(123 days)
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.
IMMULITE Anti-TPO Ab is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer.
Here's the breakdown of the acceptance criteria and study information for the IMMULITE Anti-TPO Ab, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for agreement, sensitivity, or specificity. Instead, it presents the results of a method comparison study as the performance data that supports substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (vs. ORGenTec anti-TPO PIN Immuno Assay) |
|---|---|
| Agreement: 97.8% | |
| Relative Sensitivity: 100% | |
| Relative Specificity: 95.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 94 patient samples
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the samples were retrospective or prospective, though "patient samples" often implies retrospective samples collected for analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study compares the IMMULITE Anti-TPO Ab to a predicate device (ORGenTec anti-TPO PIN Immuno Assay), implying the results from the predicate device likely served as the comparative "truth" or reference, rather than an independent expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Since the comparison is between two quantitative immunoassays, a specific adjudication method for a test set (like 2+1 or 3+1 for qualitative assessments) might not be applicable in the same way. The comparison is based on the agreement, sensitivity, and specificity of the results against the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison between two automated immunoassay devices, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The IMMULITE Anti-TPO Ab is an automated immunoassay system, and its performance was evaluated by directly comparing its output to that of another automated immunoassay (the ORGenTec anti-TPO PIN Immuno Assay). There is no "human-in-the-loop" component to the device's operation or the comparison described.
7. The Type of Ground Truth Used
The "ground truth" for this method comparison study was the results obtained from the predicate device, the ORGenTec anti-TPO PIN Immuno Assay. The study aimed to show substantial equivalence, meaning the new device's results were comparable to an already legally marketed device.
8. The Sample Size for the Training Set
This information is not provided in the document. As this is a 510(k) summary for an immunoassay, the concept of a "training set" in the context of machine learning algorithms (where this term is most commonly used) is not directly applicable. The device's robust performance relies on its biochemical design and calibration, not a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable in the context of this type of immunoassay device described. Immunoassays are designed based on established biochemical principles and validated through empirical testing and calibration, rather than being "trained" on a dataset with an established ground truth in the way a machine learning model would be.
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K 963695
Diagnostic Products Corporation IMMULITE Anti-TPO Ab November 8, 1996
JAN | 7 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: Address:
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation:
Device Name: Trade:
Catalog Number:
Classification:
Manufacturer:
Sole U.S. Importer:
Establishment Registration Number:
Substantially Equivalent Predicate Device:
Description of Device:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
(213) 776-0180 (213) 776-0204
Edward M. Levine, Ph.D.
Director of Clinical Affairs
November 8, 1996
IMMULITE® Anti-TPO Ab Reagent system for the determination of TPO Antibodies in serum and EDTA plasma. LKTOZ (50 tests), LKTO1 (100 tests),
LKTO5 (500 tests)
Class II device, 82-JZO (21CFR 866.5870)
EURO/DPC Ltd. (Manufacturing under a Quality System- ISO 9002/EN29002/BS 5750)
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Not Applicable EURO/DPC: 2017183 DPC:
ORGenTec anti-TPO PIN Immuno Assay (K950090) Manufactured by ORGenTec, and distributed in the USA by ALPCO. Windham, NH
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 centrifygal 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 vield 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 vielding 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
11/8/96
Date
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).