ANTI-TG IGG ELISA TEST SYSTEM

{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<br>Relative Specificity<br>Overall Agreement | | $30/36 = 83.3%$<br>$172/177 = 97.2%$<br>$202/213 = 94.8%$ | 95% CI<br>67.2-93.0<br>93.5-99.1<br>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%<br>============================================================================================================================================================================== | | 13.9-68.4 | | | | Hashimoto's Disease | 9/14 = 64.3%<br>============================================================================================================================================================================== | | 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<br>MEAN<br>IU/ml | CV% | INTRA-ASSAY RUN 2<br>MEAN<br>IU/ml | CV% | INTRA-ASSAY RUN 3<br>MEAN<br>IU/ml | CV% | INTERASSAY<br>MEAN<br>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<br>MEAN<br>IU/ml | CV% | INTRA-ASSAY RUN 2<br>MEAN<br>IU/ml | CV% | INTRA-ASSAY RUN 3<br>MEAN<br>IU/ml | CV% | INTERASSAY<br>MEAN<br>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. {3}------------------------------------------------ # 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ ### 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 {6}------------------------------------------------ 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)