(275 days)
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No
The device description and performance studies detail a standard immunoassay (ELISA) process with spectrophotometric reading and calculation of results in EU/ml, which are then reported as positive or negative based on a cutoff. There is no mention of AI/ML algorithms being used for data analysis, interpretation, or decision-making.
No
This device is an in vitro diagnostic (IVD) test designed to detect antibodies for diagnostic purposes, not to treat or cure a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in diagnosis of limited cutanteous systemic sclerosis / CREST."
No
The device description clearly outlines a physical immunoassay kit involving microwells, reagents, and a spectrophotometer for reading results. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis..." This clearly indicates it's designed to be used on samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test (ELISA) performed on human serum samples. This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The document describes various performance studies conducted on human samples (serum) to evaluate the device's accuracy and reliability in detecting the target antibodies. These types of studies are required for IVD devices.
- Predicate Device: The mention of a "Predicate Device" which is also an ELISA for detecting anti-centromere antibodies further confirms its classification as an IVD. Predicate devices are used in regulatory submissions for new IVDs to demonstrate substantial equivalence.
The entire context of the document, from the intended use to the performance data and predicate device information, points to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutanteous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.
An enzyme linked immunoassay (EUSA) for the qualitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutaneous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
LJM, antinuclear antibody (enzyme-labeled), antigen, controls
LJM, Antinuclear Antibody (Enzyme-Labeled), Antigen, Control
Device Description
Antinuclear antibodies (ANA) occur in sera of patients with various connective tissue disorders such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), systemic sclerosis / scleroderma (SSc), polymyositis and Siögren's syndrome. These ANA are directed against nucleding DNA, nucleohistone and various extractable nuclear antigens (ENA) such as RNP, Sm, SS-A (Ro), SS-B (La), Centromere, Scl-70 (topoisomerase I) and Jo-1.
The anti-centromere antibody produces a discrete speckled pattern in HEp-2 immunofluorescence assays, and has been observed in 38-64% of patients with the limited cutaneous systemic sclerosis (IcSSc) or CREST syndrome variant of systemic sclerosis or scleroderma. Centromere antibodies bind the kinetochore of mitotic chromosomes and the pre-kinetochore of interphase cells. Immunoblotting analysis indicates that centromere antibodies recognize at least six epitopes on three chromosomal proteins: CENP-A (17-19kD), CENP-B (80kD), and CENP-C (140kD). CENP-A and CENP-B have been cloned and while CENP-B is the primary autoantigen, it appears that assays incorporating both antigens produce results with greater sensitivity and more comparable to immunofluorescence.
This test is performed as a solid phase immunoassay. Microwells are coated with recombinant purified CENP-A centromere antigens. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the centromere antibodies are detected by adding an enzyme labeled anti-human lgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
Method Comparison: Both kits were tested with well-characterized lcSSc / CREST subjects and disease controls.
Sample size for method comparison:
IMMCO Centromere Ab ELISA - Positive: 71, Negative: 336, Total: 407
INOVA Centromere Ab ELISA - Positive: 59, Negative: 348, Total: 407
Key results for method comparison:
Positive Percent Agreement: 93.2% (95% Cl 82.7% - 97.8%)
Negative Percent Agreement: 95.4% (95% CI 92.5% - 97.3%)
Overall Agreement: 95.1% (95% CI 92.4% - 96.9%)
Cross Reactivity: A total of 669 potentially co-incident antibody positive specimens selected from individuals suffering from other autoimmune or infectious diseases were tested for centromere antibodies using the ImmuLisa™ assay. Indeterminate samples were considered positive.
Number of positive samples from other conditions: 18 (2.7%) out of 669.
Precision: Precision was tested with positive speciment the range of the assay. Seven patients were run in duplicate, twice per day for 20 days (n=80 replicates per sample). Assays were run by two operators on two different sets of equipment.
Key results for Precision (Mean EU/ml, Total Imprecision SD and CV%):
S#1: Mean 8.5, SD 0.5, CV% 6.0
S#2: Mean 16.4, SD 1.1, CV% 7.0
S#3: Mean 20.4, SD 1.1, CV% 5.6
S#4: Mean 23.8, SD 1.1, CV% 4.6
S#5: Mean 49.0, SD 3.1, CV% 6.2
S#6: Mean 105.1, SD 4.0, CV% 3.8
S#7: Mean 150.6, SD 5.3, CV% 3.5
Reproducibility: Qualitative reproducibility was tested with 80 runs of samples. Samples were tested in duplicate twice per day for 20 days by two different operators / equipment sets.
