SERAQUEST TOXOPLASMA IGM

{0}------------------------------------------------ Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. Jorge APPENDIX 5. 510(k) SUMMARY | Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL 33181 | |------------------------|-------------------------------------------------------------------------------| | Date prepared: | May 1, 1997 | | Contact person: | Robert A. Cort, President | | Telephone: | (305) 948-8788 | | Telefax: | (305) 948-4876 | | Device: | SeraQuest Toxoplasma IgM | | Device Classification: | Class II (performance standards) | | Device Name: | Toxoplasma serological reagents (21CFR § 866.3780) | ## Description: The SeraQuest Toxoplasma IdM test is a solid-phase enzyme immunoassay (ElA), which is erformed in microwells, at room temperature, in three thirty minute incubations. It has been seveloped to detect IdM antibodies which are directed against Toxoplasma gondii, in human serum. The Calibrators in the SeraQuest Toxoplasma IgM test set have been assigned Index values based on an in-house standard, and International Units (IU/ml) based on the WHO Anti-toxoplasma Serum, Human, (3rd international standard preparation). Test results are reported as Index values, or IU/ml. # Principle: Diluted samples are incubated in wells coated with Toxoplasma gondii antibodies directed against toxoplasma (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to Toxoplasma are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow endproduct which is read photometrically at 405 nm. ## Intended Use: For the quantitative, semi-quantitative and qualitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with the anti-Toxoplasma gondi IgM antibody assay, must be accompanied by a anti- {1}------------------------------------------------ # APPENDIX 5. >xoplasma gondi IgG antibody assav. For manual use, or for use with the HyPrep System Plus. ithis assay has not been cleared / approved by the FDA for blood / plasma donor screening. For In Vitro Diagnostic Use Only. Please see Indications for Use form, Appendix 11. ## Predicate device: The SeraQuest Toxoplasma IgM test has been shown to be substantially equivalent to the Toxoplasma IgM Clin-ELISA™ kit, INCSTAR Corporation, Stillwater Minnesota. ### Summary of technological characteristics: | Characteristic | SeraQuest Toxoplasma IgM | INCSTAR Toxo IgM Clin-ELISA™ | |-----------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Description: | Enzyme Immunoassay | Enzyme Immunoassay | | Intended Use: | The detection of IgM<br>antibodies against Toxoplasma<br>gondii in human serum. | The detection of IgM<br>antibodies against Toxoplasma<br>gondii in human serum. | | Antigen Strain | RH | RH | | Solid Phase: | Plastic Microwell | Plastic Microwell | | 'umber of Incubation Periods: | Three | Three | | Sample Dilution: | 1:26 | 1:51 | | Sample Volume: | 100 μl | 200 μl | | Sample Pretreatment<br>Duration: | None | 30 minutes | | Sample Incubation<br>Duration: | 30 minutes | 30 minutes | | Incubation Temperature: | Room temperature | Room temperature | | Ezyme-labeled Conjugate: | | | | Antibody | Goat anti-human IgM | Goat or Sheep anti-human IgM | | Enzyme | Alkaline phosphatase | Alkaline phosphatase | | Conjugate Volume: | 100 μl | 200 μl | | Conjugate Incubation<br>Duration: | 30 minutes | 30 minutes | | Substrate: | p-Nitrophenyl phosphate | p-Nitrophenyl phosphate | | Substrate Volume: | 100 μl | 200 μl | | Substrate Incubation Duration: | 30 minutes | 45 minutes | | Stop Reagent: | 0.5 M Trisodium phosphate | 3 N Sodium Hydroxide | | Stop Reagent Volume: | 100 μl | 50 μl | | Readout: | Spectrophotometric 405 nm | Spectrophotometric 405 nm | | Summary of Clinical Testing: | | | {2}------------------------------------------------ # APPENDIX 5. ## Experimental Procedure One hundred and twenty-eight archival serum specimens including: 24 specimens from normal, asymptomatic donors, 38 specimens from women being tested prenatally for antibodies to toxoplasma and 16 specimens reported to be positive for IgM antibodies to toxoplasma which were obtained from serum brokers, and 50 specimens from acute