(43 days)
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.
This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.
Here's an analysis of the provided information regarding the Immuno Concepts RELISA® MPO-ANCA Test System:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the FDA's "substantial equivalence" determination, meaning the new device's performance should be comparable to the legally marketed predicate device. While explicit numerical acceptance criteria aren't listed, the study demonstrates performance relative to the predicate device.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Immuno Concepts RELISA® MPO) |
|---|---|---|
| Relative Sensitivity | Comparable to Predicate Device | 96.4% |
| Relative Specificity | Comparable to Predicate Device | 94.6% |
| Overall Agreement | Comparable to Predicate Device | 94.7% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 818 samples were used for the test set. Breakdown:
- 208 samples submitted to clinical laboratories for ANCA, MPO, and PR3 testing (without specific diagnoses).
- 7 samples from patients with a diagnosis of Churg-Strauss syndrome.
- 18 patients with a diagnosis of vasculitis.
- 25 patients with a diagnosis of Wegener's granulomatosis.
- 261 samples from male blood donors.
- 239 samples from female blood donors.
- Data Provenance: The document does not explicitly state the country of origin for all samples. However, the predicate device is manufactured in Birmingham, England, UK. The source of the 208 clinical samples is general ("clinical laboratories"), suggesting a broader geographic origin, potentially US. The studies are retrospective, as the samples were "submitted to clinical laboratories" or from patients with existing diagnoses, and then tested in parallel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" as typically established by expert consensus (e.g., radiologists interpreting images) isn't directly applicable here in the same way. For this immunoassay, the "ground truth" for the test set is established by the performance of the predicate device, the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit. The predicate device itself has been legally marketed and its performance implicitly accepted.
The document indicates that for the "false positive" samples identified by the new device, further investigation involved immunofluorescence (P-ANCA pattern). This suggests a second-level diagnostic assessment, but it's not described as an "expert panel" establishing the initial ground truth for the entire sample set.
Therefore, the number and qualifications of experts for establishing ground truth for the entire test set are not explicitly stated as it relies on the predicate device's results.
4. Adjudication Method for the Test Set
The primary "adjudication method" for the test set is direct comparison to the predicate device. Both the Immuno Concepts RELISA® MPO-ANCA Test System and the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit were run in parallel on all 818 samples. Discrepancies were then noted.
For the 38 "false positive" samples (where the new device was positive and the predicate was negative), additional immunofluorescence testing was performed. However, this was for analysis of discrepancies rather than a primary adjudication method for establishing the initial ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases and comparing their performance with and without AI assistance. The described study is a direct comparison of a new immunoassay device (Immuno Concepts RELISA® MPO-ANCA) against a legally marketed predicate immunoassay device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). It does not involve human readers interpreting "cases" in the typical sense of imaging or clinical diagnostics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The Immuno Concepts RELISA® MPO-ANCA Test System was run independently on all samples, and its results were then compared to the results of the predicate device, which also ran independently. There was no human interpretation or interaction with the device's output influencing the reported performance metrics (sensitivity, specificity, agreement). The device's output for each sample was a positive or negative result.
7. Type of Ground Truth Used
The primary "ground truth" used for this study is the results obtained from the legally marketed predicate device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices where a new device is compared against an established, validated method. For discrepant results, some additional immunofluorescence testing was used as a secondary method of investigation.
8. Sample Size for the Training Set
The document does not provide information on a training set. This type of 510(k) submission focuses on the performance of a final, manufactured device. If the Immuno Concepts RELISA® MPO-ANCA Test System involved machine learning or an "algorithm" in a development phase, details of its training set would typically be described during its initial development, not necessarily in this specific regulatory submission which focuses on the final product's comparison to a predicate. It's likely that this immunoassay kit does not involve a machine learning algorithm in the sense of needing a "training set" for model development; rather, it's a biochemical assay for which performance characteristics are established via testing.
9. How the Ground Truth for the Training Set Was Established
As no training set is described (see point 8), this information is not applicable or provided in the document.
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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:
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Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Negative Positive
| Immuno Concepts | Positive | 53 | 38 |
|---|---|---|---|
| RELISA® MPO-ANCATest 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.
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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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Page 2
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
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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 _________________________________________________________________________________________________________________________________________________________
§ 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).