Key results for Reproducibility: Assay results for the cutoff specimen produced 62.5% qualitative (positive) agreement. Assay results for the ~20% above cutoff speciment. All other speciment. All other specimens produced 100% qualitative agreement.
Limit of Detection: The limit of detection (LoD) was determined based on 60 replicates of the blank and 10 replicates each of 6 low-level (NHS) samples.
Key results for LoD: LDD was determined to be 3.9 EU/ml.
Linearity and Recovery: Linearty and recovery were tested by diluting positive specimens through the assay range in equidistant dilutions and comparing actual vs. expected results.
Key results for Linearity and Recovery: The linear range of the assay was determined be 3.9 (LoD) -160 EU/ml.
Slope (95% CI): 1.05 (0.97 to 1.13), 1.02 (0.95 to 1.10), 1.03 (0.95 to 1.11)
Y-intercept (95% CI): -0.67 (-2.88 to 1.53), -0.18 (-5.64 to 5.29), 1.42 (-7.15 to 9.98)
R2: 0.9942, 0.9947, 0.9842
% recovery: 92% to 116%, 93% to 104%, 87% to 102%
Hook effect was not demonstrated in dilution samples with theoretical levels of 2531.3 EU/ml for testing within OD range of the microplate reader (~3.500).
Clinical Tests: Sets of clinical samples were tested on the IMMCO Centromere ELISA.
Sample size: 124 IcSSc/CREST samples and 865 autoimmune and infectious disease controls.
Key results: Sensitivity was determined to be 53.2%. Specificity was determined to be 95.5%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 53.2%
Specificity: 95.5%
Positive Percent Agreement: 93.2% (95% Cl 82.7% - 97.8%)
Negative Percent Agreement: 95.4% (95% CI 92.5% - 97.3%)
Overall Agreement: 95.1% (95% CI 92.4% - 96.9%)
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.
INOVA QUANTA Lite™ Centromere ELISA
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.
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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).
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§ 866.5100 Antinuclear antibody immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles 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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
IMMCO Diagnostics Inc. Mr. Kevin Lawson Chief Regulatory Officer 60 Pineview Drive Buffalo, NY 14228
Re: K151559
Trade/Device Name: ImmuLisa™ Enhanced Centromere Antibody ELISA Regulation Number: 21 CFR §866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LJM, antinuclear antibody (enzyme-labeled), antigen, controls Dated: February 5, 2016 Received: February 5, 2016
Dear Mr. Lawson:
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 Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kelly Oliner - S
For
Leonthena R. Carrington, MBA, MS, MT(ASCP) Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K151559 |
|---|---|
| Device Name | ImmuLisa™ Enhanced Centromere Antibody ELISA |
| Indications for Use (Describe) | An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutanteous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings. |
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green dots on the left, followed by the company name in blue, with the word "DIAGNOSTICS" in green below. Underneath the company name is the text "A Trinity Biotech Company" in a smaller font.
510(k) Summary
| Submitter: | Immco Diagnostics, Inc. |
|---|---|
| Address: | 60 Pineview Dr., Buffalo, NY 14228 |
| Phone Number: | 716-691-0091 ext. 110 |
| Contact: | Kevin Lawson |
| Summary Prepared: | 3-6-2016 |
| Device Name: | ImmuLisa™ Enhanced Centromere Antibody ELISA |
| Common Name: | Centromere Antibody ELISA |
| Product Code: | LJM, Antinuclear Antibody (Enzyme-Labeled), Antigen, Control |
| Substantially Equivalent to: | INOVA QUANTA Lite™ Centromere ELISA |
General Description: Antinuclear antibodies (ANA) occur in sera of patients with various connective tissue disorders such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), systemic sclerosis / scleroderma (SSc), polymyositis and Siögren's syndrome. These ANA are directed against nucleding DNA, nucleohistone and various extractable nuclear antigens (ENA) such as RNP, Sm, SS-A (Ro), SS-B (La), Centromere, Scl-70 (topoisomerase I) and Jo-1.
