NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY

{0}------------------------------------------------ JAN 26 1999 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### 510(k) Number: K983992 # 1. Name of Submitter, Contact Person and Date Summary Prepared: Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675 Phone: 714-240-52690 Fax: 714-240-5313 Contact Person: Jimmy Wong Date Prepared: January 21, 1999 ### 2. Device Name | Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Thyroglobulin<br>Autoantibodies Immunoassay | |-------------------------|----------------------------------------------------------------------------------| | Common/Usual Name: | Anti-Tg Assay | | Classification Name: | Thyroid, Autoantibody Immunological Test System | ### 3. Predicate Device: Nichols Institute Diagnostics substantial equivalence to the We claim Chemiluminescence Thyroglobulin Autoantibodies assay. ### 4. Device Description: TgAb chemiluminescence immunoassay is a two-site The Nichols Advantage® immunometric method based on binding anti-thyroglobulin antibodies in human serum to human thyroglobulin (Tg). Total duration of assay is 31.5 minutes at 37°C. ### 5. Intended Use The Nichols Advantage® Chemiluminescence Thyroglobulin Autoantibodies Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of thyroglobulin autoantibodies (TgAb) in human serum. This assay is intended to aid in the diagnosis and assessment of patients with autoimmune thyroid disease. {1}------------------------------------------------ ## 6. Comparison to predicate device: The Nichols Advantage® Thyroglobulin Autoantibodies Immunoassay is substantially equivalent to other products in commercial distribution for similar use. Most notably it is substantially equivalent to the Nichols Institute Diagnostics Chemiluminescence Thyroglobulin Autoantibodies assay. The following tables compare the new device with the predicate device. ### Similarities: - Intended Use: For the quantitative determination of TgAb in human sera. . - Both assays use highly purified thyroglobulin of human origin. . - Both assays use human serum for the test sample. . - The sensitivity of both assays is sufficient to measure TgAb levels found in patients . with autoimmune thyroid disease. - Pooled sera with high concentrations of TgAb are used as standards in the both ● assays. The standard is calibrated to WHO 1st IRP 65/93. - Both methods are based on acridinium conjugated Tg and biotin coupled Tg to . produce a sandwich complex with the patient's TgAb. #### Differences: | Feature | Nichols Advantage TgAb | Predicate Device | |------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Sample Size | 20 uL<br>1:15 dilution with assay diluent.<br>60 uL of the diluted sample is assayed. | 100 uL<br>1:10 dilution with assay dilutent.<br>100 uL of the diluted sample is assayed. | | Calibration | Two-point calibration stable for<br>one week from working<br>calibration curve, or when<br>controls are out of range. | Full calibration curve with every<br>run. | | Assay Set-up | Automated | Manual | | Solid Phase | Streptavidin coated magnetic<br>particles. Streptavidin-biotin<br>separation technology. | 6 mm bead | | Incubation | 31.5 minutes at 37C | 2 hours at room temperature<br>using a rotator. | | Reportable Range | Approx. 0.3-90 IU/mL | Approx. 0.2-60 IU/mL. | {2}------------------------------------------------ , # Performance Characteristics: എയാറ്റ് സംസ്ഥാപനം ചെയ്തു. അവലംബം | Feature | Nichols Advantage TgAb | | | Predicate Device | | | |---------------------------------|-----------------------------|----|------|-----------------------------|----|------| | Precision | Mean<br>(UI/mL) | N | %CV | Mean<br>(UI/mL) | N | %CV | | Intra-Assay | 3.6 | 20 | 7.2 | 1.9 | 20 | 8.7 | | | 13.8 | 20 | 6.1 | 41 | 20 | 5.9 | | | 60.2 | 20 | 5.8 | | | | | Inter-Assay | 4.0 | 20 | 12.9 | 3.1 | 15 | 14.2 | | | 13.7 | 20 | 6.1 | 36 | 22 | 7.7 | | | 55.0 | 20 | 6.8 | | | | | Recovery | 94 - 113% | | | 83 - 111% | | | | High Dose Hook | 4,000 IU/mL | | | Not Done | | | | Specificity and Crossreactivity | | | | | | | | Recombinant hTPO @ 200 mg/L | 95% recovery | | | Not Done | | | | TPO Ab @ 2000 IU/mL | 91% recovery | | | Not Done | | | | Method Comparison: | | | | | | | | Range of results | Undetectable to 2,089 IU/mL | | | Undetectable to 2,190 IU/mL | | | | Binomial Test Statistic | P(X) = 0.25 | | | | | | | Relative Sensitivity | 100% | | | | | | | Relative Specificity | 98.3% | | | | | | | Agreement | 98.6% | | | | | | | Reference Range | Up to 1 IU/mL | | | Up to 2 IU/mL | | | {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows a black and white emblem of the U.S. Department of Health & Human Services. The emblem features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the eagle. The text is oriented vertically along the left side of the emblem. JAN 26 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675 Re: K983992 Trade Name: Nichols Advantage® Chemiluminescence Thyroglobulin Autoantibodies Immunoassay Regulatory Class: II Product Code: JZO Dated: November 6, 1998 Received: November 9, 1998 # Dear Mr. Wong: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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. {4}------------------------------------------------ ### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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 Sutman 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 {5}------------------------------------------------ # INDICATIONS FOR USE STATEMENT # 510(k) Number (if known): K983992 # Device Name: Nichols Advantage® Chemiluminescence Thyroglobulin Autoantibodies Immunoassay # Indications For Use: Chemiluminescence Thyroglobulin Autoantibodies Advantage® The Nichols Immunoassay is designed for use with the Nichols Advantage® Specialty System for the minitative determination of thyroglobulin autoantibodies (TgAb) in human serum. This assay is intended to aid in the diagnosis and assessment of patients with autoimmune thyroid disease. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of Clinical Laboratory Devices | K983992 | | 510(k) Number | | | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|--------------------------| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |