IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ

K963695 · Diagnostic Products Corp. · JZO · Jan 17, 1997 · Immunology

Device Facts

• Record ID: K963695
• Device Name: IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
• Applicant: Diagnostic Products Corp.
• Product Code: JZO · Immunology
• Decision Date: Jan 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

IMMULITE Anti-TPO Ab is a solid-phase, enzyme chemiluminescent immunoassay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of antibodies against thyroid peroxidase (TPO) in serum and EDTA plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.

Device Story

IMMULITE Anti-TPO Ab is an in vitro diagnostic reagent system used with the IMMULITE Automated Analyzer. It measures anti-TPO antibodies in serum or EDTA plasma samples. The device uses a solid-phase polystyrene bead coated with purified TPO. Patient samples and buffer are incubated with the bead; anti-TPO antibodies bind to the TPO. After a centrifugal wash, an alkaline phosphatase-labeled anti-human-IgG antibody is added. A second wash removes unbound conjugate. A chemiluminescent substrate (phosphate ester of adamantyl dioxetane) is added; hydrolysis by alkaline phosphatase produces an unstable intermediate that emits light. The luminometer measures photon output, which is proportional to the anti-TPO antibody concentration. The system automates the assay process, providing quantitative results to clinicians to aid in diagnosing thyroid diseases.

Clinical Evidence

Method comparison study performed on 94 patient samples comparing IMMULITE Anti-TPO Ab to the ORGenTec anti-TPO PIN Immuno Assay. Results showed 97.8% agreement, with a relative sensitivity of 100% and a relative specificity of 95.6%.

Technological Characteristics

Solid-phase, chemiluminescent enzyme immunoassay. Solid-phase consists of a polystyrene bead. Detection uses alkaline phosphatase-labeled anti-human-IgG and a phosphate ester of adamantyl dioxetane substrate. Operates on the IMMULITE Automated Analyzer. Quantitative measurement via luminometer photon detection.

Indications for Use

Indicated for the quantitative measurement of anti-TPO antibodies in serum and EDTA plasma to aid in the clinical diagnosis of thyroid diseases.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Predicate Devices

• ORGenTec anti-TPO PIN Immuno Assay (K950090)

Submission Summary (Full Text)

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K 963695

Diagnostic Products Corporation
IMMULITE Anti-TPO Ab
November 8, 1996

JAN 17 1997

# 510 (k) Summary
## Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| --- | --- |
| Address: | |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | November 8, 1996 |
| Device Name: | IMMULITE® Anti-TPO Ab |
| Trade: | Reagent system for the determination of TPO Antibodies in serum and EDTA plasma. |
| Catalog Number: | LKTOZ (50 tests), LKTO1 (100 tests),
LKTO5 (500 tests) |
| Classification: | Class II device, 82-JZO (21CFR 866.5870) |
| Manufacturer: | EURO/DPC Ltd. (Manufacturing under a Quality System- ISO 9002/EN29002/BS 5750) |
| Sole U.S. Importer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| Establishment Registration Number: | EURO/DPC: Not Applicable
DPC: 2017183 |
| Substantially Equivalent Predicate Device: | ORGenTec anti-TPO PIN Immuno Assay (K950090)
Manufactured by ORGenTec, and distributed in the USA by ALPCO, Windham, NH |
| Description of Device: | IMMULITE Anti-TPO Ab is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer. |

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Diagnostic Products Corporation
IMMULITE Anti-TPO Ab
November 8, 1996

## Intended Use of the Device:

IMMULITE Anti-TPO Ab is a solid-phase, enzyme chemiluminescent immunoassay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of antibodies against thyroid peroxidase (TPO) in serum and EDTA plasma. It is intended strictly for *in vitro* diagnostic use as an aid in the clinical diagnosis of thyroid diseases.

## Performance Equivalence:

Diagnostic Products Corporation (DPC) asserts that the IMMULITE Anti-TPO Ab produces substantially equivalent results to other commercially marketed Anti-TPO assays, such as the ORGenTec anti-TPO PIN Immuno Assay. Each product is intended strictly for *in vitro* diagnostic use to aid in the clinical diagnosis of thyroid diseases.

## Technological Comparison to Predicate:

IMMULITE Anti-TPO Ab is a solid-phase, chemiluminescent enzyme immunoassay. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with highly purified TPO.

The prediluted patient sample and a buffer matrix are simultaneously introduced into the Test Unit, and incubated for 30 minutes at 37°C with intermittent agitation. During this time anti-TPO antibodies in the sample bind to the TPO-coated bead. The serum/buffer mixture is then removed by a centrifugal wash.

An alkaline phosphatase-labeled anti-human-IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound enzyme conjugate-and thus also the photon output, as measured by the luminometer- is proportional to the concentration of anti-TPO antibodies in the sample.

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Diagnostic Products Corporation
IMMULITE Anti-TPO Ab
November 8, 1996

## Technological Comparison to Predicate (continued):

The ORGenTec anti-TPO PIN Immuno Assay is an indirect solid phase enzyme immunometric assay (ELISA) based on coated micropins corresponding to a microplate format. Designed for the quantitative measurement of IgG class autoantibodies directed against human thyroid peroxidase, called microsomal antigen. The Pin assay employs a unique antigen coated micropin technology. Coated PinStrips act as the transferable solid phase. Seven pre-scored breaking lines allow strips to be used in a 2, 4, 6, 8, or 10 row strip assay, while a complete plate provides for 96 determinations. The assay takes place in three reaction phases:

Phase 1: Standards, controls and patient samples are pipetted into the wells of the first microplate. Micropins, coated with highly purified antigen, are immersed into the samples allowing any antibody present to bind to the pin surface. After a 10 minute incubation, the pins are removed, non-reactive components are washed away by dipping the pins into wash buffer.

Phase 2: The pins are then immersed into a second microplate containing enzyme conjugate, which recognizes the autoantibodies bound to the immobilized antigens. Any conjugate not specifically bound, is washed away after a 10 minute incubation.

Phase 3: The pins are then immersed into the wells of a third microplate containing chromogenic substrate solution of OPD which changes from colorless to yellow during a 5 minute incubation. Color development is stopped by dispensing 3M sulfuric acid. The amount of color is directly proportional to the concentration of IgG present in the original sample. Optical density is read with a microplate reader at 490 nm. Bichromatic measurement is recommended with a 650 nm reference.

## Method Comparison:

The IMMULITE Anti-TPO Ab procedure was compared to the ORGenTec anti-TPO PIN Immuno Assay on 94 patient samples yielding an agreement of 97.8% and a relative sensitivity and specificity of 100% and 95.6%, respectively.

## Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DBC substantial equivalence for IMMULITE Anti-TPO Ab.

Edward M. Levine, Ph.D.
Director of Clinical Affairs
Date: 11/8/96

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