toxoplasma infections, were tested at 'uest International, Inc., concurrently by the SeraQuest Toxoplasma IgM test and the INCSTAR . oxoplasma IgM Clin-ELISA™ test. The assays were performed and interpreted according to the manufacturers package inserts. Specimens giving discordant results were tested with a second legally marketed device, along with a representative number of positive and negative samples which gave concordant results by both test methods. #### Results and Conclusion Of the 128 specimens tested, 51 were positive, and 55 were negative in both the SeraQuest and Incstar tests (please see Table 1). Of the 22 remaining specimens which were negative by the Incstar test were positive by the SeraQuest test, and 10 specimens which were positive by the Incstar test were negative in the SeraQuest test. The remaining 8 specimens gave equivocal results in one or both of the assays being compared. Of 5 specimens which were equivocal in the SeraQuest assay 4 were positive and 1 was negative in the Incstar assay, and of 3 specimens which were equivocal in the Incstar assay. 1 was positive and 2 were negative by the SeraQuest test. Excluding the equivocal results, the sensitivity and specificity expressed as 95% confidence intervals (95% Cl), of the SeraQuest Toxoplasma IgM test relative to the INCSTAR Toxoplasma IgM Clin-ELISA™ test, were 74.3 to 92.9% and 86.8 to 99.6% respectively. The overall agreement was 82.6 to 94.1%. {3}------------------------------------------------ #### APPENDIX 5. #### ABLE 1. ASSAYS, TOXOPLASMA laM AND INCSTAR RESULTS OF OF SeraQuest Clin-ELISA ASSAYS, OF SPECIMENS. 128 SERUM THE TOXOPLASMA IgM SPECIMENS INCLUDED: 24 SPECIMENS FROM NORMAL ASYMPTOMATIC 38 SPECIMENS FROM WOMEN BEING SCREENED PRENATALLY FOR DONORS: TOXOPLASMA ANTIBODIES; 16 SPECIMENS REPORTED TO BE POSITIVE FOR IgM ANTIBODIES TO TOXOPLASMA, WHICH WERE OBTAINED FROM SERUM BROKERS; AND 50 ACUTE PHASE SPECIMENS OBTAINED FROM TOXOPLASMA INFECTIONS. THESE TESTS WERE PERFORMED IN-HOUSE AT QUEST INTERNATIONAL, INC., MIAMI, FL. | INCSTAR | SeraQuest Toxoplasma IgM | | | | | | | |----------------|--------------------------|--------------------|-------|--|--------------------------------------|----------------|--| | Toxoplasma IgM | Positive | Equivocal Negative | | | 95 % Confidence Interval | | | | Positive | 51 | ব | 10 | | Relative sensitivity* 74.3 to 92.9√√ | | | | Equivocal | r | 0 | ર્ય | | | | | | Negative | ব | | રે રે | | Relative specificity* 86.8 to 99.6vV | | | | | | | | | Overall agreement* | 82.6 to 94.1VV | | Excluding equivocal results. VV Calculated by the normal method. (see Reference below). Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750. 1986. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle, with its wings spread. The eagle is facing to the right. The seal is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 2 1 1997 · Robert A. Cort Vice President, Quality Assurance Ouest International 1938 N.E. 148th Terrace North Miami, FL 33181 Re: K971672 Trade Name: SeraQuest Toxoplasma IgM Regulatory Class: II Product Code: LGD Dated: August 6, 1997 Received: August 6, 1997 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 regulation (21 CFR Part 820) and that, through periodic (OS) 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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}------------------------------------------------ APPENDIX 11 Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page 1 of 510(k) Number (if known): _ Kg 7-1672 Device Name: SeraQuest Toxoplasma IqM Indications For Use: - For the qualitative, semi-quantitative, and quantitative detection of IgM 1. antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. - 2. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection. - 3. Patient testing with the SeraQuest Toxoplasma IgM assay must be accompanied by an anti-toxoplasma IgG antibody assay. - 4. Useful for the above indications, with specimens obtained from women of childbearing age and during pregnancy. - ട. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K971672' Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)