Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard ELISA assay with results calculated against a calibrator curve, which is a traditional method and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related terms.

Therapeutic

No.
This device is an in vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to treat a disease or condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the results of the assay are to be used "as an aid to the diagnosis of Wegener's granulomatosis," indicating its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical test kit involving microtiter strips, reagents, and a process of binding and detection based on color intensity measured by absorbance. This is a hardware-based in vitro diagnostic device, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Device Description" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."
Intended Use: The "Intended Use / Indications for Use" clearly describes the device's purpose as an aid to the diagnosis of Wegener's granulomatosis by detecting antibodies in human sera. This is a diagnostic purpose performed outside of the living body (in vitro).
Methodology: The device uses an ELISA method to analyze human serum, which is a common in vitro diagnostic technique.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.

Product codes (comma separated list FDA assigned to the subject device)

MOB 82

Device Description

The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.

The wells of the microtiter strips are coated with purified proteinase 3. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.

The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.

After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Sensitivity and Specificity
A total of 364 frozen retrospective sera with clinical characterization were assayed.

Clinical Sensitivity:
- WG = 65/70 = 92.9% (95% confidence interval = 86.7-99.0%)
- MP = 26/52 = 50.0% (95% confidence interval = 36.1-63.9%)
Clinical Specificity:
- SLE = 38/39 = 97.4% (95% confidence interval = 92.4-100%)
- RA = 17/17 = 100% (95% confidence interval = 82.7-100%)
- GBM = 58/62 = 93.6% (95% confidence interval = 87.3-99.8%)
- Normals = 120/120 = 100% (95% confidence interval = 97.5-100%)
  (Equivocal samples excluded from calculations)

Relative Sensitivity and Specificity of the Wielisa PR-3 ANCA Compared to C-ANCA IFA
A total of 245 frozen retrospective sera were assayed.

Relative Sensitivity = 78/81 = 96.3 % (95% Confidence Interval: 92.1 - 100.0 %)
Relative Specificity = 148/161 = 91.9 % (95% Confidence Interval: 87.6 - 96.2 %)
Relative Accuracy = 226/242 = 93.4 % (95% Confidence Interval: 90.2 - 96.6 %)
(Sera falling in the equivocal range were excluded from the calculations)

Relative Sensitivity and Specificity of the Wielisa PR-3 Kit Compared to an Alternate ELISA
A total of 120 frozen retrospective sera were assayed.

Relative Sensitivity = 37/37 = 100 % (95% Confidence Interval: 92.0 - 100 %)*
Relative Specificity = 79/81 = 97.5 % (95% Confidence Interval: 94.1 - 100 %)
Relative Accuracy = 116/118 = 98.3 % (95% Confidence Interval: 95.9 - 100 %)
(* One false negative was included in this caclulation. ** Both sera were from vasculitis patients)
(Sera falling in the equivocal range were excluded from the calculations)

Batch to batch variation.
Determined by testing 4 different samples in duplicate across four different batches.

Sample 1: Mean value 25 units, SD 2.3, CV 9.1%
Sample 2: Mean value 29 units, SD 4.1, CV 14.3%
Sample 3: Mean value 68 units, SD 8.7, CV 12.7%
Sample 4: Mean value 76 units, SD 6.7, CV 8.9%

Inter-assay precision.
Determined by testing 2 different samples in duplicate across six different runs.

Sample 1: Mean value approx 75 units
Sample 2: Mean value approx 22 units

Intra-assay precision.
Determined by testing one sample in 80 wells.

Linearity.
Determined for serial two-fold dilutions of seven positive sera. The values were compared to log2 of dilution by standard linear regression. The data indicates that the assay has a linear relationship with serum dilution.

Serum 1: r = 0.945
Serum 2: r = 0.942
Serum 3: r = 0.851
Serum 4: r = 0.935
Serum 5: r = 0.908
Serum 6: r = 0.811
Serum 7: r = 0.931

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical Sensitivity:
WG = 92.9%
MP = 50.0%

Clinical Specificity:
SLE = 97.4%
RA = 100%
GBM = 93.6%
Normals = 100%

Relative Sensitivity compared to C-ANCA IFA = 96.3%
Relative Specificity compared to C-ANCA IFA = 91.9%
Relative Accuracy compared to C-ANCA IFA = 93.4%

Relative Sensitivity compared to Alternate ELISA = 100%
Relative Specificity compared to Alternate ELISA = 97.5%
Relative Accuracy compared to Alternate ELISA = 98.3%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Immunoscan PR-3 ANCA ELISA Kit

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

K974167

Summary of Safety and Effectiveness Information PR-3 ANCA Test Kit

FEB 17 1998

Wieslab AB Ideon Research Park S-223 70 Lund Sweden Contact person: Dr. Jorgen Wieslander Telephone: 46-46-182840 Date of preparation: Jan 19, 1998

【.

Description of Device: The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent 11. assay (ELISA) for the detection and semi-quantitation of lgG antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.

The wells of the microtiter strips are coated with purified proteinase 3. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating,

The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.

After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

111. Predicate Device

The PR-3 ANCA test is substantially equivalent to the Immunoscan PR-3 ANCA ELISA Kit. Equivalence is demonstrated by the following comparative results:

1

Table 1. Clinical Sensitivity and Specificity A total of 364 frozen retrospective sera with clinical characterization were assayed. The following table summarizes the data.

| Control and
Disease groups | Total
number | Negative
20 units |
|-------------------------------|-----------------|-----------------------|--------------------------|-----------------------|
| Healthy Normals: | 120 | 120 | 0 | 0 |
| WG: | 70 | 5 | 0 | 65 |
| MP: | 55 | 26 | 3 | 26 |
| SLE: | 40 | 38 | 1 | 1 |
| RA: | 17 | 17 | 0 | 0 |
| Anti-GBM nephritis: | 62 | 58 | 0 | 4 |

GBM = glomerular basement membrane

WG = Wegener's granulomatosis, SLE = systemic lupus erythematosus

MP = microscopic polyangiitis

RA = rheumatoid arthritis

Clinical Sensitivity (Equivocal samples excluded from calculations)

WG = 65/70 = 92.9%	95% confidence interval = 86.7-99.0%
MP = 26/52 = 50.0%	95% confidence interval = 36.1-63.9%

Clinical Specificity (Equivocal samples excluded from calculations)

SLE	= 38/39	= 97.4%	95% confidence interval = 92.4-100%
RA	= 17/17	= 100%	*95% confidence interval = 82.7-100%
GBM	= 58/62	= 93.6%	95% confidence interval = 87.3-99.8%
Normals	= 120/120	= 100%	*95% confidence interval = 97.5-100%

The 95% confidence intervals were calculated using the normal method. *The 95% confidence intervals were calculated assuming one false positive.

2

Table 2 A total of 245 frozen retrospective sera were assayed on the Wielisa PR-3 ANCA ELISA and IFA. The following Table summarizes the relative sensitivity and specificity.

Relative Sensitivity and Specificity of the Wielisa PR-3 ANCA Compared to C-ANCA IFA

		Positive	Equivocal	Negative	Total
C-ANCA
IFA	Positive	78	0	3	81
	Negative	13	3	148	164
	Total	91	3	151	245

Sera falling in the equivocal range were excluded from the following calculations

			95% Confidence Interval
Relative Sensitivity	= 78/81	= 96.3 %	92.1 - 100.0 %
Relative Specificity	= 148/161	= 91.9 %	87.6 - 96.2 %
Relative Accuracy	= 226/242	= 93.4 %	90.2 - 96.6 %

3

Table 3 A total of 120 frozen retrospective sera were assayed by the Wielisa PR-3 ANCA ELISA and by an alternate commercial ELISA. The following table summarizes the relative sensitivity and specificity of the assay.

Relative Sensitivity and Specificity of the Wielisa PR-3 Kit Compared to an Alternate ELISA .• -•

PR-3 Wielisa

		Positive	Equivocal	Negative	Total
	Positive	37	0	0	37
Alternate
ELISA	Equivocal	1	0	1	2
	Negative	2**	0	79	81
	Total	40	0	80	120

Sera falling in the equivocal range were excluded from the following calculations

		95% Confidence Interval
Relative Sensitivity	= 37/37 = 100 %	92.0 - 100 %*
Relative Specificity	= 79/81 = 97.5 %	94.1 - 100 %
Relative Accuracy	= 116/118 = 98.3 %	95.9 - 100 %

One false negative was included in this caclulation.

** Both sera were from vasculitis patients

4

Table 4. Batch to batch variation.

Batch to batch variation was determined by testing 4 different samples in duplicate. Results were obtained for four different batches.

Sample	Mean value	SD	CV %
1	25 units	2.3	9.1
2	29 units	4.1	14.3
3	68 units	8.7	12.7
4	76 units	6.7	8.9

Table 5. Inter-assay precision.

Inter-assay precision was determined by testing 2 different samples in duplicate. Results were obtained for six different runs.

| the change on the collection in the contraction to the contraction and the collection of the color controlled in
AND A LINE BOOK OF CHARREN FOR AND ANDREA
Sample | I a sual manimal a minutes
Mean value | LE LEB LE LE RE MENSION AN FERRENCE CHARRIES CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT CHARACT C
C | AT R CLEAR SECTIONAL
STAR I IT AN ANNUAL CAR AN AN AN AN AN AN AN AN AN AN A CHANAL AND AND THE CHANALY
CV %
S | ------------ |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 75 units | 1000 0 - | 1
ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | |
| | 22 units
t

| 1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | t
100 1 4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MILLE LE LEAR MERICANAL PARK
Comments of Concession of Concession of Children Comments of Children Comments |

Table 6. Intra-assay precision.

Intra-assay precision was determined by testing one sample in 80 wells.

| .
. No and more of the may be | THE THE THE THE FELLER FOR COLLECT COLLEGIAL COLLEGIAL COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLEGION
100 Total Property
. | LAND AN LINERAL CLAND LE LE E REAL LE LEBELLER BERE AND AND AND AND A BELL | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| . LE ENRECE E M LE MULA MOND BELLINER LE E REVIEWS! FINN BER
The former and consisted to the first from Party of the Arman Comments of the Children and Children and Children and Children and Children and Children and Children and Child
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -
100
CANNOR COLOR COLLEGION CONSULT CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION |

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | 1
CORRELLE OF CONSULTION COLLEGION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO

A STORE STATE OF LEASE OF CANADA AN AND AND ALL | |

Table 7. Linearity

.

The values were determined for serial two-fold dilutions of seven positive sera. The values were compared to log2 of dilution by standard linear regression. The data in Table 7 indicates that the assay has a linear relationship with serum dilution.

Serum	Neat	1:2	1:4	1:8	1:16	1:32	1:64	r
1	168	95	57	34	15	5		0.945
2	84	43	23	13	5			0.942
3	230	80	50	31	19	7		0.851
4	200	130	81	38	19	10	6	0.935
5	269	146	64	34	20	9.5		0.908
6	276	75	46	26	12	8		0.811
7	141	73	50	30	16	8		0.931

5

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

WEISLAB AB William L. Boteler c/o IMMUNO PROBE, INC. 1306 Bailes Lane, Suite F Frederick, MD 21701

FFB 17 1998

Re: K974167 Trade Name: Wielisa PR-3 ANCA Test System Regulatory Class: II Product Code: MOB 82 Dated: January 19, 1998 January 20, 1998 Received:

Dear Mr. Boteler:

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 Requlations, 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.

6

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 Putman

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

7

Page 1 of 1

510(k) Number: Not known ¥974167

Device Name: Wielisa PR-3 ANCA Test Kit

Indications For Use: The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis.

Peter E. Makin

(Division Sign-Off) (Division of Clinical Laboratory Devices LG 74 16

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

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