MODIFIED CEDIA DAU PCP ASSAY

{0}------------------------------------------------ SEP 2 2 1997 ; ### K972963 BOEHRINGER MANNHEIM CORPORATION 510(k) Summary  Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | 1) Submitter name, address, contact | Boehringer Mannheim Corporation 2400 Bisso Lane Concord, CA 94524 (510) 674-0667 Fax: (510) 687-1850 Contact Person: Yvette Lloyd | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Date Prepared: August 8, 1997 | | 2) Device name | Proprietary name: CEDIA DAU PCP Assay Common name: Homonogeneous enzyme immunoassay for the determination of PCP levels in urine. Classification name: PCP test system | | 3) Predicate device | We claim substantial equivalence to the CEDIA DAU PCP Assay (K935650). | Continued on next page . {1}------------------------------------------------ #### BOEHRI Summarv. Continued ORPORATION Image /page/1/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with the word "mannheim" written vertically on the left side. Inside the square is a white circle with the word "boehringer" written inside it. The text is in a simple, sans-serif font. The CEDIA DAU PCP assay uses recombinant DNA technology (US Patent 4) Device Description No. 4708929) to produce a unique homogeneous enzyme immunoassay sy stem. This assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically . In the assay, drug in the sample competes with drug conjugated to one inactive fragment of B-galactosidase for antibody binding site. If drug is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If drug is not present in the sample, antibody binds to drug conjugated on the inactive fragment, inhibiting the reassociation of inactive B-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample. 5) Intended The Modified CEDIA DAU Phencyclidine Assay is a homogeneous enzyme use immunoassay for the qualitative and semi-quantitative assay of phencyclidine in human urine. Measurements are used as an aid in the diagnosis and treatment of phencyclidine use or overdose. Continued on next page {2}------------------------------------------------ ## Summary, Continued Image /page/2/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a white circle with the word "boehringer" inside it. To the left of the circle, the word "mannheim" is written vertically. The background of the logo is black. () Comparison to predicate device The Boehringer Mannheim modified CEDIA DAU PCP Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim CEDIA DAU PCP Assay (K935650). The following table compares the modified CEDIA DAU PCP Assay with the predicate device, CEDIA DAU PCP Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6. #### Similaritics: · Both assays are for qualitative and semiquantitative determination of PCPs in urine. · Same chemistry parameters #### Differences: · The modified CEDIA DAU PCP assay uses a different antibody and EDconjugate · The modified CEDIA DAU PCP assay has lower crossreactivity to diphenhydramine. Continued on next page {3}------------------------------------------------ ### Summary, Continued ORATION Image /page/3/Picture/1 description: The image shows a logo with the word "mannheim" written vertically on the left side. To the right of the word is a circle with the word "boehringer" inside. The background of the logo is black, and the text and circle are white. Performance Characteristics: 6) Comparison to predicate device, (cont.) | Feature | Modified CEDIA DAU PCP | CEDIA DAU PCP | |---------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------| | Precision | Modified NCCLS<br>(mA/min):<br>25 ng/mL Cutoff<br>Protocol | Modified NCCLS<br>(mA/min):<br>25 ng/mL Cutoff<br>Protocol | | Concentration<br>Level | 19 | 19 | | N | 126 | 120 | | Within-Run | 281.1 | 238.4 | | %CV | 0.7 | 1.0 | | Total | 281.1 | 238.4 | | %CV | 1.5 | 4.3 | | Concentration<br>Level | 25 | 25 | | N | 126 | 120 | | Within-Run | 323.1 | 276.4 | | %CV | 0.7 | 1.2 | | Total | 323.1 | 276.4 | | %CV | 1.5 | 5.3 | | Concentration<br>Level | 31 | 31 | | N | 126 | 120 | | Within-Run | 370.4 | 316.3 | | %CV | 0.6 | 1.1 | | Total | 370.4 | 316.3 | | %CV | 1.4 | 5.0 | | Qualitative<br>Sensitivity<br>25ng/mL Cutoff | 1.05 ng/ml | 1.7 ng/ml | | Semiquantitative<br>Sensitivity<br>25ng/mL Cutoff | 0.96 ng/ml | N/A | | Accuracy | Vs. CEDIA PCP Assay | Vs. Commercially available EIA Assay | | 25 ng/mL Cutoff<br>Sensitivity | 96.9% | 99.1 | | Specificity | 100.0% | 100.0% | Continued on next page {4}------------------------------------------------ #### BOEHRIN (k) Summary, Continued CORPORATION Image /page/4/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with a white circle inside. The word "boehringer" is written in white inside the circle. The word "mannheim" is written vertically in white on the left side of the square. # Comparison to predicate device (cont.) | Feature | Modified CEDIA DAU<br>PCP | CEDIA DAU PCP | |---------------------------|---------------------------|-------------------------| | Interfering<br>substances | Less than 10% error at: | Less than 10% error at: | | Acetone | 1 g/dL | 1 g/dL | | Ascorbic Acid | 1.5 g/dL | 1.5 g/dL | | Creatinine | 0.5 g/dL | 0.5 g/dL | | Ethanol | 1 g/dL | 1 g/dL | | Galactose | 10 mg/dL | 10 mg/dL | | y-globulin | 0.5 g/dL | 0.5 g/dL | | Glucose | 3 g/dL | 3 g/dL | | Hemoglobin | 0.3 g/dL | 0.3 g/dL | | Human Serum<br>Albumin | 0.5 g/L | 0.5 g/L | | Oxalic Acid | 0.1g/dL | 0.1g/dL | | Riboflavin | 7.5 mg/dL | 7.5 mg/dL | | Sodium Chloride | 6 g/dL | 6 g/dL | | Urea | 5 g/dL | 3 g/dL | | Specificity | Multiple PCP compounds | Multiple PCP compounds | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them. SEP 22 1997 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Yvette Lloyd .Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 94524-4117 Concord, California Re : K972963 CEDIA DAU PCP Assay Requlatory Class: II Product Code: LCM Dated: August 8, 1997 Received: August 11, 1997 Dear Ms. Lloyd: 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਰੇ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 . {6}------------------------------------------------ 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/dsmamain.html". Sincerely yours, Steven Bitman 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 {7}------------------------------------------------ :10(k) Number (if known): N/A lxvice Name: CEDIA® DAU PCP Assay Indications For Use: The modified CEDIA® DAU PCP Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative assay of PCPs in human urine. Measurements are used as an aid in the diagnosis and treatment of PCP use or overdose. Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use 1 (Optional Format 1-2-96) (Division Sign-Off Division of Clinic 510(k) Number. AK2963