(59 days)
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No
The summary describes a standard ELISA kit and an automated processor for performing the assay. There is no mention of AI or ML in the device description, intended use, or performance studies. The automated processor likely automates liquid handling and reading, not data interpretation using AI/ML.
No.
The device is for qualitative detection and quantitation of antibodies to aid in diagnosis, not to treat or prevent a disease.
Yes
The intended use explicitly states that the kit is "an aid in the diagnosis of thyroid autoimmune disease."
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and processes, not solely software. While it can be used with an automated processor (Mago Plus), the core device itself is a chemical assay kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease." This is a diagnostic purpose performed on a biological sample (serum) in vitro (outside the body).
- Device Description: The description confirms it's an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum." ELISA is a common laboratory technique used for in vitro diagnostic testing.
- Sample Type: The test is performed on "serum," which is a biological sample.
- Diagnostic Aid: The intended use states it's an "aid in the diagnosis," which is a key characteristic of an IVD.
The information provided clearly indicates that this device is designed to perform a diagnostic test on a biological sample outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated ETA processor.
Product codes (comma separated list FDA assigned to the subject device)
JZO
Device Description
The TG IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.
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)
A. Relative Sensitivity and Specificity
Frozen retrospective sera from two hundred twenty-seven parties were tested.
- Relative Sensitivity: 30/36 = 83.3% (95% CI: 67.2-93.0)
- Relative Specificity: 172/177 = 97.2% (95% CI: 93.5-99.1)
- Overall Agreement: 202/213 = 94.8% (95% CI: 90.9-97.4)
B. Clinical Sensitivity and Specificity Using Characterized Sera
A total of 207 frozen retrospective, clinically characterized sera were assayed.
- Clinical Specificity (Normals): 171/175 = 97.7% (95% CI: 94.3-99.4)
- Clinical Sensitivity (Grave's Disease): 5/13 = 38.5% (95% CI: 13.9-68.4)
- Clinical Sensitivity (Hashimoto's Disease): 9/14 = 64.3% (95% CI: 35.1-87.2)
C. Precision of the Is-anti-TG IgC Test Kit
Four positive and two negative sera were assayed ten times in three different runs at two different sites.
- Site #1 Interassay Precision (CV%):
- SERUM A (POS): 12.01
- SERUM B (POS): 10.95
- SERUM C (POS): 15.86
- SERUM D (POS): 12.72
- SERUM E (NEG): 35.59
- SERUM F (NEG): 98.47
- Site #2 Interassay Precision (CV%):
- SERUM A (POS): 7.72
- SERUM B (POS): 10.45
- SERUM C (POS): 7.98
- SERUM D (POS): 11.70
- SERUM E (NEG): 26.15
- SERUM F (NEG): 87.64
D. Correlation of Manual and MAGO Plus Results
The results of 91 serum samples showed good correlation with a Pearson Correlation Coefficient of 0.988.
E. MAGO Plus Precision
The precision of the Is-anti-TC IgCTest Kit was determined by assaying six sera in three different runs using the MAGO Plus.
- Site #2 Interassay Precision (CV%):
- SERUM A (POS): 13.61
- SERUM B (POS): 9.81
- SERUM C (POS): 10.30
- SERUM D (POS): 11.95
- SERUM E (NEG): 36.70
- SERUM F (NEG): 43.34
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity, Relative Specificity, Overall Agreement, Clinical Sensitivity, Clinical Specificity, Precision (CV%), Pearson Correlation Coefficient.
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.
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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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§ 866.5870 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).
0
510k Summary of Safety and Effectiveness 7 1998 DEC
is summary of 510(k) safety and effectiveness information is heing submitted in accordance with the equirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is :
Applicant Information:
| Contact Person: | Norman Jenkins |
|---|---|
| PhoneNumber. | 410-995-0450 |
| Fax Number. | 410-995-0448 |
Device Information:
| Trade Name: | anti-TG IgG ELISA Kit |
|---|---|
| Common Name: | Thyroglobulin IgG EIA Test |
| Classification Name; | Thyroglobulin Serological Reagent |
Juivalent Device:
ELIAS TG Kit
Device Description: The TG IgG FI.ISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.
TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the Intended Use: The & Intended Use: The & TO 1gO Kir Is antibodies against the Thyroglobulin antigen in senum all on in qualitative detection and quantitiation of antiboones against of the manually or in
the diagnosis of thyroid autoimmune disease . The test can be performed either manually or conjunction with the Mago Plus automated EIA processor.
Principle of Procedure:
T G antigen is bound to microwells. Diluted patient sera, Calibrators and controls are placed inthody complexes I G antigen is bound to microwens. Will bind to the antigen forming antigen antibody complexes lebel antibi incubated. Anti-113 IgGranning and washing. Conjugate (horseradish peroxidase-labeled anti-human
Residual sample is eliminated by aspirating and washing. Conjugate consection Resident sample is eliminated by aspirating and was and the spherests as enverted is opported to an igit) is added and will incubated. In the presence of bound enzymently substrate is converted to an end Stostiale is their added and medical in the problementically at 450 mm (reference 600-630
Touce. The adsorbance of this chu produce can over of IgG antibodies to TG present in the sample.
