NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521

{0}------------------------------------------------ #### K982866 11.0 510(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. #### not known 510(k) Number: ## 1. Name of Submitter, Contact Person and Date Summary Prepared: Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 Phone: 949-240-5260 Fax: 949-240-5313 Contact Person: Jimmy Wong Date Prepared: July 31, 1998 #### 2. Device Name | Trade/Proprietary Name: | Nichols Advantage™ Chemiluminescence Thyroid<br>Peroxidase Autoantibodies Immunoassay | |-------------------------|---------------------------------------------------------------------------------------| | Common/Usual Name: | Anti-TPO Assay | | Classification Name: | Thyroid, Autoantibody Immunological Test System | #### 3. Predicate Device: substantial equivalence the Nichols Institute Diagnostics We claim to Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay (K931311, Cleared 5/14/93). #### 4. Device Description: The Nichols Advantage™ Anti-TPO is a two-site chemiluminescence assay for use with the Nichols Advantage™ Specialty System {1}------------------------------------------------ ## 5. Intended Use The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease. ### 6. Comparison to predicate device: The Nichols Advantage™ Anti-TPO is substantially equivalent to other products in commercial distribution for similar use. Most notably, it is substantially equivalent to the NID Chemi Anti-TPO Immunoassay kit. The following tables compare the Nichols Advantage Anti-TPO with the predicate device. NID Chemi Anti-TPO Immunoassay kit. ### Similarities: - Intended Use: For the quantitative determination of Anti-TPO in human serum. ● - Both assays use recombinant TPO to bind specific Anti-TPO autoantibodies. ● - Both assays use human serum for the test sample. . - The sensitivity of both assays is sufficient to measure Anti-TPO autoantibody levels . found in patients with autoimmune disease. | Feature | Nichols Advantage™<br>Anti-TPO | Nichols Institute<br>Diagnostics<br>Chemiluminescence<br>Anti-TPO | |-------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Sample Size | 15 uL of sample diluted with<br>435 uL of Assay Diluent<br>(1:30 dilution).<br>65 uL of diluted sample<br>assayed. | 50 uL of sample diluted with<br>1000 uL of Assay Diluent<br>(1:21 dilution).<br>100 uL of diluted sample<br>assayed. | | Calibration | Two point calibration every two<br>weeks (maximum) of stored<br>working calibration curve; or<br>when controls out of range. | Full calibration curve with<br>every run. | | Solid Phase | Streptavidin-coated magnetic<br>particles. Streptavidin-biotin<br>separation technology. | 6 mm bead | | Incubation | 30 minutes at 37°C | 2 hours at room temperature | | Sensitivity | 0.5 IU/mL in serum | 0.2 IU/mL in serum | #### Differences: {2}------------------------------------------------ # Performance Characteristics: | FEATURE | Nichols AdvantageTM<br>Chemiluminescence Anti-TPO | | | Nichols Institute Diagnostics<br>Chemiluminescence Anti-TPO | | | |--------------------------------------|---------------------------------------------------|----------------------------------------------------|------|-------------------------------------------------------------|----|------| | | Mean<br>(IU/mL) | n | %CV | Mean<br>(IU/mL) | n | %CV | | Intra-Assay | 3.4 | 20 | 5.4 | 2.4 | 21 | 10.7 | | | 8.6 | 20 | 5.0 | 77 | 22 | 7.5 | | | 52.9 | 20 | 3.9 | | | | | Inter-Assay | Mean<br>(IU/mL) | n | %CV | Mean<br>(IU/mL) | n | %CV | | | 3.4 | 20 | 14.3 | 9.6 | 23 | 9.7 | | | 8.5 | 20 | 9.6 | 30 | 10 | 9.1 | | | 54.0 | 20 | 9.1 | | | | | Recovery | | 94 - 107% | | 92 - 113% | | | | Parallelism | 88 - 117% | | | Not Done | | | | High Dose Hook Effect | | > 4,000 IU/mL | | Not Done | | | | Specificity and<br>Cross-Reactivity: | | | | | | | | Anti-Thyroglobulin | | Undetectable | | Not Done | | | | Thyroglobulin | | Undetectable | | Not Done | | | | Method Comparison | | Preliminary Reference Range:<br>Normal < 2.0 IU/mL | | | | | | Range of Results | | 0.02 - 1548 | | 0.00 - 1783 | | | | Binomial Test Statistic | | P(X) = 0.0611 | | | | | | Relative Sensitivity | | 94.1% | | | | | | Relative Specificity | | 94.2% | | | | | | Agreement | 94.1% | | | | | | {3}------------------------------------------------ 2098 Gaither Road Rockville MD 20850 Food and Drug Administration Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle. OCT 1 6 1998 Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675-4703 Re : K982866 Nichols Advantage™ Chemiluminescence Thyroid Trade Name: Peroxidase Autoantibodies Immunoassay Regulatory Class: II Product Code: JZO Dated: July 31,1998 Received: August 14, 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 your device can be found in the Code of Federal Requlations, 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 requlation (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 requlatory 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 4.0 #### INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K982866 Device Name: Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay Indications For Use: The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an 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) - | Prescription Use <span style="font-size: 2em;">✓</span> | OR | Over-The-Counter Use | |---------------------------------------------------------|----|--------------------------| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number ________