← Product Code [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ) · K033601 # LABONE MICRO-PLATE COTININE EIA (K033601) _Labone, Inc. · DLJ · Feb 10, 2004 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033601 ## Device Facts - **Applicant:** Labone, Inc. - **Product Code:** [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ.md) - **Decision Date:** Feb 10, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3200 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology - **Attributes:** 3rd-Party Reviewed ## Indications for Use LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only. The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva. The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine. ## Device Story LabOne Micro-Plate Cotinine EIA is a solid-phase competitive enzyme immunoassay (EIA) used to detect cotinine in oral fluid. The device utilizes the OraSure Oral Fluid Specimen Collection Device for sample collection. The assay functions by measuring cotinine levels to identify recent tobacco or nicotine product use. It is intended for in vitro diagnostic use in a laboratory setting. The system includes specific calibrators to establish reference points and controls to monitor testing precision and accuracy. Healthcare providers use the qualitative or semi-quantitative results to assist in clinical assessments related to nicotine exposure. ## Clinical Evidence Bench testing only. Performance studies evaluated precision, analytical sensitivity, interference, and antibody cross-reactivity. Comparative testing against the predicate device using self-claimed patient specimens and diluted samples demonstrated substantial equivalence in results. ## Technological Characteristics Solid-phase competitive enzyme immunoassay (EIA) micro-plate format. Designed for use with OraSure Oral Fluid Specimen Collection Device. Includes associated calibrators and assayed quality control matrix. In vitro diagnostic use. ## Regulatory Identification A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.) ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - OraSure Micro-Plate Cotinine EIA ([K974234](/device/K974234.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # FEB 1 0 2004 ### 510(k) Summary-LabOne Micro-Plate Cotinine ELA This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 The assigned 510(k) number is K033601 #### Date of Summary: August 25th, 2003 #### Correspondent: Liuming Yu Name: 10101 Renner Boulevard Address: Lenexa, Kansas 66210-9752 Phone Number: 913-895-2308 Fax Number: 913-888-4186 #### Product Name: - Common Name: Micro-Plate Cotinine EIA Trade Name: LabOne Micro-Plate Cotinine EIA Classification Number: 862.3220 ### Substantially Equivalent Device: Product: OraSure Micro-Plate Cotinine EIA Manufactured by: OraSure® Technologies, Inc. 510(k) Number: K974234 #### Intended Use and Product Description: LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device. #### Comparison: LabOne Micro-Plate Cotinine ELA is substantially equivalent to the OraSure Micro-Plate Cotinine EIA when used to qualitatively and semi-quantitatively test cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device #### Comparison Performance Data: Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent to the OraSure Micro-Plate Cotinine EIA. Results tested from self-claimed patient specimens and diluted samples with both the LabOne Micro-Plate Cotinine EIA and the OraSure Micro-Plate Cotinine EIA also showed that the {1}------------------------------------------------ sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references. Conclusion: Islour. The Micro-Plate Cotinine EIA can be used to qualitatively and semi-quantitatively test cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. . {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol. Public Health Service FEB 1 0 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 LabOne, Inc c/o Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891 Re. k033601 Trade/Device Name: LabOne Micro-Plate Cotinine EIA Regulation Number: 21 CFR 862.3200 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DLJ; MKU Dated: January 26, 2004 Received: January 28, 2004 Dear Ms. Danielson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ #### Page 2 This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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, Jean M. Cooper, MS, DVM. Yean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indication for Use Statement 510(k) Number (if known) K_ Device Name: LabOne Micro-Plate Cotinine EIA ## Indication For Use: LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only. The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva. The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine. i ்ப Ovez - file - Conlen Prescription Allate C Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k033601 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033601](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033601) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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