1
Performance Characteristics
A. Relative Sensitivity and Specificity
Frozen retrospective sera from two handed twenty-seven parties of this lesting of this testing, the resting, the resting Frozen retrospective sera from lwo lundred we the sults of this testing, the relative a commercially available ELISA KITTOF FO untiloodies: Discussion in Table 2:
TABLE 2
| Is-anti-TG IgG | |||
|---|---|---|---|
| POSITIVE | * EQUIVOCAL | NEGATIVE | |
| POSITIVE | 30 | 1 | 6** |
| EQUIVOCAL* | 3 | 0 | 6 |
| NEGATIVE | 5 | 4 | 172 |
| Relative Sensitivity | |||
| Relative Specificity | |||
| Overall Agreement | $30/36 = 83.3%$ | ||
| $172/177 = 97.2%$ | |||
| $202/213 = 94.8%$ | 95% CI | ||
| 67.2-93.0 | |||
| 93.5-99.1 | |||
| 90.9-97.4 |
Other ELISA
- Equivocal results were excluded from calculations
** Five sera were from a normal population.
NOTE : Please be advised that Telative refers to the assay's results to that of as that of as innihances . No indusent can to NOTE: Prease be attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict discase.
B. Clinical Sensitivity and Specificity Using Characterized Sera
. Ontal of 207 frozen retrospective, clinically characterized sera were assayed using the Is-anti-TG Test Kit. The results obtained are shown in Table 3.
| Patient Group: | Positive | Equivocal* | Negative | Total | |
|---|---|---|---|---|---|
| Normals | 4 | 171 | 176 | ||
| Grave's Disease | ਨ | 2 | ୦୯ | । રે | |
| Hashimoto's Disease | 9 | 2 | 5 | । G | |
| Clinical Specificity: | 95% CI | ||||
| Normals | ::: | 171175=97.7% | 94.3-99.4 | ||
| Clinical Sensitivity: | 95% CI | ||||
| Grave's Disease | 5/13 = 38.5% | ||||
| ============================================================================================================================================================================== | 13.9-68.4 | ||||
| Hashimoto's Disease | 9/14 = 64.3% | ||||
| ============================================================================================================================================================================== | 35.1-87.2 |
TABLE 3
- Equivocal results were excluded from calculations
2
tive sera were assayed ten times
C. Precision of the Is-anti-TC IgC Test Kit, four positive and wo negative scra wereassayd con tines is shown i To decemine the precision of the Is-anti-TG IgO Test Kit, four positive sen worked in each site is shown in
The in thee different runs at two different sites. The interassay
Tables 4 and 5.
ssay and Interassay Precision
| TABLE 4: Site #1- Intra-Assay and Interassay | ||||||||
|---|---|---|---|---|---|---|---|---|
| SERUM | INTRA-ASSAY RUN 1 | |||||||
| MEAN | ||||||||
| IU/ml | CV% | INTRA-ASSAY RUN 2 | ||||||
| MEAN | ||||||||
| IU/ml | CV% | INTRA-ASSAY RUN 3 | ||||||
| MEAN | ||||||||
| IU/ml | CV% | INTERASSAY | ||||||
| MEAN | ||||||||
| IU/ml | CV% | |||||||
| A (POS) | 204.8 | 13.49 | 193.5 | 11.35 | 195.1 | 11.35 | 197.8 | 12.01 |
| B (POS) | 449.8 | 9.94 | 432.8 | 12.52 | 475.0 | 9.35 | 452.6 | 10.95 |
| C (POS) | 165.0 | 13.95 | 148.5 | 18.51 | 160.7 | 14.94 | 158.1 | 15.86 |
| D (POS) | 86.2 | 10.07 | 72.8 | 11.09 | 85.9 | 10.20 | 81.6 | 12.72 |
| E (NEG) | 9.1 | 42.20 | 7.2 | 39.26 | 10.5 | 17.79 | 9.0 | 35.59 |
| F (NEG) | 1.8 | 61.85 | 0.1 | 316.23 | 1.5 | 56.43 | 1.1 | 98.47 |
te #2- Intra-Assay and Interassay Precision i
| TABLE 5: Site #2 Intra Assay | ||||||||
|---|---|---|---|---|---|---|---|---|
| SERUM | INTRA-ASSAY RUN 1 | |||||||
| MEAN | ||||||||
| IU/ml | CV% | INTRA-ASSAY RUN 2 | ||||||
| MEAN | ||||||||
| IU/ml | CV% | INTRA-ASSAY RUN 3 | ||||||
| MEAN | ||||||||
| IU/ml | CV% | INTERASSAY | ||||||
| MEAN | ||||||||
| IU/ml | CV% | |||||||
| A (POS) | 181.38 | 6.65 | 187.53 | 5.13 | 172.40 | 9.38 | 180.38 | 7.72 |
| B (POS) | 343.06 | 5.96 | 339.81 | 12.06 | 313.64 | 11.09 | 332.17 | 10.45 |
| C (POS) | 126.43 | 2.48 | 130.80 | 0.81 | 122.80 | 10.11 | 126.19 | 7.98 |
| D (POS) | 71.04 | 5.56 | 69.59 | 8.96 | 62.52 | 16.11 | 67.72 | 11.70 |
| E (NEG) | 13.30 | 16.24 | 14.53 | 11.28 | 8.32 | 9.36 | 12.05 | 26.15 |
| F (NEG) | 3.30 | 49.09 | 6.60 | 62.90 | 1.61 | 83.20 | 3.87 | 87.64 |
D. Correlation of Manual and MAGO Plus Results
D. Correlation of Manual and MACO Frida 1100 million in the manual use. In capiralence of
The Is-anti-TC IgC Test Kit has been developed for automation were platical A The Is-anti-TC IgG Test Kit his been developed for annount tost 10 onlined. And 10 common
the manual and MAO Plus procedures, the results of Discrums in Shown in Figure 3. Th The Is-Mitt I O Igo Tex receives, the results of 91serum samples described world be responsible in the more in Figure ... The data
the data and regression line of the obtainc scattergram and regression line of the results obtained with the more of 0.988.
