative | 37 | 446 |
Reference Method (adjusted for MPO/PR3 ELISA):
| Reference Method | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 5 | 9 |
| Immuno Concepts ANCA Negative | 0 | 483 |
Serum Samples Previously Determined to be Positive for ANCA by Indirect Immunofluorescence: A total of 383 sera were examined.
Comparison table:
| Predicate Device | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 250 | 43+ |
| Immuno Concepts ANCA Negative | 8 | 82 |
Reference Method (adjusted for MPO/PR3 ELISA):
| Reference Method | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 288 | 4 |
| Immuno Concepts ANCA Negative | 5 | 86 |
Reference Method (adjusted for MPO/PR3 ELISA for NOVA Lite™ ANCA):
| Reference Method | Positive | Negative |
|---|---|---|
| NOVA Lite™ ANCA Positive | 254 | 3 |
| NOVA Lite™ ANCA Negative | 39 | 87 |
Combined data from normal blood donors and expected positive samples (initial comparison):
| Predicate Device | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 255 | 52 |
| Immuno Concepts ANCA Negative | 45 | 528 |
Combined data considering MPO and PR-3 testing:
| Reference Method | Positive | Negative |
|---|---|---|
| Immuno Concepts ANCA Positive | 293 | 13 |
| Immuno Concepts ANCA Negative | 5 | 569 |
Reference Method (for NOVA Lite™ ANCA):
| Reference Method | Positive | Negative |
|---|---|---|
| NOVA Lite™ ANCA Positive | 259 | 40 |
| NOVA Lite™ ANCA Negative | 39 | 542 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Initial comparison:
Relative sensitivity : 85%
Relative specificity: 91%
Overall agreement: 89%
After considering MPO and PR-3 testing:
For NOVA Lite™ ANCA:
Relative sensitivity : 86.9%
Relative specificity: 93.1%
Overall agreement: 91.0%
For Immuno Concepts ANCA:
Relative sensitivity : 98.3%
Relative specificity: 97.7%
Overall agreement: 98.0%
Predicate Device(s)
Reference Device(s)
Not Found
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 logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by the letter "I" and a symbol that looks like the number 8. To the right of these symbols is the word "Immuno" in a bold, sans-serif font, stacked on top of the word "concepts" in a similar font.
FEB - 9 1998
Date Prepared: November 24, 1997 Contact Person: Eric S. Hoy, Ph.D. Name of Device:
- Trade Name Immuno Concepts Antineutrophil Cytoplasmic Antibody Test System with Formalin Fixed Human Neutrophils
- · Common Name Immuno Concepts ANCA Test System with Formalin Fixed Human Neutrophils
- · Classification Name Antineutrophil Cytoplasmic Antibody (21 CFR 866.5660)
Legally marketed device with which this device has been shown to be equivalent: NOVA Lite™ ANCA, INOVA Diagnostics, San Diego, CA, K961340
Description:
This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum
Intended Use:
This test system is for in vitro diagnostic use for the detection in antibody in
human serum. This test system is to be used as a aid in the sescotated with glomerulonephritis.
Summary of Technological Characteristics Compared to the Predicate Device: Both the predicate device and this device are fluorescent antibody tests for the detection of antineutrophil cytoplasmic antibody in human serum.
Description of Laboratory Data That Indicate Substantial Equivalence: Serum Samples Obtained from Normal Blood Donors
Serum samples from 497 blood donors (247 males and 250 females) were tested using the subject device and the predicate device. The results of this comparison are shown in the following Table:
| Predicate Device | |||
|---|---|---|---|
| Positive | Negative | ||
| Immuno Concepts ANCA | Positive | 5 | 9 |
| Negative | 37 | 446 |
The relatively high number of ANCA positive samples in these otherwise normal individuals was troubling, so we tested all positive sera for antibodies to MPO and PR3 using ELISA kits obtained from elias usa, inc. Among the IFA positive samples, none were found to be positive for MPO or PR3 antibodies. The samples that were IFA positive on both the predicate device and the subject device were considered true positives for the comparison of the IFA kits. The remaining samples were considered to be false positives on the respective assays. Thus, when the referee method is taken into account, the comparisons look like this:
1
| Reference Method | |||
|---|---|---|---|
| Positive | Negative | ||
| Positive | 5 | 9 | |
| Immuno Concepts ANCA | Negative | 0 | 483 |
Serum Samples Previously Determined to be Positive for ANCA by Indirect Immunofluorescence
Serum samples which had been judged to be positive for ANCA using in-house IFA assays were obtained from reference laboratories in the USA, the United Kingdom, and Australia. A total of 383 sera, which we expected to be positive for ANCA, were examined in this part of the study. These samples were tested on the predicate device and the subject device with the following results:
| Predicate Device | |||
|---|---|---|---|
| Positive | Positive | Negative | |
| Immuno Concepts ANCA | Positive | 250 | 43+ |
| Negative | 8 | 82 |
The discrepant samples were tested for MPO and PR3 antibodies by ELISA. When this referee method was taken into account, the comparisons showed the following data:
| Reference Method | ||
|---|---|---|
| Positive | Negative | |
| Immuno Concepts ANCA | 288 | 4 |
| 5 | 86 | |
| Reference Method | ||
| Positive | Negative | |
| NOVA Lite™ ANCA | 254 | 3 |
| 39 | 87 |
Combining the data from the normal blood donor population and the expected positive samples, we obtained the following data on the initial comparison of the subject device and the predicate device:
| Predicate Device | |||
|---|---|---|---|
| Positive | Negative | ||
| Immuno Concepts ANCA | Positive | 255 | 52 |
| Immuno Concepts ANCA | Negative | 45 | 528 |
Relative sensitivity : 85% Relative specificity: 91% Overall agreement: 89%
2
Taking into account the results of the specific MPO and PR-3 testing, the two tests yield the following data:
| Reference Method | |||
|---|---|---|---|
| Positive | Negative | ||
| Immuno Concepts ANCA | Positive | 293 | 13 |
| Negative | 5 | 569 | |
| Reference Method | |||
| Positive | Negative | ||
| NOVA Lite™ ANCA | Positive | 259 | 40 |
| Negative | 39 | 542 |
For NOVA Lite™ ANCA: For Immuno Concepts ANCA: Relative sensitivity : 86.9% Relative sensitivity : 98.3% Relative specificity: 93.1% Relative specificity: 97.7% Overall agreement: 91.0% Overall agreement: 98.0%
In accordance with 21 CFR 807.92(b)(3), we conclude from these data that the present device is substantially equivalent to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion on the left. The eagle symbol is composed of three curved lines that resemble the wings and body of an eagle. The text is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eric S. Hoy, Ph.D. Chief Scientific Officer Immuno Concepts Incorporated 9779 "I" Business Park Drive Sacramento, California 95827
FEB - 9 1998
Re : K974463 Immuno Concepts ANCA Test System with Formalin Trade Name: Fixed Human Neutrophils Regulatory Class: II Product Code: мов Dated: November 24, 1997 November 26, 1997 Received:
Dear Dr. Hoy:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS)-for Medical Devices: "General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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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Page 2
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.
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" (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 Sutman
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
5
Page of
510(k) Number (if known): K974463
Device Name: Immuno Concepts ANCA Test System with Formalin Fixed Human Neutrophils
Indications For Use:
This is an in vitro diagnostic test system for thedetection and Semi-quantitation of tagsesses oblic cytoplasmic antibodies in human serum This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number ___________
| Prescription Use | ✓ | OR | Over-The-Counter Use ___________ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |