IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

K013432 · Immuno Concepts, Inc. · KTL · Nov 29, 2001 · Immunology

Device Facts

• Record ID: K013432
• Device Name: IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
• Applicant: Immuno Concepts, Inc.
• Product Code: KTL · Immunology
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

Device Story

Indirect fluorescent antibody test system for detection of IgG anti-nDNA antibodies in human serum; used as an aid in diagnosing systemic lupus erythematosus. Device utilizes substrate slides with concentric circles to minimize cross-contamination and integrated positive/negative/PBS control wells. Procedure involves manual application of patient serum to slides; no blotting required after washing steps. Results are interpreted by clinical laboratory personnel via fluorescence microscopy. Output is semiquantitative titer value. Device provides diagnostic support for clinicians evaluating patients for systemic lupus erythematosus.

Clinical Evidence

Clinical study compared subject device to predicate using 223 samples (121 clinical, 100 donors, 2 WHO standards). Results: 93.3% relative sensitivity, 100% relative specificity, 100% positive predictive value, 99.0% negative predictive value, 99.1% overall agreement. Reproducibility testing: intra-assay (30 replicates) and inter-assay (15 lots) showed Geometric Coefficient of Variation of 0.78% and 0.82% respectively; all titers within one dilution of median.

Technological Characteristics

Indirect immunofluorescence assay; substrate slide with concentric wells; manual processing; no blotting required. Performance validated against WHO standards. Class II device (21 CFR 866.5100).

Indications for Use

Indicated for screening and semiquantitative detection of IgG anti-nDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Predicate Devices

• Crithidia lucilliae DS DNA Kit (Diagnostic Use) (K930987)

Submission Summary (Full Text)

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NOV 2 9 2001

Immuno
concepts

*510(k) SUMMARY*

**STORY BOMB KIT!**

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Date Prepared: November 8, 2001 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device:

- · Trade Name IgG Anti-nDNA Fluorescent Test System
- · Common Name IgG Anti-nDNA Fluorescent Test System
- Classification Name Anti-DNA Indirect Immunofluorescent Solid Phase (21 CFR 866.5100)

Legally marketed device with which this device has been shown to be equivalent: "Crithidia lucilliae DS DNA Kit (Diagnostic Use)" distributed by The Binding Site, Ltd., Los Angeles, CA 90064 (K930987, 8/10/93).

### Description:

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.

### Intended Use:

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

Summary of Technological Characteristics Compared to the Predicate Device: Technologically, this device is similar to the predicate device with the following exceptions:

- 1. The substrate slide wells concentric circles which decrease potential cross contamination of patient sera.
- 2. The slides include three additional wells designated positive (+), negative (-), and phosphate buffered saline (PBS) to insure proper performance of controls on slides.
- 3. Unlike the predicate device and other similar kits, the Immuno Concepts slides are not blotted after each washing step.

### Description of Laboratory Data That Indicate Substantial Equivalence:

The Immuno Concepts IgG Anti-nDNA Fluorescent Test System was compared to the "Crithidia lucilliae DS DNA Kit´ (Diagnostic Use)" distributed by The Binding Site, Ltd., Los Angeles, CA 90064 (K930987, 8/10/93). The population studied consisted of 121 samples which were submitted to clinical laboratories for anti-nDNA testing, 100 blood donors, and 2 WHO standards that are known to contain ant-nDNA antibodies. All 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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#### Predicate IgG anti-nDNA Test Positive Negative

| Immuno<br>Concepts | Positive | 28 | 0 |
|--------------------|----------|----|-----|
| IgG anti-nDNA | Negative | 2 | 193 |

These data yield the following statistics: relative sensitivity, 93.3%;
100%; mediation 1000 memitive mrodictive value. 100%; negative These data yield the following scaller predictive value, 100%; negative
relative specificity, 100%; positive predictive value, 100 % relative specificity, 1000, poblem. I
predictive value, 99.0%; and overall agreement, 99.1%

One of the two "false negative" samples was negative for antinuclear one of the two "false negative" samples was negation in most clinical antibodies by indirect immunoriuorescence using hip work.
have met the screening criteria for anti-nDNA testing in most clinical laboratories.

To determine intra-assay reproducibility, a single anti-mDNA positive serum To determine intra-assay a single technologist in a single run. The was tested in 30 replicates by a single technologics ha december in Coefficient
median and mode values for these data were 1:160, with a Getemining median and mode values for these acta were fr.ov. Metro by examining
of Variation of 0.78%. Inter-assay variability was it was run in of Variation of 0.78%. Incel-assay variability namma it was run in
the titer values for a single anti-mDNA positive serum as it was data the titer values for a single and mode walves for these data were
fifteen different lots of kirs officion of Variation of O.82%. In both the fifteen different lots of kits. The median and mode variation of 0.828. In both the or also 1:16, with a Geomeric Coefficient of Variation of Vol. 1:16.
inter-assay and intra-assay tests, all titer values fell within plus or minus
tion intra-assay tests, all ti one dilution of the median.

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 a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HL" are arranged in a semi-circle around the left side of the eagle, and the letters "SA" are on the right side.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 9 2001

Eric S. Hoy, Ph.D., SI(ASCP) Chief, Scientific Officer Immuno Concepts Incorporated 9779 "D" Business Park Drive Sacramento, CA 95827

Re: k013432 Trade/Device Name: IgG Anti-nDNA Fluorescent Test System Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: KTL Dated: October 1, 2001 Received: October 16, 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 I has letter will and my 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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): ко13432

IgG Anti-nDNA Fluorescent Test System Device Name:

## Indications for use:

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This quantitacive dececcion of igo anor head mo.
test system is to be used as an aid in the diagnosis of systemic lupus erythematosus .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sousan S, Altule

510(k) Number k013432

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________