Indicate good correlation with a Pearson Correlation Coefficient of 0.988.
Indicate good corre
Image /page/2/Figure/10 description: This image is a scatter plot comparing MAGO Plus IU/ML values to MANUAL IU/ML values. The x-axis represents MANUAL IU/ML values, ranging from 0 to 900, while the y-axis represents MAGO Plus IU/ML values, ranging from 0 to 1200. The data points are clustered around a straight line, indicating a strong positive correlation between the two sets of values. The correlation coefficient, r, is given as 0.988.
Image /page/2/Figure/11 description: This image contains the text 'FIGURE 3 : Correlation of Manual vs MAGO Plus Results'. The text appears to be a figure label or title, indicating that the image is likely a figure from a research paper or report. The figure likely shows the correlation between manual results and MAGO Plus results. The image is cropped and only contains the text.
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E. MAGO Plus Precision
E. MAGO Plus Precision
The precision of the Is-anti-TC IgCTest Kit when performed on the intra-and interassay precision The precision of the Is-anti-TCT IgC Test Kit when performed on the intribution interessay precision
med by assuying six secatent in three different runs. Table 6 shows the i obtained using the MAGO Plus.
| TABLE 6: Site #2 | ||||||||
|---|---|---|---|---|---|---|---|---|
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | ||||
| MEAN IU/ml | CV% | MEAN IU/ml | CV% | MEAN IU/ml | CV% | MEAN IU/ml | CV% | |
| A (POS) | 216.96 | 10.55 | 268.01 | 9.07 | 264.69 | 10.67 | 249.89 | 13.61 |
| B (POS) | 538.50 | 9.58 | 541.51 | 11.08 | 588.90 | 6.72 | 556.30 | 9.81 |
| C (POS) | 191.12 | 7.30 | 209.07 | 10.78 | 207.64 | 10.06 | 203.48 | 10.30 |
| D (POS) | 97.10 | 8.28 | 113.77 | 8.64 | 114.53 | 11.19 | 108.47 | 11.95 |
| E (NEG) | 17.40 | 21.73 | 10.41 | 29.34 | 12.34 | 40.64 | 13.38 | 36.70 |
| F (NEG) | 8.82 | 32.67 | 6.54 | 42.03 | 6.13 | 52.93 | 7.16 | 43.34 |
TABLE 6 : Site #2- Intra-Assay and Interassay Precision - MAGO Plus
- MAGO Plus
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.
DEC 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Norman Jenkins President Columbia Bioscience, Inc. 8775 M Centre Park Drive, #559 Columbia, Maryland 21045
K983553 Re : K983553
Trade Name: Is Anti-TG IgG ELISA Test System Regulatory Class: II Product Code: Jzo Dated: October 8, 1998 Received: October 9, 1998
Dear Mr. Jenkins:
This letter corrects our substantially equivalent letter of This letter corrects our subbedies of the corrected Indications for Use 1997 regarding the Section 510 (k) notification of statement. statement. We have reviewed your book above and we have determined intent to market the device features a our the indications for use
the device is substantially equivalent (for the indicate devices the device is subscantlarly cquiries were ed predicate devices
stated in the enclosure) to legally marketed predicate the ena stated in the encrosure) co regary marker and 28, 1976, the enactment marketed in interstate commerce price of to devices that have been date of the Medical Device Amendates, of the Federal Food,
reclassified in accordance with the provisions market the device reclassified in accordance with the particles on the device, subject to the general controls provisions of the Act. The general controls to the qeneral concrols provirements tor annual controls provisions of che sices, good manufacturing practice, registration, firsting or academing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such controlor of olabora - Existing major regulations affecting your device of aan be found in the Code of Federal Requlations, Title 21, Parts 800 can be reasubstantially equivalent determination assumes compliance e with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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Page I of I
Job 960
K983553 510(k) Number: Not Known
Device Name: & TG IgG ELISA
Indications For Use: The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed cither manually or in conjunction with the Mago Plus automated ETA processor.
Peter 2. Malin
(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number. K983553
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 3 ・ ・ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)