An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of patients with necrotizing vasculitides.

Device Description

This assay is an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the IMMCO Diagnostics ImmuGlo™ ANCA Test System, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (IMMCO ImmuGlo™ ANCA Test System)
Relative Specificity: Not explicitly stated, but derived from predicate's performance against ground truth (assuming 100% sensitivity for predicate against its own ground truth from clinical test data, Scimedx: 73 true negative out of 73 total negative samples)	91% (calculated from the comparative study with Scimedx: 73 true negative / (73 true negative + 7 false positive)
Relative Sensitivity: Not explicitly stated, but derived from predicate's performance against ground truth (assuming 100% sensitivity for predicate against its own ground truth from clinical test data, Scimedx: 49 true positive out of 49 total positive samples)	100% (calculated from the comparative study with Scimedx: 49 true positive / (49 true positive + 0 false negative)
Relative Agreement: Not explicitly stated for predicate in a standalone table, but likely expected to be high	95% (calculated from the comparative study with Scimedx: (49 true positive + 73 true negative) / 129 total samples)

Note: The acceptance criteria are implicitly based on the performance of the predicate device (Scimedx) to demonstrate substantial equivalence. The document doesn't explicitly state numerical acceptance criteria before showing the results, but rather presents the results against the predicate and concludes substantial equivalence.

Study Proving Device Meets Acceptance Criteria

2. Sample Size and Data Provenance:
* Test Set Sample Size: 129 samples.
* Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective as it compares IMMCO's test performance against a predicate device on a fixed set of samples.

3. Number of Experts and Qualifications for Ground Truth:
* Number of Experts: Not specified.
* Qualifications of Experts: Not specified. However, the initial comparison uses a legally marketed predicate device (Scimedx Corporation's ANCA Test System) as the reference, which implies established clinical accuracy. For discrepant samples, ELISA for MPO or PR3 antigens (two major ANCA antigens) was used, which typically involves laboratory testing performed by qualified personnel.

4. Adjudication Method for Test Set:
* Adjudication Method: Not explicitly detailed for the primary comparison. The comparison is a direct concordance study between the IMMCO device and the Scimedx predicate device.
* For the 7 discrepant samples (IMMCO positive, Scimedx negative), ELISA for MPO or PR3 antigens was used. This acts as a secondary, more specific adjudication method, confirming the "true positivity" for 6 out of these 7 samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, a MRMC comparative effectiveness study was not done. This evaluation focuses on the performance of an in-vitro diagnostic test system, which does not involve human readers interpreting images or results in the same way an imaging AI would. The comparison is between two commercial assay systems.

6. Standalone Performance:
* Yes, a standalone performance was done, in the sense that the IMMCO device's results were generated independently on the 129 samples, and then compared to the results from the Scimedx device on the same samples. The reported "Relative Specificity," "Relative Sensitivity," and "Relative Agreement" are metrics of its performance compared to the predicate device.

7. Type of Ground Truth Used:
* The primary "ground truth" for the main comparison was the results from a legally marketed predicate device (Scimedx ANCA Test System).
* For the 7 discrepant samples, the "ground truth" was established by ELISA results for MPO or PR3 antigens (pathology/laboratory testing).

8. Sample Size for the Training Set:
* Not applicable. This document describes a traditional in-vitro diagnostic assay comparison, not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development. The device itself is a laboratory kit.

9. How Ground Truth for Training Set Was Established:
* Not applicable. As above, there is no training set for this type of device.

Summary

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NOV 3 0 1998

Image /page/0/Picture/1 description: The image shows a logo for IMMCO Diagnostics. The logo features a stylized letter "I" above the word "IMMCO" and the word "DIAGNOSTICS" below it. The letter "I" is large and bold, and the words "IMMCO" and "DIAGNOSTICS" are in a smaller, sans-serif font.

K982878

510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter:	IMMCO Diagnostics, Inc.
Address:	60 Pineview DriveAmherst, NY 14228
Phone:	(716) 691-0091
Fax:	(716) 691-0466
Contact:	Kevin Lawson
Date of Summary:	8/13/98
The assigned 510(k) number is:	K982898
Name of Device:	ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System
Common Name:	ANCA IFA
Classification Name:	866.5660 Multiple autoantibodies immunological test system
Equivalent Device:	• Anti-neutrophil Cytoplasmic Antibody (ANCA) Test Systemfrom Scimedx Corporation• NOVA Lite™ ANCA System by INOVA Diagnostics

Intended Use:

This assay is an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.

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Image /page/1/Picture/0 description: The image is a logo for IMMCO Diagnostics. The logo features a stylized letter "I" in bold, black font, with a curved design at the top. Below the "I", the word "IMMCO" is printed in a bold, sans-serif font, with the word "DIAGNOSTICS" printed in a smaller font size underneath.

510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

Technological Characteristics:

Technological characteristics of this device compared with the 2 equivalent devices listed above is summarized in the following table:

	IMMCO	SciMedx	INOVA
Indirect Immunofluorescence Assay	Y	Y	Y
Detection of Autoantibodies in Sera	ANCA	ANCA	ANCA
Screening for Ab's and/or Determination of Ab Titers	Y	Y	Y
Screening Dilution	1:20	1:20	1:20
Similar Methodology	Y	Y	Y
Substrate Used	human PMN cells	human PMN cells	human PMN cells
Fluorescein-Labeled Conjugate, Anti-human IgG	Y	Y	Y
Evans Blue Counterstain	in wash (optional)	in conjugate	in conjugate
Positive Control Sera	cANCA and pANCA	cANCA	cANCA and pANCA
Negative Control Serum	Y	Y	Y
Buffered Diluent	Y	Y	Y
Phosphate Buffered Saline	Y	Y	Y
Mounting Medium	Y	Y	Y
Storage of Substrate Slides	2°-8°C	2°-8°C	2°-8°C

Clinical Test Data to Demonstrate Substantial Equivalence:

Substantial equivalence between the IMMCO and Scimedx assays is demonstrated in the table below.

		IMMCO
		Positive	Negative	Total
Scimedx	Positive	49	0	49
	Negative	7	73	80
	Total	56	73	129

Relative Specificity: 91% Relative Sensitivity: 100% Relative Agreement: 95%

Conclusions:

This test is substantially equivalent to that of Scimedx. The seven discrepant samples observed by indirect immunofluorescent method in the table above were tested by ELISA for antibodies to mveloperoxidase (MPO) or proteinase 3 (PR3) antigens, the two major antigens associated with ANCA. Of the seven samples positive on IMMCO's IFA system and negative on the Scimedx IFA system, all but one tested positive by ELISA, suggesting the true positivity of these samples. This discrepancy can therefore be accounted for by the greater sensitivity of the ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kevin J. Lawson Chief Information Officer IMMCO DIAGNOSTICS 60 Pineview Drive Amherst, NY 14228

K982898 Re:

Trade Name: ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System Regulatory Class: II Product Code: MOB November 13, 1998 Dated: Received: November 16, 1998

Dear Mr. Lawson:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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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"(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 (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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510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

INDICATIONS FOR USE STATEMENT

K982898 510(K) Number:

ImmuGlo" Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System Device Name:

Indications For Use:

An indirect immunofluorescence antibody test for the detection and semiquantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of patients with necrotizing vasculitides.

Peter E. Maher

(Division Sign-Off, Division of Clinical Laboratory Devices 98 2898 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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).