The anti-centromere antibody produces a discrete speckled pattern in HEp-2 immunofluorescence assays, and has been observed in 38-64% of patients with the limited cutaneous systemic sclerosis (IcSSc) or CREST syndrome variant of systemic sclerosis or scleroderma. Centromere antibodies bind the kinetochore of mitotic chromosomes and the pre-kinetochore of interphase cells. Immunoblotting analysis indicates that centromere antibodies recognize at least six epitopes on three chromosomal proteins: CENP-A (17-19kD), CENP-B (80kD), and CENP-C (140kD). CENP-A and CENP-B have been cloned and while CENP-B is the primary autoantigen, it appears that assays incorporating both antigens produce results with greater sensitivity and more comparable to immunofluorescence.
This test is performed as a solid phase immunoassay. Microwells are coated with recombinant purified CENP-A centromere antigens. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the centromere antibodies are detected by adding an enzyme labeled anti-human lgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.
Intended Use: An enzyme linked immunoassay (EUSA) for the qualitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutaneous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.
Similarities and Differences: Both kits use recombinant CENP-A and CENP-B coated on 96 well plates to detect IgG Centromere antibody with HRP anti-human IgG conjugate and TMB substrate. The IMMCO kit utilizes a 5 point calibrator curve with a borderline/indeterminate range of 20-25EU/ml; while the INOVA kit uses a single low positive sample as a cutoff of 20 units with no borderline range.
Non-clinical Tests:
Method Comparison: Both kits were tested with well-characterized lcSSc / CREST subjects and disease controls.
| INOVA Centromere Ab ELISA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| IMMCO | ||||
| Centromere Ab | ||||
| ELISA | Positive | 55 | 16 | 71 |
| Negative | 4 | 332 | 336 | |
| Total | 59 | 348 | 407 |
60 Pineview Drive ● ● Buffalo, NY 14228-2120 ● ● USA Toll free (800) 537-8378 • tel. (716) 691-0091 • fax (716) 691-0466
www.immco.com
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Image /page/4/Picture/0 description: The image shows the logo for Immco Diagnostics, a Trinity Biotech Company. The logo features a cluster of blue and green circles on the left, followed by the company name "immco" in blue, with "DIAGNOSTICS" in green underneath. Below the company name is the text "A Trinity Biotech Company" in a smaller font size.
| Positive Percent Agreement: | 93.2% (95% Cl 82.7% - 97.8%) |
|---|---|
| Negative Percent Agreement: | 95.4% (95% CI 92.5% - 97.3%) |
| Overall Agreement: | 95.1% (95% CI 92.4% - 96.9%) |
Cross Reactivity:
A total of 669 potentially co-incident antibody positive specimens selected from individuals suffering from other autoimmune or infectious diseases were tested for centromere antibodies using the ImmuLisa™ assay. Indeterminate samples were considered positive.
| Condition | n | Centerome Ab Pos |
|---|---|---|
| Diffuse cutaneous scleroderma | 39 | 1 |
| Anti-phospholipid syndrome | 36 | 4 |
| Anti-phospholipid syndrome with SLE | 20 | 0 |
| Celiac Disease | 35 | 2 |
| Churg-Strauss syndrome | 27 | 0 |
| Crohn's disease | 25 | 0 |
| Granulomatosis with polyangitis | 27 | 0 |
| Graves' disease | 20 | 0 |
| Hashimoto's thyroiditis | 20 | 0 |
| Osteoarthritis | 20 | 0 |
| Polymyositis/Dermatomyositis | 30 | 1 |
| Rheumatoid Arthritis | 24 | 1 |
| Sjögren's Syndrome | 37 | 2 |
| Systemic Lupus Erythematosus | 92 | 1 |
| Thrombocytopenia | 15 | 2 |
| Ulcerative Colitis | 25 | 0 |
| Cytomegalovirus | 20 | 0 |
| Hepatitis C | 20 | 0 |
| Herpes simplex virus type 1 | 20 | 3 |
| Herpes simplex virus type 2 | 20 | 0 |
| Lyme disease | 20 | 0 |
| Mononucleosis | 20 | 1 |
| Rubella | 20 | 0 |
| Syphilis | 17 | 0 |
| Toxoplasmosis | 20 | 0 |
| Total | 669 | 18 (2.7%) |
Precision
Precision was tested with positive speciment the range of the assay. Seven patients were run in duplicate, twice per day for 20 days (n=80 replicates per sample). Assays were run by two operators on two different sets of equipment.
