EIA SMDP IMMUNOASSAY

K132631 · Phadia US, Inc. · LKP · Aug 29, 2014 · Immunology

Device Facts

• Record ID: K132631
• Device Name: EIA SMDP IMMUNOASSAY
• Applicant: Phadia US, Inc.
• Product Code: LKP · Immunology
• Decision Date: Aug 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

EliA SmD⁺ is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) to aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmD⁺ uses the EliA IgG method on the instrument Phadia 100. EliA SmD⁺ is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) to aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmD⁺ uses the EliA IgG method on the instrument Phadia 250.

Device Story

EliA SmD⁺ is a fluoroenzymeimmunoassay for detecting IgG antibodies against SmD3 peptide in human serum/plasma. Input: patient serum/plasma samples. Operation: samples are incubated in wells coated with synthetic SmD3 peptide; bound antibodies are detected via β-galactosidase-labeled anti-human IgG conjugate; fluorescence is measured after adding development solution. Performed on automated Phadia 100 or Phadia 250 instruments. Output: semi-quantitative concentration (U/mL) compared against a stored calibration curve. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing SLE by identifying specific autoantibodies. Benefits include automated, standardized detection of Sm antibodies compared to manual ELISA methods.

Clinical Evidence

Clinical performance evaluated using 350 specimens (100 SLE, 250 other autoimmune/infectious conditions). Sensitivity: 23.0% (95% CI: 15.2–32.5%) to 25.0% (95% CI: 16.9–34.7%) depending on equivocal handling. Specificity: 97.6% (95% CI: 94.8–99.1%) to 98.4% (95% CI: 96.0–99.6%). Method comparison with predicate (n=354) showed 97.5% total agreement. Analytical studies included precision (CV <10%), linearity, and interference testing.

Technological Characteristics

In vitro semi-quantitative immunoassay; utilizes EliA IgG method; compatible with Phadia 100 and Phadia 250 automated instruments; detects IgG antibodies to Sm in human serum and plasma.

Indications for Use

Indicated for the in vitro semi-quantitative measurement of IgG antibodies to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other clinical and laboratory findings.

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).

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

PHADIA US, INC. C/O MR. MARTIN ROBERT MANN SENIOR REGULATORY AFFAIRS MANAGER 4169 COMMERCIAL AVENUE PORTAGE, MI, 49002

Re: k132631

| Trade/Device Name: | EliA™ SmDP Immunoassay |
|--------------------|------------------------------------------------|
| Regulation Number: | 21 CFR §866.5100 |
| Regulation Name: | Antinuclear Antibody Immunological Test System |
| Regulatory Class: | Class II |
| Product Code: | LKP |
| Dated: | July 28, 2014 |
| Received: | July 31, 2014 |

Dear Mr. Mann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Elizabeth A. Stafford -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K132631

Device Name EliA(TM) SmDP

#### Indications for Use (Describe)

EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.

EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.

## Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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