(43 days)
No
The summary describes a standard enzyme immunoassay test and does not mention any AI or ML components.
No
The device is an in vitro diagnostic test system used for the detection of antibodies as an aid in diagnosis, not for treating or preventing disease.
Yes
The device is described as an "enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum" and is "to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides." This clearly indicates its purpose is to provide information for medical diagnosis.
No
The device description explicitly states it is an "enzyme immunoassay test system" and an "enzyme immunoassay," which are laboratory tests involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "test system for the detection of antibodies to myeloperoxidase (MPO) in human serum." This involves testing a biological sample (human serum) outside of the body to provide information about a person's health status (presence of antibodies associated with certain conditions).
- Device Description: The description confirms it's an "enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum." This further reinforces that it's a test performed on a biological sample.
- Performance Studies: The description of the performance studies details testing on human serum samples from various patient populations and blood donors. This is characteristic of studies conducted for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a predicate device (K981030; Bindazyme™ Anti-MPO Enzyme Immunoassay Kit) which is also an enzyme immunoassay for detecting MPO antibodies, strongly suggests that the subject device falls under the same regulatory category, which is IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.
Product codes
MOB
Device Description
This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.
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
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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
The Immuno Concepts RELISA® MPO Test System was compared to the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK. (K981030). The population studied consisted of 208 samples which were submitted to clinical laboratories for ANCA, MPO and PR3 testing, but without specific diagnoses, 7 samples which were from pateints with a diagnosis of Churg-Strauss syndrome, 18 patients with a diagnosis of vasculitis, 25 patients with a diagnosis of Wegener's granulomatosis, 261 All samples from male blood donors, and 239 samples from female blood donors. samples were tested in parallel on the predicate device and the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The population studied consisted of 208 samples which were submitted to clinical laboratories for ANCA, MPO and PR3 testing, but without specific diagnoses, 7 samples which were from pateints with a diagnosis of Churg-Strauss syndrome, 18 patients with a diagnosis of vasculitis, 25 patients with a diagnosis of Wegener's granulomatosis, 261 All samples from male blood donors, and 239 samples from female blood donors. samples were tested in parallel on the predicate device and the subject device. Based on this comparison, the following data were obtained:
Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Negative; Immuno Concepts RELISA® MPO-ANCA Test System Positive: 53
Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Positive; Immuno Concepts RELISA® MPO-ANCA Test System Positive: 38
Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Negative; Immuno Concepts RELISA® MPO-ANCA Test System Negative: 2
Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Positive; Immuno Concepts RELISA® MPO-ANCA Test System Negative: 665
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative sensitivity, 96.4%; relative specificity, 94.6%; and overall agreement, 94.7%
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/0 description: The image shows the logo for Immuno Concepts. The logo is black and white and features a stylized "IC" with the words "Immuno" and "Concepts" stacked on top of each other. The "I" in "IC" is represented by two horizontal lines, and the "C" is represented by a circle with three smaller circles inside.
NOV 1 4 2001
Date Prepared: July 23, 2001 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device:
- · Trade Name RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase
- · Common Name Anti-MPO Antibody Enzyme Immunoassay Test Kit
- · Classification Name · Test System, Antineutrophil Cytoplasmic Antibodies (ANCA) (21 CFR 866.5660)
Legally marketed device with which this device has been shown to be equivalent: Bindazyme™ Anti-MPO Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK, K981030.
Description:
This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.
Intended Use:
This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.
Summary of Technological Characteristics Compared to the Predicate Device:
Technologically, this device is similar to the predicate device with the following exceptions:
a) The predicate device has all 96 microwells sealed in a single pouch. The present device has each eight well strip of microwells sealed in an individual pouch, so that unused wells remain in the pouches, and maintain at least 12 months stability.
b) The predicate device uses six calibrator sera, the present device uses five calibrator sera.
Description of Laboratory Data That Indicate Substantial Equivalence:
The Immuno Concepts RELISA® MPO Test System was compared to the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK. (K981030). The population studied consisted of 208 samples which were submitted to clinical laboratories for ANCA, MPO and PR3 testing, but without specific diagnoses, 7 samples which were from pateints with a diagnosis of Churg-Strauss syndrome, 18 patients with a diagnosis of vasculitis, 25 patients with a diagnosis of Wegener's granulomatosis, 261 All samples from male blood donors, and 239 samples from female blood donors. samples were tested in parallel on the predicate device and the subject device. Based on this comparison, the following data were obtained:
1
Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Negative Positive
| Immuno Concepts | Positive | 53 | 38 |
|---|---|---|---|
| RELISA® MPO-ANCA | |||
| Test System | Negative | 2 | 665 |
These data yield the following statistics: relative sensitivity, 96.4%; relative specificity, 94.6%; and overall agreement, 94.7%
Among the 38 "false positive" samples, 28 showed a P-ANCA pattern by Among the 56 Traise postere banged, by immunofluorescence, 3 showed immanoridorescence, 3 Biowed a Chilon parceace, and 4 did not demonstrate any immunofluorescent pattern.
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.
2
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eric Hoy, Ph.D., SI (ASCP) NOV 1 4 2001 Chief Scientific Officer, Regulatory Affairs Immuno Concepts, Inc. 2280 Springlake Road, Suite 106 Dallas, Texas 75234
Re: K013285
Trade/Device Name: Immuno Concepts RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase Regulation Number: 21 CFR § 866.5660 Regulation Name: ANCA Test System Regulatory Class: II Product Code: MOB Dated: September 27, 2001 Received: October 2, 2001
Dear Dr. Hoy:
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 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 Autman
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
4
NOV 1 4 2001
Page 1 of 1
510(k) number (if known):
Device Name: RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase
Indications for use:
This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.
Sousan Saltaie
510(k) Numb
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________