| S# | Mean
EU/ml | Total
Imprecision | | Between days | | Between
Operator | | Within run
(Repeatability) | |
|----|---------------|----------------------|-----|--------------|-----|---------------------|-----|-------------------------------|-----|
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 8.5 | 0.5 | 6.0 | 0.3 | 3.3 | 0.2 | 2.8 | 0.3 | 4.1 |
| 2 | 16.4 | 1.1 | 7.0 | 0.8 | 5.2 | 0.6 | 3.6 | 0.5 | 3.0 |
| 3 | 20.4 | 1.1 | 5.6 | 0.5 | 2.3 | 0.5 | 2.5 | 0.9 | 4.4 |
| 4 | 23.8 | 1.1 | 4.6 | 0.8 | 3.5 | 0.5 | 2.2 | 0.5 | 1.9 |
| 5 | 49.0 | 3.1 | 6.2 | 2.2 | 4.5 | 1.5 | 3.1 | 1.5 | 3.0 |
| 6 | 105.1 | 4.0 | 3.8 | 2.7 | 2.6 | 2.4 | 2.3 | 1.7 | 1.6 |
| 7 | 150.6 | 5.3 | 3.5 | 2.0 | 1.4 | 2.8 | 1.9 | 4.0 | 2.7 |
60 Pineview Drive ● USA Toll free (800) 537-8378 • tel. (716) 691-0091 • fax (716) 691-0466
www.immco.com
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Image /page/5/Picture/0 description: The image is a logo for Immco Diagnostics, a Trinity Biotech Company. The logo features a cluster of blue and green dots on the left side, followed by the word "immco" in blue, bold letters. Below "immco" is the word "DIAGNOSTICS" in green, and below that is the text "A Trinity Biotech Company" in a smaller font size.
Reproducibility
Qualitative reproducibility was tested with 80 runs of samples range, ~20% below cutoff, ~20% above cutoff, in the moderate positive range of the assay and near the qualitative analysis method. Samples were tested in duplicate twice per day for 20 days be two different operators / equipment sets. Assay results for the cutoff specimen produced 62.5% qualitative (positive) agreement. Assay results for the ~20% above cutoff speciment. All other speciment. All other specimens produced 100% qualitative agreement.
Limit of Detection
The limit of detection (LoD) was determined based on 60 replicates of the blank and 10 replicates each of 6 low-level (NHS) samples. LDD was determined to be 3.9 EU/ml.
Linearity and Recovery
Linearty and recovery were tested by diluting positive specimens through the assay range in equidistant dilutions and comparing actual vs. expected results. The linear range of the assay was determined be 3.9 (LoD) -160 EU/ml. Results are summarized below:
| Test
Range
(EU/ml) | Slope
(95% CI) | Y-intercept
(95% CI) | R2 | % recovery |
|--------------------------|---------------------|-------------------------|--------|-------------|
| 3.2 to 46.0 | 1.05 (0.97 to 1.13) | -0.67 (-2.88 to 1.53) | 0.9942 | 92% to 116% |
| 6.3 to 123.1 | 1.02 (0.95 to 1.10) | -0.18 (-5.64 to 5.29) | 0.9947 | 93% to 104% |
| 4.9 to 188.1 | 1.03 (0.95 to 1.11) | 1.42 (-7.15 to 9.98) | 0.9842 | 87% to 102% |
To assess hook effect, dilutions of high positive specimens with results above the 160 EU/ml measuring range were tested. Hook effect was not demonstrated in dilution samples with theoretical levels of 2531.3 EU/ml for testing within OD range of the microplate reader (~3.500).
Clinical Tests: Sets of clinical samples were tested on the IMMCO Centromere ELISA. By testing 124 IcSSc/CREST samples the sensitivity was determined to be 53.2%. By testing 865 autoimmune and infectious disease controls the specificity was determined to be 95.5%.
Kevin J. Lawson VP Regulatory Affairs
60 Pineview Drive Buffalo, NY 14228-2120 Toll free (800) 537-8378