(43 days)
This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.
This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.
The Immuno Concepts RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 was evaluated for substantial equivalence to the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. The study involved a comparison of both devices using a diverse set of human serum samples.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria values for relative sensitivity, specificity, and overall agreement. However, the study aims to demonstrate substantial equivalence to the predicate device. The reported performance metrics based on the comparison serve as the de facto demonstration of equivalence.
| Metric | Reported Device Performance (%) |
|---|---|
| Relative Sensitivity | 97.8 |
| Relative Specificity | 98.6 |
| Overall Agreement | 98.4 |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 756 samples (206 samples submitted for ANCA, MPO, PR3 testing, 7 Churg-Strauss syndrome, 18 vasculitis, 25 Wegener's granulomatosis, 261 male blood donors, 239 female blood donors).
- Data Provenance: The origin of the samples (e.g., country) is not explicitly stated. The samples were from patients with specific diagnoses, those submitted for ANCA testing, and blood donors, indicating a mix of clinical and presumably healthy populations. The data appears to be retrospective, collected from existing clinical and donor samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a legally marketed predicate device, implying the predicate device's results are used as the reference, rather than independent expert adjudication.
However, for the 8 "false positive" samples identified by the new device, additional immunofluorescence patterns (P-ANCA, C-ANCA) were noted, and patient diagnoses (Wegener's granulomatosis, Churg-Strauss syndrome) were considered. This suggests some level of clinical context or expert review for specific discordant cases, but a formal "ground truth establishment" process by experts is not detailed.
4. Adjudication Method for the Test Set:
No formal adjudication method (e.g., 2+1, 3+1) for the test set is described. The study primarily compares the performance of the new device against the predicate device. For discordant results, especially "false positives" of the new device, immunofluorescence patterns and patient diagnoses were used to provide further context, suggesting a form of retrospective review rather than pre-defined adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed or described. This study focuses on the performance of an in vitro diagnostic test system, not on human readers' interpretive skills with or without AI assistance.
6. Standalone Performance:
Yes, a standalone performance study was conducted. The Immuno Concepts RELISA® PR3-ANCA Test System was tested independently on the 756 samples, and its results were then compared to those of the predicate device. The performance metrics (relative sensitivity, specificity, overall agreement) reflect the standalone performance of the new device in relation to the predicate.
7. Type of Ground Truth Used:
The "ground truth" for this study is established by the results of the predicate device, the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. In cases of disagreement, additional clinical information such as immunofluorescence patterns and patient diagnoses were considered to analyze potential "false" results, implying a form of expert or clinical consensus interpretation for discordant cases.
8. Sample Size for the Training Set:
The document describes a comparison study against a predicate device and does not mention a separate training set. This suggests that the device being studied (Immunoconcepts RELISA PR3-ANCA) was likely developed using its own internal development/training data, which is not disclosed in this 510(k) submission. The samples described in the study are explicitly designated for the comparison or test phase.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed in this document, the method for establishing its ground truth is not provided.
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NOV 1 4 2001
Date Prepared: July 23, 2001 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device:
- · Trade Name RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3
- · Common Name Anti-PR3 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-PR3 Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK, K981029.
Description:
This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.
Intended Use:
This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis 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® PR3 Test System was compared to the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK. (K981029). The population studied consisted of 206 samples which were submitted to clinical laboratories for ANCA, MPO and PR3 testing, but without specific diagnoses, 7 samples which were 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, and 239 samples from female blood donors. All samples were tested in parallel on the predicate device and the subject Based on this comparison, the following data were obtained: device.
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Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit Positive Negative
| Immuno Concepts | Positive | 179 | 8 |
|---|---|---|---|
| RELISA® PR3-ANCATest System | Negative | 4 | 563 |
These data yield the following statistics: relative sensitivity, 97.8%; relative specificity, 98.6%; and overall agreement, 98.4%
Among the 8 "false positive" samples, 2 showed a P-ANCA pattern by immunofluorescence, 4 showed a C-ANCA pattern by immunofluorescence, and 2 did not demonstrate any immunofluorescent pattern. Two of the samples that showed a C-ANCA pattern by immunoflurescence and a positive RELISA® PR3 were from patients with a diagnosis of Wegener's granulomatosis, and one of the samples that showed a P-ANCA pattern by immunofluorescence and a positive RELISA® PR3 was from a patient with a diagnosis of Churg-Strauss syndrome. These samples may actually represent "false negative" results on the predicate device.
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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Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 2098 Gaither Road, Rockville MD 20850. The text is in black and is aligned to the left.
Eric Hoy, Ph.D., SI (ASCP) Chief Scientific Officer, Regulatory Affairs Immuno Concepts, Inc. 2280 Springlake Road, Suite 106 Dallas, Texas 75234
NOV 1 4 2001
Re: K013283
Trade/Device Name: Immuno Concepts RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 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 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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510(k) number (if known): K013a83
RELISA® PR3-ANCA Test System for Antibodies Device Name: to Proteinase 3
Indications for use:
This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.
Sousan S Altaie
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510(k) Numbe
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (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).