SERAQUEST ANTI-DSDNA

{0}------------------------------------------------ APPENDIX 3. (revised 4/10/98) APR 2 4 1998 510(k) SUMMARY K980391 | Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL 33181 | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Registration No. | 1061839 | | Contact Person: | Robert A. Cort, V.P. , Quality Assurance | | Telephone: | (305) 948-8788 | | Telefax: | (305) 948-4876 | | Manufacturing Site: | Same as above | | Device: | SeraQuest® Anti-dsDNA | | Device Name: | Anti-nuclear antibody immunological test system (21CFR § 866.5100)<br>Systemic lupus erythematosus immunological test system<br>(21CFR § 866.5620) | Tevice Classification: Class II (performance standards) # Description: The SeraQuest Anti-dsDNA test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against dsDNA, in human serum. The Calibrators in the SeraQuest Anti-dsDNA test set have been assigned IU/ml values which are traceable to the WHO First International Standard for Anti-Double-Stranded DNA, Wo-80, and Index values which based on an in-house standard anti-dsDNA serum. Test results are reported as IU/ml or as Index values. # Principle: Diluted samples are incubated in wells coated with dsDNA antibodies against ds DNA (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to DSDNA are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm. {1}------------------------------------------------ #### ntended Use: ( For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to dsDNA in human serum by enzyme immunoassay, as an aid in the diagnosis systemic lupus erythematosus (SLE). For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only. #### Predicate Device: The SeraQuest Anti-dsDNA test is substantially equivalent in intended use and performance, to the Shield DIASTAT Anti-dsDNA kit, Shield Diagnostics, Dundee, UK. #### Summary of technological characteristics: | Characteristic | SeraQuest Anti-dsDNA | Shield Anti-dsDNA | |--------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------| | Description: | Enzyme Immunoassay | Enzyme Immunoassay | | Intended Use: | The detection of IgG<br>antibodies against dsDNA<br>in human serum. | The detection of IgG & IgM<br>antibodies against dsDNA<br>in human serum. | | Solid Phase: | Plastic Microwell | Plastic Microwell | | Antigen: | Calf Thymus DNA | Calf Thymus DNA | | Number of Incubation Periods: | Three | Three | | Sample Dilution: | 1:50 | 1:100 | | Sample Incubation<br>Duration: | 30 minutes | 60 minutes | | Incubation Temperature: | Room temperature | Room temperature | | Ezyme-labeled Conjugate: | | | | Antibody | Goat anti-human IgG | Goat anti-human IgG & IgM | | Enzyme | Alkaline phosphatase | Alkaline phosphatase | | Conjugate Volume: | 100 µl | 100 µl | | Conjugate Incubation Duration: | 30 minutes | 30 minutes | | Substrate: | p-Nitrophenyl<br>phosphate | phenolphthalein<br>monophosphate | {2}------------------------------------------------ | Subtrate Volume: | 100 µl | 100 µl | |-----------------------------------|------------------------------|------------------------------| | Substrate Incubation<br>Duration: | 30 minutes | 30 minutes | | Stop Reagent: | 0.5 M Trisodium<br>phosphate | Sodium Hydroxide | | Stop Reagent Volume: | 100 µl | 100 µl | | Readout: | Spectrophotometric<br>405 nm | Spectrophotometric<br>550 nm | ### Summary of Clinical Testing: Of 215 specimens tested, 64 were positive, 126 were negative and 1 was equivocal in both the SeraQuest and Shield tests (Table 1 below). Of the 25 remaining specimens were equivocal in the SeraQuest test and of these, 2 were positive and 3 were negative by the Shield test: 11 specimens were equivocal by the Shield test and of these, 4 were positive and 7 were negative by the SeraQuest test; 3 specimens which were positive by the SeraQuest test were negative by the Shield test, and 5 specimens which were positive by the Shield test were negative by the SeraQuest test. ### ГАВLE 1. ## RESULTS OF SeraQuest ANTI-dsDNA ASSAYS AND SHIELD DIASTAT ANTI-dsDNA ASSAYS OF 215 SERUM SPECIMENS, PERFORMED AT QUEST INTERNATIONAL, INC. MIAMI, FL. | SHIELD<br>DIASTAT<br>ANTI-dsDNA | | SeraQuest ANTI-dsDNA | | | | % | 95% CIv | |---------------------------------|----------|----------------------|----------|-----------------------|------|--------------|---------| | | Positive | Equivocal | Negative | | | | | | Positive | 64 {36} | 2 | 5 | Relative sensitivity* | 92.8 | 86.6 to 98.9 | | | Equivocal | 4 {2} | 1 | 7 {1} | | | | | | Negative | 3 {1} | 3 {2} | 126 {8} | Relative specificity* | 97.7 | 95.1 to 100 | | | Overall agreement* | | | | | 96.0 | 93.2 to 98.7 | | { } Number of patients with clinically diagnosed SLE. * Exeluding equivasel results - Excluding equivocal results. Calculated by the normal method. {3}------------------------------------------------ APR 2 4 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181 Re : K980391/S1 Trade Name: SeraQuest® Anti-dsDNA Requlatory Class: II Product Code: LRM Dated: April 14, 1998 Received: April 17, 1998 Dear Mr. Cort: 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation 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 Requlations. {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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Putman 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}------------------------------------------------ Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 137 #### APPENDIX 6 (revised 4/10/98) Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): K980391 Device Name: _ SeraQuest Anti-dsDNA Indications For Use: - For in vitro diagnostic use only. 1. - For the qualitative, semi-quantitative and quantitative detection of IgG antibodies 2. to dsDNA in human serum by enzyme immunoassay. - For use as an aid in the diagnosis of systemic lupus erythematosus (SLE). 3. ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ - For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) [Prescription Use](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/prescription-labeling) (Per 21 CFR 801.109) OR [Over-The-Counter Use](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/over-counter-otc-devices) (Optional Format 1-2-96)